Trial Outcomes & Findings for Neuromodulation Enhanced Cognitive Restructuring: A Proof of Concept Study (NCT NCT02573246)
NCT ID: NCT02573246
Last Updated: 2021-07-16
Results Overview
The estimated marginal mean of the difference in length of time that it takes participants to reduce emotional arousal after three emotional inductions when they use Cognitive Restructuring (CR) with or without the enhancing effects of transcranial magnetic stimulation (TMS). Psychophysiological measurements were collected continuously using the BIOPAC MP-150. For each baseline, heart rate (HR) was averaged from the last 240s. Time to return to one's HR baseline was defined as the amount of time (e.g., number of seconds) it took from the beginning of regulation for the continuously monitored HR to reach a value that was lower than the average pre-stimulus baseline HR. Lower numbers indicate quicker regulation (desirable outcome). A baseline value for regulation duration was computed as the time it took during habituation for the person to return to HR baseline. Number of seconds was transformed with a logarithmic function for analyses to achieve normality.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
148 participants
Primary outcome timeframe
1 week after intake
Results posted on
2021-07-16
Participant Flow
Recruitment from the community occurred between 3/1/2016 and 2/17/2019 . Additional funding was received in 2017 to collect additional data. Two conditions were added where procedures were identical but targeting for neurostimulation was done using functional neuroimaging data. Participants were recruited for both the study and the sub study and assigned to one at intake.
We enrolled 148 participants in both studies of which 78 were randomized in one of the two studies (main study or sub study). Twenty seven participants decided to withdraw after intake.In addition, 42 participants were excluded after enrollment (e.g., TMS was contraindicated, did not meet criteria for any DSM disorder, had current psychosis/mania/addiction, etc). One participant piloted the procedures and was also excluded from analyses.
Participant milestones
| Measure |
Cognitive Restructuring+rTMS (Left)
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using the 10-20 system.
rTMS: rTMS is a neurostimulation intervention where the participant receives 15 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses
|
Cognitive Restructuring + Sham rTMS
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant.
|
Cognitive Restructuring+rTMS (Right)
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 15 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses
|
Cognitive Restructuring+rTMS (Left) With Functional Targeting
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 15 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses
|
Cognitive Restructuring + Sham rTMS With Functional Targeting
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
18
|
16
|
15
|
|
Overall Study
COMPLETED
|
11
|
14
|
15
|
14
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
3
|
2
|
4
|
Reasons for withdrawal
| Measure |
Cognitive Restructuring+rTMS (Left)
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using the 10-20 system.
rTMS: rTMS is a neurostimulation intervention where the participant receives 15 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses
|
Cognitive Restructuring + Sham rTMS
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant.
|
Cognitive Restructuring+rTMS (Right)
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 15 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses
|
Cognitive Restructuring+rTMS (Left) With Functional Targeting
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 15 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses
|
Cognitive Restructuring + Sham rTMS With Functional Targeting
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
3
|
2
|
2
|
Baseline Characteristics
Neuromodulation Enhanced Cognitive Restructuring: A Proof of Concept Study
Baseline characteristics by cohort
| Measure |
Cognitive Restructuring+rTMS (Left)
n=13 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using the 10-20 system.
rTMS: rTMS is a neurostimulation intervention where the participant receives 15 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses
|
Cognitive Restructuring + Sham rTMS
n=14 Participants
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant.
|
Cognitive Restructuring+rTMS (Right)
n=15 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 15 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses
|
Cognitive Restructuring+rTMS (Left) With Functional Targeting
n=14 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 15 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses
|
Cognitive Restructuring + Sham rTMS With Functional Targeting
n=13 Participants
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
32.08 years
STANDARD_DEVIATION 13.77 • n=5 Participants
|
29.43 years
STANDARD_DEVIATION 10.95 • n=7 Participants
|
28.80 years
STANDARD_DEVIATION 7.07 • n=5 Participants
|
32.64 years
STANDARD_DEVIATION 14.19 • n=4 Participants
|
35.77 years
STANDARD_DEVIATION 13.50 • n=21 Participants
|
31.64 years
STANDARD_DEVIATION 11.98 • n=8 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
58 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
61 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
44 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
69 Participants
n=8 Participants
|
|
ERQ Reappraisal Score
|
3.26 units on a scale
STANDARD_DEVIATION 0.87 • n=5 Participants
|
3.21 units on a scale
STANDARD_DEVIATION 0.76 • n=7 Participants
|
3.51 units on a scale
STANDARD_DEVIATION 0.79 • n=5 Participants
|
4.10 units on a scale
STANDARD_DEVIATION 1.35 • n=4 Participants
|
4.44 units on a scale
STANDARD_DEVIATION 1.33 • n=21 Participants
|
3.70 units on a scale
STANDARD_DEVIATION 1.12 • n=8 Participants
|
|
DERS Total Score
|
93.54 units on a scale
STANDARD_DEVIATION 27.55 • n=5 Participants
|
118.57 units on a scale
STANDARD_DEVIATION 13.72 • n=7 Participants
|
95.67 units on a scale
STANDARD_DEVIATION 19.05 • n=5 Participants
|
109.57 units on a scale
STANDARD_DEVIATION 17.02 • n=4 Participants
|
110.39 units on a scale
STANDARD_DEVIATION 18.54 • n=21 Participants
|
105.51 units on a scale
STANDARD_DEVIATION 21.27 • n=8 Participants
|
PRIMARY outcome
Timeframe: 1 week after intakePopulation: Each participant went through three stressor-regulation periods during the intervention. Only those who stressed at least during one of the three stressor periods were included in this analysis. Missing participants from the total ITT sample did not stress at all during the intervention stressor tasks. The results presented are estimated marginal means from the MMANOVA analysis that included this information
The estimated marginal mean of the difference in length of time that it takes participants to reduce emotional arousal after three emotional inductions when they use Cognitive Restructuring (CR) with or without the enhancing effects of transcranial magnetic stimulation (TMS). Psychophysiological measurements were collected continuously using the BIOPAC MP-150. For each baseline, heart rate (HR) was averaged from the last 240s. Time to return to one's HR baseline was defined as the amount of time (e.g., number of seconds) it took from the beginning of regulation for the continuously monitored HR to reach a value that was lower than the average pre-stimulus baseline HR. Lower numbers indicate quicker regulation (desirable outcome). A baseline value for regulation duration was computed as the time it took during habituation for the person to return to HR baseline. Number of seconds was transformed with a logarithmic function for analyses to achieve normality.
Outcome measures
| Measure |
Cognitive Restructuring+rTMS (Left)
n=12 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using the 10-20 system.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring + Sham rTMS
n=11 Participants
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. Sound and scalp stimulation made the experience similar to active neurostimulation.
|
Cognitive Restructuring+rTMS (Right)
n=13 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring+rTMS (Left) With Functional Targeting
n=11 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring + Sham rTMS With Functional Targeting
n=10 Participants
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. A specific neurostimulation target for the sham stimulation will be established using neuroimaging functional data. Sound and scalp stimulation made the experience similar to active neurostimulation.
|
|---|---|---|---|---|---|
|
Time to Return to Heart Rate Baseline During the Regulation Period During Training
|
1.591 log (seconds)
Standard Error .093
|
1.828 log (seconds)
Standard Error .095
|
1.505 log (seconds)
Standard Error .089
|
1.534475 log (seconds)
Standard Error .154
|
1.946232 log (seconds)
Standard Error .173
|
PRIMARY outcome
Timeframe: 1 monthPopulation: only participants who "stressed" during the follow up stressor task (i.e., their heart rate was above baseline at the beginning of the follow up regulation period) were included in these analyses. Missing participants did not stress at follow up.
The investigators will examine difference in length of time that it takes participants to reduce emotional arousal (as measured with physiological indicators) after an emotional induction when they use CR. This measure, was collected at the 1 month follow up assessment. Only one stressor-regulation period was presented at follow up. The number of seconds it took for participants to return to the pre-stimulus baseline during the regulation period was transformed with a log function for normality. Lower numbers indicate quicker regulation, a desirable outcome.
Outcome measures
| Measure |
Cognitive Restructuring+rTMS (Left)
n=8 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using the 10-20 system.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring + Sham rTMS
n=9 Participants
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. Sound and scalp stimulation made the experience similar to active neurostimulation.
|
Cognitive Restructuring+rTMS (Right)
n=10 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring+rTMS (Left) With Functional Targeting
n=9 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring + Sham rTMS With Functional Targeting
n=5 Participants
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. A specific neurostimulation target for the sham stimulation will be established using neuroimaging functional data. Sound and scalp stimulation made the experience similar to active neurostimulation.
|
|---|---|---|---|---|---|
|
Time to Return to Heart Rate Baseline During the Regulation Period at Follow up
|
1.448 log (seconds)
Standard Error 0.089
|
1.286 log (seconds)
Standard Error 0.062
|
1.1474 log (seconds)
Standard Error 0.110
|
1.5535 log (seconds)
Standard Error 0.0936
|
1.4055 log (seconds)
Standard Error 0.14923
|
PRIMARY outcome
Timeframe: 1 week after study startThe investigators will record heart rate continuously throughout the intervention and then extract high frequency heart rate variability (an index of emotion regulation) from the regulation periods. Continuously recorded HR was divided into 120 s bins, and HF-HRV was extracted from cleaned raw ECG from each bin. Baseline HF-HRV was measured at the beginning of the experiment and right before each autobiographical stressor presentation. The treatment condition (active left, active right, or sham), baselines, the experimental condition (regulation 1, 2, and 3), and the time within each experimental condition (0 to 4 for each 120 s segment within that period) were used to predict HF-HRV. Higher HF-HRV indicates enhanced regulation, a desirable outcome. To make interpretation easier, the raw HF-HRV score was multiplied with 1000000. To achieve normality, this multiplied score was transformed with a logarithmic function.
Outcome measures
| Measure |
Cognitive Restructuring+rTMS (Left)
n=13 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using the 10-20 system.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring + Sham rTMS
n=14 Participants
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. Sound and scalp stimulation made the experience similar to active neurostimulation.
|
Cognitive Restructuring+rTMS (Right)
n=15 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring+rTMS (Left) With Functional Targeting
n=14 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring + Sham rTMS With Functional Targeting
n=13 Participants
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. A specific neurostimulation target for the sham stimulation will be established using neuroimaging functional data. Sound and scalp stimulation made the experience similar to active neurostimulation.
|
|---|---|---|---|---|---|
|
Physiological Emotion Regulation
|
1.919 lg(1000000*milliseconds)
Standard Error .041
|
1.763 lg(1000000*milliseconds)
Standard Error .039
|
1.869 lg(1000000*milliseconds)
Standard Error .038
|
1.722 lg(1000000*milliseconds)
Standard Error .016
|
1.549 lg(1000000*milliseconds)
Standard Error .017
|
PRIMARY outcome
Timeframe: 1 weekPopulation: This data was not collected from all participants. It was only collected for a subset of participants assigned to the imaging sub study (groups 4 and 5). The numbers presented represent estimated marginal means from the MANCOVA analysis comparing conditions and covarying maximum activation within the contrast at intake.
For groups 4 \&5, the investigators collected functional imaging data while participants engaged in an emotion regulation task. We examined the BOLD response change in the contrast between down-regulating negative emotions and feeling negative emotions a week after intervention controlling for the maximum change in this contrast at intake. Specifically we examined changes in activation in the dorsolateral prefrontal cortex (dlPFC), ventrolateral PFC (vlPFC), ventromedial PFC (vmPFC), the amygdala and insula. Data were first preprocessed with fMRIprep and MRIQC. At the first level, functional data were analyzed as individual runs, using a general linear model (GLM) in which trial events were convolved with a double-gamma hemodynamic response function. The \[Restructure- Feel\_negative\] contrast was then used to generate Level 2 analysis, in which BOLD activity for each of the four runs were combined using a fixed-effect model. Higher numbers indicate more activation (desired outcome).
Outcome measures
| Measure |
Cognitive Restructuring+rTMS (Left)
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using the 10-20 system.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring + Sham rTMS
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. Sound and scalp stimulation made the experience similar to active neurostimulation.
|
Cognitive Restructuring+rTMS (Right)
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring+rTMS (Left) With Functional Targeting
n=13 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring + Sham rTMS With Functional Targeting
n=13 Participants
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. A specific neurostimulation target for the sham stimulation will be established using neuroimaging functional data. Sound and scalp stimulation made the experience similar to active neurostimulation.
|
|---|---|---|---|---|---|
|
Changes in Activation in the Neural Emotion Regulation Network
dlPFC
|
—
|
—
|
—
|
0.573 Maximum % signal change in ROI
Standard Error .065
|
.462 Maximum % signal change in ROI
Standard Error .065
|
|
Changes in Activation in the Neural Emotion Regulation Network
vlPFC
|
—
|
—
|
—
|
0.965 Maximum % signal change in ROI
Standard Error 0.102
|
0.606 Maximum % signal change in ROI
Standard Error 0.102
|
|
Changes in Activation in the Neural Emotion Regulation Network
vmPFC
|
—
|
—
|
—
|
2.597 Maximum % signal change in ROI
Standard Error 0.326
|
2.376 Maximum % signal change in ROI
Standard Error 0.326
|
|
Changes in Activation in the Neural Emotion Regulation Network
amygdala
|
—
|
—
|
—
|
0.664 Maximum % signal change in ROI
Standard Error 0.125
|
0.485 Maximum % signal change in ROI
Standard Error 0.125
|
|
Changes in Activation in the Neural Emotion Regulation Network
Insula
|
—
|
—
|
—
|
.543 Maximum % signal change in ROI
Standard Error 0.05
|
.522 Maximum % signal change in ROI
Standard Error 0.05
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Only participants who were not lost to contact by the last session of the study provided data for this outcome measure. One participant did not complete the acceptability portion of the exit interview and as a result their data cannot be included.
The investigators will examine how acceptable participants find the intervention. A previously developed in-house interview (A. D. Neacsiu, Luber, et al., 2018) was administered at the 1-month follow up, and it included Likert-type questions about feasibility, acceptability, and overall satisfaction rated on a scale from 0 (not at all) to 9 (extremely; secondary outcomes).
Outcome measures
| Measure |
Cognitive Restructuring+rTMS (Left)
n=11 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using the 10-20 system.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring + Sham rTMS
n=14 Participants
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. Sound and scalp stimulation made the experience similar to active neurostimulation.
|
Cognitive Restructuring+rTMS (Right)
n=14 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring+rTMS (Left) With Functional Targeting
n=14 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring + Sham rTMS With Functional Targeting
n=11 Participants
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. A specific neurostimulation target for the sham stimulation will be established using neuroimaging functional data. Sound and scalp stimulation made the experience similar to active neurostimulation.
|
|---|---|---|---|---|---|
|
Acceptability, as Measured by Qualitative Exit Interview
|
7.11 units on a scale
Standard Deviation 1.07
|
7.48 units on a scale
Standard Deviation 0.92
|
7.20 units on a scale
Standard Deviation 1.34
|
6.99 units on a scale
Standard Deviation 1.25
|
7.65 units on a scale
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: 1 monthPopulation: Only participants who were not lost to contact by the last study session provided data for this analysis.
The investigators will examine how feasible the proposed intervention is. A previously developed in-house interview (A. D. Neacsiu, Luber, et al., 2018) was administered at the 1-month follow up, and it included Likert-type questions about feasibility, acceptability, and overall satisfaction rated on a scale from 0 (not at all) to 9 (extremely; secondary outcomes).
Outcome measures
| Measure |
Cognitive Restructuring+rTMS (Left)
n=11 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using the 10-20 system.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring + Sham rTMS
n=14 Participants
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. Sound and scalp stimulation made the experience similar to active neurostimulation.
|
Cognitive Restructuring+rTMS (Right)
n=15 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring+rTMS (Left) With Functional Targeting
n=14 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring + Sham rTMS With Functional Targeting
n=11 Participants
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. A specific neurostimulation target for the sham stimulation will be established using neuroimaging functional data. Sound and scalp stimulation made the experience similar to active neurostimulation.
|
|---|---|---|---|---|---|
|
Feasibility, as Measured by Qualitative Exit Interview
|
6.4545 units on a scale
Standard Deviation 0.83
|
6.7500 units on a scale
Standard Deviation 0.87
|
6.7481 units on a scale
Standard Deviation 0.555
|
6.3651 units on a scale
Standard Deviation 0.886
|
6.4646 units on a scale
Standard Deviation 0.9645
|
SECONDARY outcome
Timeframe: 1 week and 1 monthPopulation: Only participants who provided data were included. In the first study (first 3 groups) one participant from the active right condition did not complete the 1-week follow-up self-reports. One sham, three active left, and one active right participant could not tolerate the intervention and dropped. In the second study (last 2 groups) two participants could not tolerate the intervention and dropped in each condition. One participant in sham did not complete his OQ-45 measure at follow up.
The investigators will examine change in general psychological distress after the intervention. The Outcome Questionnaire-45 (OQ-45) is a 45-item self-report measure used to track severity of psychopathology throughout treatment. It consists of subscales that identify three types of problems that lead to general stress: psychological symptoms, interpersonal conflicts, and problems with social roles. Items are rated on a Likert scale ranging from 0 (never) to 4 (almost always). We computed the total score (ranging from 0 to 180) from data collected at intake, at 1 week after the intervention, and at 1 month after the intervention. Higher score indicate higher psychopathological distress than lower scores. The estimated marginal means from the growth model comparing differences between conditions are presented in the table below.
Outcome measures
| Measure |
Cognitive Restructuring+rTMS (Left)
n=13 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using the 10-20 system.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring + Sham rTMS
n=14 Participants
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. Sound and scalp stimulation made the experience similar to active neurostimulation.
|
Cognitive Restructuring+rTMS (Right)
n=14 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring+rTMS (Left) With Functional Targeting
n=14 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring + Sham rTMS With Functional Targeting
n=12 Participants
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. A specific neurostimulation target for the sham stimulation will be established using neuroimaging functional data. Sound and scalp stimulation made the experience similar to active neurostimulation.
|
|---|---|---|---|---|---|
|
Change in General Psychological Distress, as Measured by the Outcome Questionaire -45
|
59.996 score on a scale
Standard Error 5.48
|
53.955 score on a scale
Standard Error 5.29
|
53.049 score on a scale
Standard Error 5.06
|
74.41 score on a scale
Standard Error 5.45
|
63.95 score on a scale
Standard Error 5.73
|
SECONDARY outcome
Timeframe: 1 weekThe investigators will examine change in emotional distress after the intervention as measured by daily mobile phone ratings 8 times/day for 7 days of subjective units of distress; SUDS). The 8 ratings/day will then be averaged into a mean/day. This daily SUDS mean (range 0-9) will be entered in analyses. Higher SUDS indicates more distress.
Outcome measures
| Measure |
Cognitive Restructuring+rTMS (Left)
n=13 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using the 10-20 system.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring + Sham rTMS
n=14 Participants
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. Sound and scalp stimulation made the experience similar to active neurostimulation.
|
Cognitive Restructuring+rTMS (Right)
n=15 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring+rTMS (Left) With Functional Targeting
n=14 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring + Sham rTMS With Functional Targeting
n=13 Participants
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. A specific neurostimulation target for the sham stimulation will be established using neuroimaging functional data. Sound and scalp stimulation made the experience similar to active neurostimulation.
|
|---|---|---|---|---|---|
|
Change in Daily General Emotional Distress
|
1.388 units on a scale per day
Standard Error 0.217
|
1.941 units on a scale per day
Standard Error 0.212
|
1.791 units on a scale per day
Standard Error 0.205
|
2.026 units on a scale per day
Standard Error 0.269
|
1.395 units on a scale per day
Standard Error 0.293
|
SECONDARY outcome
Timeframe: 1 week and 1 month after the interventionPopulation: Only participants who provided data were included. In the first study (first 3 groups) one participant from the active right condition did not complete the 1-week follow-up self-reports. One sham, three active left, and one active right participant could not tolerate the intervention and dropped. In the second study (last 2 groups) two participants could not tolerate the intervention and dropped in each condition. One participant in sham did not complete his self-report measures at follow up.
The investigators will examine changes in the reappraisal scale of the Emotion Regulation Questionnaire (ERQ; range 1-7), in the total score from the Difficulties with Emotion Regulation Scale (DERS; range 36-180), and in the total score from the work and social adjustment functional impairment scale (WSAS; range 0-40) from before to after the one time intervention. Higher ERQ-Reappraisal scores indicate more use of cognitive restructuring (a favorable outcome). Lower DERS total score and lower WSAS average score indicate lower overall emotional dysregulation and lower impairment in functioning, which are desirable outcomes. Outcomes were analyzed using HLM models and the data presented below represents the estimate marginal means for each condition for the growth in each outcome controlling for baseline.
Outcome measures
| Measure |
Cognitive Restructuring+rTMS (Left)
n=13 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using the 10-20 system.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring + Sham rTMS
n=14 Participants
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. Sound and scalp stimulation made the experience similar to active neurostimulation.
|
Cognitive Restructuring+rTMS (Right)
n=14 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring+rTMS (Left) With Functional Targeting
n=14 Participants
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring + Sham rTMS With Functional Targeting
n=12 Participants
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. A specific neurostimulation target for the sham stimulation will be established using neuroimaging functional data. Sound and scalp stimulation made the experience similar to active neurostimulation.
|
|---|---|---|---|---|---|
|
Change in Emotion Dysregulation and Functional Impairment
Difficulties in emotion regulation total score
|
88.413631 score on a scale
Standard Error 6.419510
|
89.341540 score on a scale
Standard Error 6.497500
|
79.212163 score on a scale
Standard Error 5.890947
|
99.447060 score on a scale
Standard Error 86.259744
|
4.289242 score on a scale
Standard Error 4.489399
|
|
Change in Emotion Dysregulation and Functional Impairment
ERQ-Reappraisal
|
4.493290 score on a scale
Standard Error 0.20
|
4.777880 score on a scale
Standard Error 0.19
|
4.795426 score on a scale
Standard Error 0.19
|
4.838261 score on a scale
Standard Error 0.267571
|
4.741542 score on a scale
Standard Error 0.281177
|
|
Change in Emotion Dysregulation and Functional Impairment
Work and Social Functioning Impairment
|
12.176969 score on a scale
Standard Error 1.941534
|
10.876197 score on a scale
Standard Error 1.834403
|
11.853591 score on a scale
Standard Error 1.849822
|
14.255798 score on a scale
Standard Error 2.290357
|
10.963661 score on a scale
Standard Error 2.295986
|
Adverse Events
Cognitive Restructuring+rTMS (Left)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cognitive Restructuring + Sham rTMS
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cognitive Restructuring+rTMS (Right)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Cognitive Restructuring+rTMS (Left) With Functional Targeting
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cognitive Restructuring + Sham rTMS With Functional Targeting
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cognitive Restructuring+rTMS (Left)
n=14 participants at risk
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using the 10-20 system.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring + Sham rTMS
n=15 participants at risk
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. Sound and scalp stimulation made the experience similar to active neurostimulation.
|
Cognitive Restructuring+rTMS (Right)
n=18 participants at risk
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the right side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using the 10-20 system (i.e., scalp measurements).
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring+rTMS (Left) With Functional Targeting
n=16 participants at risk
Participants in this arm will be administered the neuromodulation enhanced cognitive restructuring intervention over the left side of the brain and will partake in short term and long term follow up testing. The specific neurostimulation target will be established using neuroimaging functional data.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
rTMS: rTMS is a neurostimulation intervention where the participant receives 40 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses (4 s train, 26s inter-train interval). The first 10 minutes of neurostimulation will happen during a habituation period in the absence of emotional induction and cognitive restructuring. the rest of 30 minutes will happen in chunks of 10 minutes, following a 2 minute negative emotional induction using autobiographical stressors, while the participant engages in cognitive restructuring.
|
Cognitive Restructuring + Sham rTMS With Functional Targeting
n=15 participants at risk
Participants in this arm will receive cognitive restructuring alone as an active intervention and will partake in short term and long term follow up testing.
Cognitive Restructuring: Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.The specific neurostimulation target will be established using neuroimaging functional data.
Sham rTMS: Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant. A specific neurostimulation target for the sham stimulation will be established using neuroimaging functional data. Sound and scalp stimulation made the experience similar to active neurostimulation.
|
|---|---|---|---|---|---|
|
Psychiatric disorders
Manic like mood
|
0.00%
0/14 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
0.00%
0/15 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
0.00%
0/18 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
6.2%
1/16 • Number of events 1 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
0.00%
0/15 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
|
Musculoskeletal and connective tissue disorders
Scalp Pain
|
14.3%
2/14 • Number of events 2 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
22.2%
4/18 • Number of events 4 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
12.5%
2/16 • Number of events 2 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
0.00%
0/15 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
|
Psychiatric disorders
Panic Attack
|
0.00%
0/14 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
0.00%
0/15 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
5.6%
1/18 • Number of events 1 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
0.00%
0/16 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
0.00%
0/15 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
0.00%
0/18 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
0.00%
0/16 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
|
Nervous system disorders
Headache
|
42.9%
6/14 • Number of events 6 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
40.0%
6/15 • Number of events 6 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
44.4%
8/18 • Number of events 8 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
43.8%
7/16 • Number of events 7 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
20.0%
3/15 • Number of events 3 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
|
Psychiatric disorders
Increased Anxiety
|
7.1%
1/14 • Number of events 1 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
0.00%
0/15 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
0.00%
0/18 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
0.00%
0/16 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
0.00%
0/15 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
|
Nervous system disorders
Presyncopal episode
|
0.00%
0/14 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
0.00%
0/15 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
0.00%
0/18 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
0.00%
0/16 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
6.7%
1/15 • Number of events 1 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
|
Ear and labyrinth disorders
mild hearing impairment
|
7.1%
1/14 • Number of events 1 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
0.00%
0/15 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
0.00%
0/18 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
0.00%
0/16 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
0.00%
0/15 • Adverse events were collected for each participant throughout their participation in the study (approximately 1-2 months/participant). Adverse event data was collected starting after signing consent through completion of the follow-up final visit- about a 1-2 month time frame for each individual. If an individual was lost to contact or dropped, AE data collection ended at that point. Once the individual completed the study, AE data was no longer collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place