Trial Outcomes & Findings for Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention (NCT NCT05113277)
NCT ID: NCT05113277
Last Updated: 2024-08-23
Results Overview
PTSD symptoms measured using the posttraumatic stress checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item scale with values ranging from 0 to 4 for each item. Items are totaled for a total score ranging 0 to 80, with lower values indicating better outcomes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
up to 1 month
Results posted on
2024-08-23
Participant Flow
Participant milestones
| Measure |
Tonic Immobility Psychoeducation (TIP)
Participants in the experimental condition will receive the TIP intervention.
Tonic Immobility Psychoeducation (TIP): TIP is a 45-minute computerized psychoeducation intervention aimed at addressing maladaptive cognitions and emotions associated with TI while using educational and behavioral techniques commonly used in the treatment of trauma-related disorders. Throughout the psychoeducation program vignettes will be presented to clarify concepts and promote participant engagement. In addition, practice exercises and rating scales will be integrated, where applicable, to increase the interactive nature of the program. The following modules will be addressed in the TI psychoeducation intervention: education, myth busting, and behavioral experiments.
|
Health Education Training (HET)
Participants in the control condition will receive the HET intervention.
Health Education Training (HET): The Healthy Education Training intervention was developed as a 45-minute online intervention that provides education about physical health habits that can impact mental health, such as diet, exercise, and sleep. This intervention has been used in prior clinical trials to control for effects of general education, general coping techniques, and use of technology. Participants in past clinical trials have reported that HET is engaging and beneficial. However, HET is not expected to have an effect on the main symptom outcomes of the current study (guilt, shame, PTSD symptoms).
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
25
|
|
Overall Study
COMPLETED
|
18
|
17
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention
Baseline characteristics by cohort
| Measure |
Tonic Immobility Psychoeducation (TIP)
n=26 Participants
Participants in the experimental condition will receive the TIP intervention.
Tonic Immobility Psychoeducation (TIP): TIP is a 45-minute computerized psychoeducation intervention aimed at addressing maladaptive cognitions and emotions associated with TI while using educational and behavioral techniques commonly used in the treatment of trauma-related disorders. Throughout the psychoeducation program vignettes will be presented to clarify concepts and promote participant engagement. In addition, practice exercises and rating scales will be integrated, where applicable, to increase the interactive nature of the program. The following modules will be addressed in the TI psychoeducation intervention: education, myth busting, and behavioral experiments.
|
Health Education Training (HET)
n=25 Participants
Participants in the control condition will receive the HET intervention.
Health Education Training (HET): The Healthy Education Training intervention was developed as a 45-minute online intervention that provides education about physical health habits that can impact mental health, such as diet, exercise, and sleep. This intervention has been used in prior clinical trials to control for effects of general education, general coping techniques, and use of technology. Participants in past clinical trials have reported that HET is engaging and beneficial. However, HET is not expected to have an effect on the main symptom outcomes of the current study (guilt, shame, PTSD symptoms).
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.65 years
STANDARD_DEVIATION 8.90 • n=5 Participants
|
21.48 years
STANDARD_DEVIATION 5.85 • n=7 Participants
|
22.59 years
STANDARD_DEVIATION 7.57 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
25 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Posttraumatic Stress Checklist for DSM-5
|
51.85 units on a scale
STANDARD_DEVIATION 14.15 • n=5 Participants
|
46.6 units on a scale
STANDARD_DEVIATION 16.04 • n=7 Participants
|
49.27 units on a scale
STANDARD_DEVIATION 15.19 • n=5 Participants
|
|
State Shame (State Shame Guilt Scale)
|
9.65 units on a scale
STANDARD_DEVIATION 4.57 • n=5 Participants
|
9.36 units on a scale
STANDARD_DEVIATION 4.83 • n=7 Participants
|
9.51 units on a scale
STANDARD_DEVIATION 4.65 • n=5 Participants
|
|
Posttraumatic Cognitions Inventory
|
126.50 units on a scale
STANDARD_DEVIATION 39.09 • n=5 Participants
|
111.38 units on a scale
STANDARD_DEVIATION 36.63 • n=7 Participants
|
119.44 units on a scale
STANDARD_DEVIATION 38.30 • n=5 Participants
|
|
Negative Affect
|
25.24 units on a scale
STANDARD_DEVIATION 8.46 • n=5 Participants
|
26.32 units on a scale
STANDARD_DEVIATION 8.13 • n=7 Participants
|
25.78 units on a scale
STANDARD_DEVIATION 8.23 • n=5 Participants
|
|
Anxiety Sensitivity Inventory 3
|
35.24 units on a scale
STANDARD_DEVIATION 16.05 • n=5 Participants
|
36.68 units on a scale
STANDARD_DEVIATION 13.85 • n=7 Participants
|
35.96 units on a scale
STANDARD_DEVIATION 14.85 • n=5 Participants
|
|
Life Events Checklist for DSM-5
|
13.77 Number of items endorsed
STANDARD_DEVIATION 6.94 • n=5 Participants
|
12.6 Number of items endorsed
STANDARD_DEVIATION 5.33 • n=7 Participants
|
13.20 Number of items endorsed
STANDARD_DEVIATION 6.17 • n=5 Participants
|
|
Tonic Immobility Questionnaire
|
32.08 units on a scale
STANDARD_DEVIATION 11.22 • n=5 Participants
|
32.92 units on a scale
STANDARD_DEVIATION 12.03 • n=7 Participants
|
32.49 units on a scale
STANDARD_DEVIATION 11.51 • n=5 Participants
|
|
State Guilt (State Shame Guilt Scale)
|
10.50 units on a scale
STANDARD_DEVIATION 5.03 • n=5 Participants
|
8.40 units on a scale
STANDARD_DEVIATION 4.75 • n=7 Participants
|
9.47 units on a scale
STANDARD_DEVIATION 4.96 • n=5 Participants
|
PRIMARY outcome
Timeframe: up to 1 monthPopulation: The final sample was comprised of 46 individuals. Of the 51 participants recruited, three participants failed to complete the intervention, as determined at the analysis phase after examining total time spent, and two participants were excluded from analyses due to significantly impairing drug use during the TI experience.
PTSD symptoms measured using the posttraumatic stress checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item scale with values ranging from 0 to 4 for each item. Items are totaled for a total score ranging 0 to 80, with lower values indicating better outcomes.
Outcome measures
| Measure |
Tonic Immobility Psychoeducation (TIP)
n=25 Participants
Participants in the experimental condition will receive the TIP intervention.
Tonic Immobility Psychoeducation (TIP): TIP is a 45-minute computerized psychoeducation intervention aimed at addressing maladaptive cognitions and emotions associated with TI while using educational and behavioral techniques commonly used in the treatment of trauma-related disorders. Throughout the psychoeducation program vignettes will be presented to clarify concepts and promote participant engagement. In addition, practice exercises and rating scales will be integrated, where applicable, to increase the interactive nature of the program. The following modules will be addressed in the TI psychoeducation intervention: education, myth busting, and behavioral experiments.
|
Health Education Training (HET)
n=21 Participants
Participants in the control condition will receive the HET intervention.
Health Education Training (HET): The Healthy Education Training intervention was developed as a 45-minute online intervention that provides education about physical health habits that can impact mental health, such as diet, exercise, and sleep. This intervention has been used in prior clinical trials to control for effects of general education, general coping techniques, and use of technology. Participants in past clinical trials have reported that HET is engaging and beneficial. However, HET is not expected to have an effect on the main symptom outcomes of the current study (guilt, shame, PTSD symptoms).
|
|---|---|---|
|
Posttraumatic Stress Disorder Symptoms
|
30.41 units on a scale
Standard Deviation 18.23
|
31.93 units on a scale
Standard Deviation 18.33
|
PRIMARY outcome
Timeframe: post-intervention, on Day 1Population: The final sample was comprised of 46 individuals. Of the 51 participants recruited, three participants failed to complete the intervention, as determined at the analysis phase after examining total time spent, and two participants were excluded from analyses due to significantly impairing drug use during the TI experience.
Feelings of guilt as measured using the state shame-guilt scale, 8-item (SSGS-8); Value range = 5 to 20 with lower values indicating better outcomes.
Outcome measures
| Measure |
Tonic Immobility Psychoeducation (TIP)
n=25 Participants
Participants in the experimental condition will receive the TIP intervention.
Tonic Immobility Psychoeducation (TIP): TIP is a 45-minute computerized psychoeducation intervention aimed at addressing maladaptive cognitions and emotions associated with TI while using educational and behavioral techniques commonly used in the treatment of trauma-related disorders. Throughout the psychoeducation program vignettes will be presented to clarify concepts and promote participant engagement. In addition, practice exercises and rating scales will be integrated, where applicable, to increase the interactive nature of the program. The following modules will be addressed in the TI psychoeducation intervention: education, myth busting, and behavioral experiments.
|
Health Education Training (HET)
n=21 Participants
Participants in the control condition will receive the HET intervention.
Health Education Training (HET): The Healthy Education Training intervention was developed as a 45-minute online intervention that provides education about physical health habits that can impact mental health, such as diet, exercise, and sleep. This intervention has been used in prior clinical trials to control for effects of general education, general coping techniques, and use of technology. Participants in past clinical trials have reported that HET is engaging and beneficial. However, HET is not expected to have an effect on the main symptom outcomes of the current study (guilt, shame, PTSD symptoms).
|
|---|---|---|
|
Guilt
|
6.6 units on a scale
Standard Deviation 2.94
|
6.85 units on a scale
Standard Deviation 3.86
|
PRIMARY outcome
Timeframe: post-intervention, on Day 1Population: The final sample was comprised of 46 individuals. Of the 51 participants recruited, three participants failed to complete the intervention, as determined at the analysis phase after examining total time spent, and two participants were excluded from analyses due to significantly impairing drug use during the TI experience.
Feelings of shame as measured using the state shame-guilt scale, 8-item (SSGS-8); Value range = 5 to 20 with lower values indicating better outcomes.
Outcome measures
| Measure |
Tonic Immobility Psychoeducation (TIP)
n=25 Participants
Participants in the experimental condition will receive the TIP intervention.
Tonic Immobility Psychoeducation (TIP): TIP is a 45-minute computerized psychoeducation intervention aimed at addressing maladaptive cognitions and emotions associated with TI while using educational and behavioral techniques commonly used in the treatment of trauma-related disorders. Throughout the psychoeducation program vignettes will be presented to clarify concepts and promote participant engagement. In addition, practice exercises and rating scales will be integrated, where applicable, to increase the interactive nature of the program. The following modules will be addressed in the TI psychoeducation intervention: education, myth busting, and behavioral experiments.
|
Health Education Training (HET)
n=21 Participants
Participants in the control condition will receive the HET intervention.
Health Education Training (HET): The Healthy Education Training intervention was developed as a 45-minute online intervention that provides education about physical health habits that can impact mental health, such as diet, exercise, and sleep. This intervention has been used in prior clinical trials to control for effects of general education, general coping techniques, and use of technology. Participants in past clinical trials have reported that HET is engaging and beneficial. However, HET is not expected to have an effect on the main symptom outcomes of the current study (guilt, shame, PTSD symptoms).
|
|---|---|---|
|
Shame
|
6.80 units on a scale
Standard Deviation 2.80
|
6.7 units on a scale
Standard Deviation 3.76
|
Adverse Events
Tonic Immobility Psychoeducation (TIP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Education Training (HET)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place