Trial Outcomes & Findings for Novel Neural Circuit Biomarkers of Major Depression Response to CCBT (NCT NCT03096886)
NCT ID: NCT03096886
Last Updated: 2024-12-05
Results Overview
Compare baseline resting state functional connectivity and task-induced activity between MDD (early and late CCBT combined) and controls. The connectivity values were Z-normalized Pearson's r values. Specifically, time series values were averaged across all voxels within each given Region Of Interest (ROI) (Left Dorsolateral Prefrontal Cortex and Subgenual Anterior Cingulate Cortex). For each study visit for each participant, the resulting region-wise time series values were then correlated with those from another ROI using a Pearson correlation. This correlation coefficient was then Z-normalized to yield the connectivity value. Improvement was defined as connectivity that is closer to negative (less positive). There is no relevant clinical threshold.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
132 participants
Primary outcome timeframe
Baseline
Results posted on
2024-12-05
Participant Flow
Participant milestones
| Measure |
Early CCBT
Intervention: Computer-Augmented Cognitive Behavioral Therapy
Half of participants presenting with MDD will be randomized to receive 8 weeks of Computer-Augmented Cognitive Behavior Therapy (CCBT) immediately after completing pre-treatment assessments; imaging data will be collected pre- and post-treatment.
Computer-Augmented Cognitive Behavioral Therapy: The model of CCBT, "Good Days Ahead" (GDA) will be utilized, it has been found that it is not inferior to CBT in MDD treatment efficacy. CCBT participants will complete 9 modules of the GDA program, including 240 minutes of computer training; participants will also meet with a therapist on 6 occasions for a total of 180 minutes of clinician administered cognitive behavioral therapy.
|
Late CCBT
Intervention: Waitlist followed by Computer-Augmented Cognitive Behavioral Therapy
Half of participants presenting with MDD will be randomized to be waitlisted for up to 4 weeks and will receive CCBT within 4 weeks; imaging data will also be collected pre--treatment, following waitlist, and post-treatment of CCBT.
This arm will serve as the equivalent of a "placebo comparator" arm during the waitlist; and then as an experimental arm when receiving 8 weeks of CCBT treatment.
Computer-Augmented Cognitive Behavioral Therapy: The model of CCBT, "Good Days Ahead" (GDA) will be utilized, it has been found that it is not inferior to CBT in MDD treatment efficacy. CCBT participants will complete 9 modules of the GDA program, including 240 minutes of computer training; participants will also meet with a therapist on 6 occasions for a total of 180 minutes of clinician administered cognitive behavioral therapy.
|
Matched Comparison
No Intervention: Matched Comparison
Healthy controls will act as a matched comparator. Participants will complete pre-treatment assessments and imaging.
|
|---|---|---|---|
|
Overall Study
STARTED
|
38
|
44
|
50
|
|
Overall Study
COMPLETED
|
30
|
30
|
40
|
|
Overall Study
NOT COMPLETED
|
8
|
14
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Novel Neural Circuit Biomarkers of Major Depression Response to CCBT
Baseline characteristics by cohort
| Measure |
Early CCBT
n=30 Participants
Intervention: Computer-Augmented Cognitive Behavioral Therapy
Half of participants presenting with MDD will be randomized to receive 8 weeks of Computer-Augmented Cognitive Behavior Therapy (CCBT) immediately after completing pre-treatment assessments; imaging data will be collected pre- and post-treatment.
Computer-Augmented Cognitive Behavioral Therapy: The model of CCBT, "Good Days Ahead" (GDA) will be utilized, it has been found that it is not inferior to CBT in MDD treatment efficacy. CCBT participants will complete 9 modules of the GDA program, including 240 minutes of computer training; participants will also meet with a therapist on 6 occasions for a total of 180 minutes of clinician administered cognitive behavioral therapy.
|
Late CCBT
n=30 Participants
Intervention: Waitlist followed by Computer-Augmented Cognitive Behavioral Therapy
Half of participants presenting with MDD will be randomized to be waitlisted for up to 4 weeks and will receive CCBT within 4 weeks; imaging data will also be collected pre--treatment, following waitlist, and post-treatment of CCBT.
This arm will serve as the equivalent of a "placebo comparator" arm during the waitlist; and then as an experimental arm when receiving 8 weeks of CCBT treatment.
Computer-Augmented Cognitive Behavioral Therapy: The model of CCBT, "Good Days Ahead" (GDA) will be utilized, it has been found that it is not inferior to CBT in MDD treatment efficacy. CCBT participants will complete 9 modules of the GDA program, including 240 minutes of computer training; participants will also meet with a therapist on 6 occasions for a total of 180 minutes of clinician administered cognitive behavioral therapy.
|
Matched Comparison
n=40 Participants
No Intervention: Matched Comparison
Healthy controls will act as a matched comparator. Participants will complete pre-treatment assessments and imaging.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
28.5 years
STANDARD_DEVIATION 7.98 • n=5 Participants
|
29.1 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
27.7 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
28.4 years
STANDARD_DEVIATION 8.45 • n=4 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
90 Participants
n=4 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
17 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 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
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
40 participants
n=5 Participants
|
100 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: BaselineCompare baseline resting state functional connectivity and task-induced activity between MDD (early and late CCBT combined) and controls. The connectivity values were Z-normalized Pearson's r values. Specifically, time series values were averaged across all voxels within each given Region Of Interest (ROI) (Left Dorsolateral Prefrontal Cortex and Subgenual Anterior Cingulate Cortex). For each study visit for each participant, the resulting region-wise time series values were then correlated with those from another ROI using a Pearson correlation. This correlation coefficient was then Z-normalized to yield the connectivity value. Improvement was defined as connectivity that is closer to negative (less positive). There is no relevant clinical threshold.
Outcome measures
| Measure |
Early CCBT
n=36 Participants
Intervention: Computer-Augmented Cognitive Behavioral Therapy
Half of participants presenting with MDD will be randomized to receive 8 weeks of Computer-Augmented Cognitive Behavior Therapy (CCBT) immediately after completing pre-treatment assessments; imaging data will be collected pre- and post-treatment.
Computer-Augmented Cognitive Behavioral Therapy: The model of CCBT, "Good Days Ahead" (GDA) will be utilized, it has been found that it is not inferior to CBT in MDD treatment efficacy. CCBT participants will complete 9 modules of the GDA program, including 240 minutes of computer training; participants will also meet with a therapist on 6 occasions for a total of 180 minutes of clinician administered cognitive behavioral therapy.
|
Late CCBT
n=36 Participants
Intervention: Waitlist followed by Computer-Augmented Cognitive Behavioral Therapy
Half of participants presenting with MDD will be randomized to be waitlisted for up to 4 weeks and will receive CCBT within 4 weeks; imaging data will also be collected pre--treatment, following waitlist, and post-treatment of CCBT.
This arm will serve as the equivalent of a "placebo comparator" arm during the waitlist; and then as an experimental arm when receiving 8 weeks of CCBT treatment.
Computer-Augmented Cognitive Behavioral Therapy: The model of CCBT, "Good Days Ahead" (GDA) will be utilized, it has been found that it is not inferior to CBT in MDD treatment efficacy. CCBT participants will complete 9 modules of the GDA program, including 240 minutes of computer training; participants will also meet with a therapist on 6 occasions for a total of 180 minutes of clinician administered cognitive behavioral therapy.
|
Matched Comparison
n=40 Participants
No Intervention: Matched Comparison
Healthy controls will act as a matched comparator. Participants will complete pre-treatment assessments and imaging.
|
|---|---|---|---|
|
Resting State Functional Connectivity: MDD vs Controls
|
.51 Z normalized correlation
Standard Deviation .21
|
.65 Z normalized correlation
Standard Deviation .21
|
.54 Z normalized correlation
Standard Deviation .17
|
SECONDARY outcome
Timeframe: Week 8Population: This data was only collected from the Early CCBT group and the Late CCBT group. It was not collected from the Matched Comparison group.
Assess CCBT treatment effects on resting state functional connectivity and task-induced activity in MDD comparing Immediate CCBT treatment vs Waitlist followed by CCBT at 8 weeks. The connectivity values were Z-normalized Pearson's r values. Specifically, time series values were averaged across all voxels within each given Region Of Interest (ROI) (Left Dorsolateral Prefrontal Cortex and Subgenual Anterior Cingulate Cortex). For each study visit for each participant, the resulting region-wise time series values were then correlated with those from another ROI using a Pearson correlation. This correlation coefficient was then Z-normalized to yield the connectivity value. Improvement was defined as connectivity that is closer to negative (less positive). There is no relevant clinical threshold.
Outcome measures
| Measure |
Early CCBT
n=30 Participants
Intervention: Computer-Augmented Cognitive Behavioral Therapy
Half of participants presenting with MDD will be randomized to receive 8 weeks of Computer-Augmented Cognitive Behavior Therapy (CCBT) immediately after completing pre-treatment assessments; imaging data will be collected pre- and post-treatment.
Computer-Augmented Cognitive Behavioral Therapy: The model of CCBT, "Good Days Ahead" (GDA) will be utilized, it has been found that it is not inferior to CBT in MDD treatment efficacy. CCBT participants will complete 9 modules of the GDA program, including 240 minutes of computer training; participants will also meet with a therapist on 6 occasions for a total of 180 minutes of clinician administered cognitive behavioral therapy.
|
Late CCBT
n=32 Participants
Intervention: Waitlist followed by Computer-Augmented Cognitive Behavioral Therapy
Half of participants presenting with MDD will be randomized to be waitlisted for up to 4 weeks and will receive CCBT within 4 weeks; imaging data will also be collected pre--treatment, following waitlist, and post-treatment of CCBT.
This arm will serve as the equivalent of a "placebo comparator" arm during the waitlist; and then as an experimental arm when receiving 8 weeks of CCBT treatment.
Computer-Augmented Cognitive Behavioral Therapy: The model of CCBT, "Good Days Ahead" (GDA) will be utilized, it has been found that it is not inferior to CBT in MDD treatment efficacy. CCBT participants will complete 9 modules of the GDA program, including 240 minutes of computer training; participants will also meet with a therapist on 6 occasions for a total of 180 minutes of clinician administered cognitive behavioral therapy.
|
Matched Comparison
No Intervention: Matched Comparison
Healthy controls will act as a matched comparator. Participants will complete pre-treatment assessments and imaging.
|
|---|---|---|---|
|
Resting State Functional Connectivity: Immediate CCBT vs Waitlist Followed by CCBT
|
.46 Z normalized correlation
Standard Deviation .17
|
.57 Z normalized correlation
Standard Deviation .18
|
—
|
Adverse Events
Early CCBT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Late CCBT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Matched Comparison
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