Trial Outcomes & Findings for Comparing Group Therapies for Veterans With Depression and PTSD (NCT NCT03979040)
NCT ID: NCT03979040
Last Updated: 2024-07-03
Results Overview
The DASS-Depression is a 7-item measure designed to assess dysphoric mood. Items are rated on a 4-point Likert scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), and summed to compute the total scale that ranges from 0 to 21. Higher scores are indicative of greater symptom severity. The factor structure, reliability, and validity of the subscales have been supported in the literature.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
294 participants
Primary outcome timeframe
change from baseline to 6-month follow-up
Results posted on
2024-07-03
Participant Flow
294 participants completed the intake procedures and consent documentation. Of the 294, 243 participants met study inclusion/exclusion criteria and were enrolled and randomized to study condition
Participant milestones
| Measure |
Group Transdiagnostic Behavior Therapy
TBT was developed to address transdiagnostic avoidance via four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders. Per protocol, the first six sessions of TBT are designed to educate on, prepare for, and practice the four different types of exposure techniques. The next five sessions are focused on practicing and refining exposure practices as participants work through their lists of avoided situations/sensation/thoughts. The final session reviews treatment progress and relapse prevention strategies.
|
Group Disorder-Specific Therapy (G-DSTs)
To provide an evidence-based comparison for the G-TBT condition, G-DSTs will be used that are matched to the participant's principal diagnosis. G-DSTs included groups for PTSD (Cognitive Processing Therapy for PTSD) and MDD (CBT-Depression). Each of these G-DSTs have published manuals for administration and have received extensive support in the literature.
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
118
|
|
Overall Study
COMPLETED
|
69
|
46
|
|
Overall Study
NOT COMPLETED
|
56
|
72
|
Reasons for withdrawal
| Measure |
Group Transdiagnostic Behavior Therapy
TBT was developed to address transdiagnostic avoidance via four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders. Per protocol, the first six sessions of TBT are designed to educate on, prepare for, and practice the four different types of exposure techniques. The next five sessions are focused on practicing and refining exposure practices as participants work through their lists of avoided situations/sensation/thoughts. The final session reviews treatment progress and relapse prevention strategies.
|
Group Disorder-Specific Therapy (G-DSTs)
To provide an evidence-based comparison for the G-TBT condition, G-DSTs will be used that are matched to the participant's principal diagnosis. G-DSTs included groups for PTSD (Cognitive Processing Therapy for PTSD) and MDD (CBT-Depression). Each of these G-DSTs have published manuals for administration and have received extensive support in the literature.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
24
|
32
|
|
Overall Study
randomized but never started treatment
|
32
|
39
|
|
Overall Study
withdrawn by study team due to poor fit/lack of efficacy
|
0
|
1
|
Baseline Characteristics
A number of participants were randomized based on completing consent documents and diagnostic assessment (inclusion/exclusion criteria), but failed to mail in their baseline symptom measures.
Baseline characteristics by cohort
| Measure |
Group Transdiagnostic Behavior Therapy
n=125 Participants
TBT was developed to address transdiagnostic avoidance via four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders. Per protocol, the first six sessions of TBT are designed to educate on, prepare for, and practice the four different types of exposure techniques. The next five sessions are focused on practicing and refining exposure practices as participants work through their lists of avoided situations/sensation/thoughts. The final session reviews treatment progress and relapse prevention strategies.
|
Group Disorder-Specific Therapy (G-DSTs)
n=118 Participants
To provide an evidence-based comparison for the G-TBT condition, G-DSTs will be used that are matched to the participant's principal diagnosis. G-DSTs included groups for PTSD (Cognitive Processing Therapy for PTSD) and MDD (CBT-Depression). Each of these G-DSTs have published manuals for administration and have received extensive support in the literature.
|
Total
n=243 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.0 years
STANDARD_DEVIATION 12.4 • n=125 Participants
|
45.7 years
STANDARD_DEVIATION 14.0 • n=118 Participants
|
45.9 years
STANDARD_DEVIATION 13.1 • n=243 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=125 Participants
|
32 Participants
n=118 Participants
|
71 Participants
n=243 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=125 Participants
|
86 Participants
n=118 Participants
|
172 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
58 Participants
n=125 Participants
|
57 Participants
n=118 Participants
|
115 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Black, non-Hispanic
|
56 Participants
n=125 Participants
|
48 Participants
n=118 Participants
|
104 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Asian American
|
1 Participants
n=125 Participants
|
2 Participants
n=118 Participants
|
3 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
6 Participants
n=125 Participants
|
9 Participants
n=118 Participants
|
15 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Native American
|
2 Participants
n=125 Participants
|
0 Participants
n=118 Participants
|
2 Participants
n=243 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=125 Participants
|
2 Participants
n=118 Participants
|
4 Participants
n=243 Participants
|
|
Depression Anxiety Stress Scales - Depression (DASS-D)
|
10.8 units on a scale
STANDARD_DEVIATION 5.3 • n=81 Participants • A number of participants were randomized based on completing consent documents and diagnostic assessment (inclusion/exclusion criteria), but failed to mail in their baseline symptom measures.
|
12.0 units on a scale
STANDARD_DEVIATION 5.5 • n=78 Participants • A number of participants were randomized based on completing consent documents and diagnostic assessment (inclusion/exclusion criteria), but failed to mail in their baseline symptom measures.
|
11.4 units on a scale
STANDARD_DEVIATION 5.4 • n=159 Participants • A number of participants were randomized based on completing consent documents and diagnostic assessment (inclusion/exclusion criteria), but failed to mail in their baseline symptom measures.
|
|
PTSD Checklist for DSM-5 (PCL)
|
43.7 units on a scale
STANDARD_DEVIATION 17.2 • n=80 Participants • A number of participants were randomized based on completing consent documents and diagnostic assessment (inclusion/exclusion criteria), but failed to mail in their baseline symptom measures.
|
46.2 units on a scale
STANDARD_DEVIATION 14.2 • n=78 Participants • A number of participants were randomized based on completing consent documents and diagnostic assessment (inclusion/exclusion criteria), but failed to mail in their baseline symptom measures.
|
44.9 units on a scale
STANDARD_DEVIATION 15.8 • n=158 Participants • A number of participants were randomized based on completing consent documents and diagnostic assessment (inclusion/exclusion criteria), but failed to mail in their baseline symptom measures.
|
|
Illness Intrusiveness Ratings Scale (IIRS)
|
60.4 units on a scale
STANDARD_DEVIATION 14.6 • n=81 Participants • A number of participants were randomized based on completing consent documents and diagnostic assessment (inclusion/exclusion criteria), but failed to mail in their baseline symptom measures.
|
61.4 units on a scale
STANDARD_DEVIATION 16.5 • n=78 Participants • A number of participants were randomized based on completing consent documents and diagnostic assessment (inclusion/exclusion criteria), but failed to mail in their baseline symptom measures.
|
60.9 units on a scale
STANDARD_DEVIATION 15.5 • n=159 Participants • A number of participants were randomized based on completing consent documents and diagnostic assessment (inclusion/exclusion criteria), but failed to mail in their baseline symptom measures.
|
PRIMARY outcome
Timeframe: change from baseline to 6-month follow-upPopulation: The total number of participants analyzed is inconsistent from the total number of participants reported in the Participant Flow due to missing data - participants failed to return self-report questionnaire packets.
The DASS-Depression is a 7-item measure designed to assess dysphoric mood. Items are rated on a 4-point Likert scale, ranging from 0 (did not apply to me at all) to 3 (applied to me very much or most of the time), and summed to compute the total scale that ranges from 0 to 21. Higher scores are indicative of greater symptom severity. The factor structure, reliability, and validity of the subscales have been supported in the literature.
Outcome measures
| Measure |
Group Transdiagnostic Behavior Therapy
n=51 Participants
TBT was developed to address transdiagnostic avoidance via four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders. Per protocol, the first six sessions of TBT are designed to educate on, prepare for, and practice the four different types of exposure techniques. The next five sessions are focused on practicing and refining exposure practices as participants work through their lists of avoided situations/sensation/thoughts. The final session reviews treatment progress and relapse prevention strategies.
|
Group Disorder-Specific Therapy (G-DSTs)
n=35 Participants
To provide an evidence-based comparison for the G-TBT condition, G-DSTs will be used that are matched to the participant's principal diagnosis. G-DSTs included groups for PTSD (Cognitive Processing Therapy for PTSD) and MDD (CBT-Depression). Each of these G-DSTs have published manuals for administration and have received extensive support in the literature.
|
|---|---|---|
|
Depression Anxiety Stress Scale (DASS-Depression)
mid-treatment (week 6)
|
10.6 units on a scale
Standard Deviation 5.8
|
11.0 units on a scale
Standard Deviation 5.9
|
|
Depression Anxiety Stress Scale (DASS-Depression)
post-treatment (week 12)
|
8.8 units on a scale
Standard Deviation 6.1
|
8.1 units on a scale
Standard Deviation 5.9
|
|
Depression Anxiety Stress Scale (DASS-Depression)
follow-up (6 months post-treatment)
|
8.5 units on a scale
Standard Deviation 6.9
|
9.9 units on a scale
Standard Deviation 6.4
|
PRIMARY outcome
Timeframe: change from baseline to 6-month follow-upPopulation: The total number of participants analyzed is inconsistent from the total number of participants reported in the Participant Flow due to missing data - participants failed to return self-report questionnaire packets.
The IIRS is a 13-item questionnaire that assesses the extent to which a disease interferes with important domains of life, including health, diet, work, and several others. Each item is rated on a 7-point Likert scale, ranging from 1 (not very much) to 7 (very much). Items are summed to create the total score (ranging from 1 to 91), with higher scores indicative of greater impairment. The IIRS has been shown to have high internal consistency in the previous literature.
Outcome measures
| Measure |
Group Transdiagnostic Behavior Therapy
n=51 Participants
TBT was developed to address transdiagnostic avoidance via four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders. Per protocol, the first six sessions of TBT are designed to educate on, prepare for, and practice the four different types of exposure techniques. The next five sessions are focused on practicing and refining exposure practices as participants work through their lists of avoided situations/sensation/thoughts. The final session reviews treatment progress and relapse prevention strategies.
|
Group Disorder-Specific Therapy (G-DSTs)
n=35 Participants
To provide an evidence-based comparison for the G-TBT condition, G-DSTs will be used that are matched to the participant's principal diagnosis. G-DSTs included groups for PTSD (Cognitive Processing Therapy for PTSD) and MDD (CBT-Depression). Each of these G-DSTs have published manuals for administration and have received extensive support in the literature.
|
|---|---|---|
|
Illness Intrusiveness Ratings Scale (IIRS)
mid-treatment (week 6)
|
62.6 units on a scale
Standard Deviation 17.8
|
59.3 units on a scale
Standard Deviation 15.5
|
|
Illness Intrusiveness Ratings Scale (IIRS)
post-treatment (week 12)
|
59.0 units on a scale
Standard Deviation 18.1
|
52 units on a scale
Standard Deviation 19.2
|
|
Illness Intrusiveness Ratings Scale (IIRS)
follow-up (6-months post-treatment)
|
53.8 units on a scale
Standard Deviation 23.8
|
52.9 units on a scale
Standard Deviation 22.7
|
PRIMARY outcome
Timeframe: change from baseline to 6-month follow-upPopulation: The total number of participants analyzed is inconsistent from the total number of participants reported in the Participant Flow due to missing data - participants failed to return self-report questionnaire packets.
The PCL-5 is a 20-item self-report measure that assesses DSM-5 criteria PTSD symptoms. Items are rated on a 5-point Likert scale, ranging from 0 (not at all) to 4 (extremely), and summed to compute the total scale that ranges from 0 to 80. Higher scores are indicative of greater symptom severity. Previous versions of the PCL have been shown to have excellent internal consistency and excellent test-retest reliability in veterans. In addition, the PCL-5 has been incorporated into standard assessment for PTSD at the VA.
Outcome measures
| Measure |
Group Transdiagnostic Behavior Therapy
n=50 Participants
TBT was developed to address transdiagnostic avoidance via four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders. Per protocol, the first six sessions of TBT are designed to educate on, prepare for, and practice the four different types of exposure techniques. The next five sessions are focused on practicing and refining exposure practices as participants work through their lists of avoided situations/sensation/thoughts. The final session reviews treatment progress and relapse prevention strategies.
|
Group Disorder-Specific Therapy (G-DSTs)
n=34 Participants
To provide an evidence-based comparison for the G-TBT condition, G-DSTs will be used that are matched to the participant's principal diagnosis. G-DSTs included groups for PTSD (Cognitive Processing Therapy for PTSD) and MDD (CBT-Depression). Each of these G-DSTs have published manuals for administration and have received extensive support in the literature.
|
|---|---|---|
|
PTSD Checklist for DSM-5 (PCL-5)
mid-treatment (week 6)
|
43.4 units on a scale
Standard Deviation 19
|
40.0 units on a scale
Standard Deviation 15.5
|
|
PTSD Checklist for DSM-5 (PCL-5)
post-treatment (week 12)
|
40.3 units on a scale
Standard Deviation 18.3
|
33.9 units on a scale
Standard Deviation 18.5
|
|
PTSD Checklist for DSM-5 (PCL-5)
follow-up (6-month post-treatment)
|
36.9 units on a scale
Standard Deviation 20.5
|
35.9 units on a scale
Standard Deviation 20.6
|
Adverse Events
Group Transdiagnostic Behavior Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group Disorder-Specific Therapy (G-DSTs)
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
Dr. Nik Allan - Study Statistician
VA Finger Lakes Health Care System
Phone: (850) 274-0567
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place