Trial Outcomes & Findings for Comparing Individual Therapies for Veterans With Depression, PTSD, and Panic Disorder (NCT NCT04293341)
NCT ID: NCT04293341
Last Updated: 2025-11-06
Results Overview
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses DSM-5 criteria PTSD symptoms. Items are scored on a 5-point scale, range from 0 (not at all) to 4 (extremely). The total scale score ranges from 0 to 80 with higher scores associated with more severe symptomatology. 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. The PCL5 will be used to assess symptoms of PTSD.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
304 participants
Primary outcome timeframe
change from baseline to week 6 to week 12 to 6-month followup
Results posted on
2025-11-06
Participant Flow
Participant milestones
| Measure |
Transdiagnostic Behavior Therapy
TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and \[positive\] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders.
Transdiagnostic Behavior Therapy: TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and \[positive\] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders.
|
Disorder Specific Therapies
To provide an evidence-based comparison for the TBT condition, DSTs will be used that are matched to the participant's most severe diagnosis, based upon the average of the ADIS interference and distress scores. If the scores are equivalent for two or more diagnoses, participants will be asked to list which diagnosis/symptoms that they find most impairing. DSTs will be included for each of the three targeted diagnoses, including PTSD (CPT for PTSD), PD/AG (CBT for PD/AG), and MDD (CBT for MDD). Each of these DSTs have published manuals for administration and have received extensive support in the literature (Barlow, 2014).
Cognitive Processing Therapy for PTSD: CPT is a well established evidence-based psychotherapy for PTSD. CPT focuses on teaching patients to evaluate and change the upsetting thoughts that they have had since their trauma.
Cognitive Behavioral Therapy for MDD: CBT for MDD is a well established evidence-based psychotherapy for depression. CBT for MDD focuses teaching patients how to change their behaviors and challenge their negative thoughts to improve their mood.
Cognitive Behavioral Therapy for Panic Disorder: CBT for Panic Disorder is a well established evidence-based psychotherapy. CBT for Panic Disorder focuses teaching patients how to change their behaviors through exposure practices and challenge their anxious thoughts to reduce their experience of panic attacks and avoidance.
|
|---|---|---|
|
Overall Study
STARTED
|
153
|
151
|
|
Overall Study
COMPLETED
|
90
|
87
|
|
Overall Study
NOT COMPLETED
|
63
|
64
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Individual Therapies for Veterans With Depression, PTSD, and Panic Disorder
Baseline characteristics by cohort
| Measure |
Transdiagnostic Behavior Therapy
n=153 Participants
TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and \[positive\] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders.
Transdiagnostic Behavior Therapy: TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and \[positive\] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders.
|
Disorder Specific Therapies
n=151 Participants
To provide an evidence-based comparison for the TBT condition, DSTs will be used that are matched to the participant's most severe diagnosis, based upon the average of the ADIS interference and distress scores. If the scores are equivalent for two or more diagnoses, participants will be asked to list which diagnosis/symptoms that they find most impairing. DSTs will be included for each of the three targeted diagnoses, including PTSD (CPT for PTSD), PD/AG (CBT for PD/AG), and MDD (CBT for MDD). Each of these DSTs have published manuals for administration and have received extensive support in the literature (Barlow, 2014).
Cognitive Processing Therapy for PTSD: CPT is a well established evidence-based psychotherapy for PTSD. CPT focuses on teaching patients to evaluate and change the upsetting thoughts that they have had since their trauma.
Cognitive Behavioral Therapy for MDD: CBT for MDD is a well established evidence-based psychotherapy for depression. CBT for MDD focuses teaching patients how to change their behaviors and challenge their negative thoughts to improve their mood.
Cognitive Behavioral Therapy for Panic Disorder: CBT for Panic Disorder is a well established evidence-based psychotherapy. CBT for Panic Disorder focuses teaching patients how to change their behaviors through exposure practices and challenge their anxious thoughts to reduce their experience of panic attacks and avoidance.
|
Total
n=304 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.03 years
STANDARD_DEVIATION 14.34 • n=49 Participants
|
42.57 years
STANDARD_DEVIATION 12.72 • n=50 Participants
|
44.31 years
STANDARD_DEVIATION 13.65 • n=50 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=49 Participants
|
108 Participants
n=50 Participants
|
154 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=49 Participants
|
43 Participants
n=50 Participants
|
150 Participants
n=50 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=49 Participants
|
1 Participants
n=50 Participants
|
4 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=49 Participants
|
1 Participants
n=50 Participants
|
2 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Black or African American
|
53 Participants
n=49 Participants
|
62 Participants
n=50 Participants
|
115 Participants
n=50 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=49 Participants
|
82 Participants
n=50 Participants
|
171 Participants
n=50 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=49 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=49 Participants
|
5 Participants
n=50 Participants
|
12 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: change from baseline to week 6 to week 12 to 6-month followupPopulation: Numbers varied across time points due to missing data and participant discontinuation of psychotherapy
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses DSM-5 criteria PTSD symptoms. Items are scored on a 5-point scale, range from 0 (not at all) to 4 (extremely). The total scale score ranges from 0 to 80 with higher scores associated with more severe symptomatology. 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. The PCL5 will be used to assess symptoms of PTSD.
Outcome measures
| Measure |
Transdiagnostic Behavior Therapy
n=136 Participants
TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and \[positive\] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders.
Transdiagnostic Behavior Therapy: TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and \[positive\] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders.
|
Disorder Specific Therapies
n=129 Participants
To provide an evidence-based comparison for the TBT condition, DSTs will be used that are matched to the participant's most severe diagnosis, based upon the average of the ADIS interference and distress scores. If the scores are equivalent for two or more diagnoses, participants will be asked to list which diagnosis/symptoms that they find most impairing. DSTs will be included for each of the three targeted diagnoses, including PTSD (CPT for PTSD), PD/AG (CBT for PD/AG), and MDD (CBT for MDD). Each of these DSTs have published manuals for administration and have received extensive support in the literature (Barlow, 2014).
Cognitive Processing Therapy for PTSD: CPT is a well established evidence-based psychotherapy for PTSD. CPT focuses on teaching patients to evaluate and change the upsetting thoughts that they have had since their trauma.
Cognitive Behavioral Therapy for MDD: CBT for MDD is a well established evidence-based psychotherapy for depression. CBT for MDD focuses teaching patients how to change their behaviors and challenge their negative thoughts to improve their mood.
Cognitive Behavioral Therapy for Panic Disorder: CBT for Panic Disorder is a well established evidence-based psychotherapy. CBT for Panic Disorder focuses teaching patients how to change their behaviors through exposure practices and challenge their anxious thoughts to reduce their experience of panic attacks and avoidance.
|
|---|---|---|
|
PTSD Checklist for DSM-5 (PCL-5)
baseline
|
48.0 score on a scale
Standard Deviation 16.80
|
46.37 score on a scale
Standard Deviation 16.12
|
|
PTSD Checklist for DSM-5 (PCL-5)
mid-treatment
|
42.44 score on a scale
Standard Deviation 18.83
|
36.95 score on a scale
Standard Deviation 19.18
|
|
PTSD Checklist for DSM-5 (PCL-5)
post-treatment
|
35.00 score on a scale
Standard Deviation 21.48
|
27.36 score on a scale
Standard Deviation 19.04
|
|
PTSD Checklist for DSM-5 (PCL-5)
follow-up
|
37.40 score on a scale
Standard Deviation 20.24
|
33.50 score on a scale
Standard Deviation 20.00
|
PRIMARY outcome
Timeframe: change from baseline to week 6 to week 12 to 6-month followupPopulation: Numbers varied across time points due to missing data and participant discontinuation of psychotherapy
The Patient Health Questionnaire - 9 (PHQ-9) is a 9-item depression scale derived from the Patient Health Questionnaire to assess the symptoms and diagnosis of depression. Items are scored on a 4-point scale, range from 0 (not at all) to 3 (nearly every day). The total scale score ranges from 0 to 27 with higher scores associated with more severe symptomatology. The PHQ-9 has been shown to have good reliability as well as validity in clinical samples. In addition, the PHQ-9 has been incorporated into standard screenings at the VA. The PHQ-9 will be used to assess symptoms of MDD.
Outcome measures
| Measure |
Transdiagnostic Behavior Therapy
n=141 Participants
TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and \[positive\] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders.
Transdiagnostic Behavior Therapy: TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and \[positive\] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders.
|
Disorder Specific Therapies
n=132 Participants
To provide an evidence-based comparison for the TBT condition, DSTs will be used that are matched to the participant's most severe diagnosis, based upon the average of the ADIS interference and distress scores. If the scores are equivalent for two or more diagnoses, participants will be asked to list which diagnosis/symptoms that they find most impairing. DSTs will be included for each of the three targeted diagnoses, including PTSD (CPT for PTSD), PD/AG (CBT for PD/AG), and MDD (CBT for MDD). Each of these DSTs have published manuals for administration and have received extensive support in the literature (Barlow, 2014).
Cognitive Processing Therapy for PTSD: CPT is a well established evidence-based psychotherapy for PTSD. CPT focuses on teaching patients to evaluate and change the upsetting thoughts that they have had since their trauma.
Cognitive Behavioral Therapy for MDD: CBT for MDD is a well established evidence-based psychotherapy for depression. CBT for MDD focuses teaching patients how to change their behaviors and challenge their negative thoughts to improve their mood.
Cognitive Behavioral Therapy for Panic Disorder: CBT for Panic Disorder is a well established evidence-based psychotherapy. CBT for Panic Disorder focuses teaching patients how to change their behaviors through exposure practices and challenge their anxious thoughts to reduce their experience of panic attacks and avoidance.
|
|---|---|---|
|
Patient Health Questionnaire - 9 (PHQ-9)
baseline
|
17.29 score on a scale
Standard Deviation 5.66
|
16.28 score on a scale
Standard Deviation 5.97
|
|
Patient Health Questionnaire - 9 (PHQ-9)
mid-treatment
|
13.49 score on a scale
Standard Deviation 6.70
|
12.87 score on a scale
Standard Deviation 5.79
|
|
Patient Health Questionnaire - 9 (PHQ-9)
post-treatment
|
11.44 score on a scale
Standard Deviation 6.82
|
10.32 score on a scale
Standard Deviation 6.18
|
|
Patient Health Questionnaire - 9 (PHQ-9)
follow-up
|
13.93 score on a scale
Standard Deviation 7.31
|
13.84 score on a scale
Standard Deviation 6.32
|
PRIMARY outcome
Timeframe: change from baseline to week 6 to week 12 to 6-month followupPopulation: Numbers varied across time points due to missing data and participant discontinuation of psychotherapy
The Panic Disorder Severity Scale (PDSS) is a 7-item scale for the frequency and distress of panic attacks and related symptoms. Items are scored on a 5-point scale, range from 0 (no symptoms) to 4 (extreme symptoms). The total scale score ranges from 0 to 28 with higher scores associated with more severe symptomatology. The scale has demonstrated good internal consistency, test-retest reliability, and sensitivity to change during the course of treatment . The PDSS will be used to assess symptoms of PD/AG.
Outcome measures
| Measure |
Transdiagnostic Behavior Therapy
n=136 Participants
TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and \[positive\] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders.
Transdiagnostic Behavior Therapy: TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and \[positive\] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders.
|
Disorder Specific Therapies
n=125 Participants
To provide an evidence-based comparison for the TBT condition, DSTs will be used that are matched to the participant's most severe diagnosis, based upon the average of the ADIS interference and distress scores. If the scores are equivalent for two or more diagnoses, participants will be asked to list which diagnosis/symptoms that they find most impairing. DSTs will be included for each of the three targeted diagnoses, including PTSD (CPT for PTSD), PD/AG (CBT for PD/AG), and MDD (CBT for MDD). Each of these DSTs have published manuals for administration and have received extensive support in the literature (Barlow, 2014).
Cognitive Processing Therapy for PTSD: CPT is a well established evidence-based psychotherapy for PTSD. CPT focuses on teaching patients to evaluate and change the upsetting thoughts that they have had since their trauma.
Cognitive Behavioral Therapy for MDD: CBT for MDD is a well established evidence-based psychotherapy for depression. CBT for MDD focuses teaching patients how to change their behaviors and challenge their negative thoughts to improve their mood.
Cognitive Behavioral Therapy for Panic Disorder: CBT for Panic Disorder is a well established evidence-based psychotherapy. CBT for Panic Disorder focuses teaching patients how to change their behaviors through exposure practices and challenge their anxious thoughts to reduce their experience of panic attacks and avoidance.
|
|---|---|---|
|
Panic Disorder Severity Scale (PDSS)
baseline
|
13.40 score on a scale
Standard Deviation 6.48
|
12.59 score on a scale
Standard Deviation 7.58
|
|
Panic Disorder Severity Scale (PDSS)
mid-treatment
|
11.53 score on a scale
Standard Deviation 7.03
|
11.25 score on a scale
Standard Deviation 7.90
|
|
Panic Disorder Severity Scale (PDSS)
post-treatment
|
9.86 score on a scale
Standard Deviation 7.98
|
6.98 score on a scale
Standard Deviation 7.05
|
|
Panic Disorder Severity Scale (PDSS)
follow-up
|
9.82 score on a scale
Standard Deviation 7.98
|
8.81 score on a scale
Standard Deviation 7.34
|
Adverse Events
Transdiagnostic Behavior Therapy
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Disorder Specific Therapies
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Transdiagnostic Behavior Therapy
n=153 participants at risk
TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and \[positive\] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders.
Transdiagnostic Behavior Therapy: TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and \[positive\] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders.
|
Disorder Specific Therapies
n=151 participants at risk
To provide an evidence-based comparison for the TBT condition, DSTs will be used that are matched to the participant's most severe diagnosis, based upon the average of the ADIS interference and distress scores. If the scores are equivalent for two or more diagnoses, participants will be asked to list which diagnosis/symptoms that they find most impairing. DSTs will be included for each of the three targeted diagnoses, including PTSD (CPT for PTSD), PD/AG (CBT for PD/AG), and MDD (CBT for MDD). Each of these DSTs have published manuals for administration and have received extensive support in the literature (Barlow, 2014).
Cognitive Processing Therapy for PTSD: CPT is a well established evidence-based psychotherapy for PTSD. CPT focuses on teaching patients to evaluate and change the upsetting thoughts that they have had since their trauma.
Cognitive Behavioral Therapy for MDD: CBT for MDD is a well established evidence-based psychotherapy for depression. CBT for MDD focuses teaching patients how to change their behaviors and challenge their negative thoughts to improve their mood.
Cognitive Behavioral Therapy for Panic Disorder: CBT for Panic Disorder is a well established evidence-based psychotherapy. CBT for Panic Disorder focuses teaching patients how to change their behaviors through exposure practices and challenge their anxious thoughts to reduce their experience of panic attacks and avoidance.
|
|---|---|---|
|
Psychiatric disorders
psychiatric hospitalization
|
0.00%
0/153 • Through study completion, an average of 9 months
|
1.3%
2/151 • Number of events 2 • Through study completion, an average of 9 months
|
|
Psychiatric disorders
EMS call - Emergency Visit
|
0.65%
1/153 • Number of events 1 • Through study completion, an average of 9 months
|
0.00%
0/151 • Through study completion, an average of 9 months
|
Other adverse events
| Measure |
Transdiagnostic Behavior Therapy
n=153 participants at risk
TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and \[positive\] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders.
Transdiagnostic Behavior Therapy: TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and \[positive\] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders.
|
Disorder Specific Therapies
n=151 participants at risk
To provide an evidence-based comparison for the TBT condition, DSTs will be used that are matched to the participant's most severe diagnosis, based upon the average of the ADIS interference and distress scores. If the scores are equivalent for two or more diagnoses, participants will be asked to list which diagnosis/symptoms that they find most impairing. DSTs will be included for each of the three targeted diagnoses, including PTSD (CPT for PTSD), PD/AG (CBT for PD/AG), and MDD (CBT for MDD). Each of these DSTs have published manuals for administration and have received extensive support in the literature (Barlow, 2014).
Cognitive Processing Therapy for PTSD: CPT is a well established evidence-based psychotherapy for PTSD. CPT focuses on teaching patients to evaluate and change the upsetting thoughts that they have had since their trauma.
Cognitive Behavioral Therapy for MDD: CBT for MDD is a well established evidence-based psychotherapy for depression. CBT for MDD focuses teaching patients how to change their behaviors and challenge their negative thoughts to improve their mood.
Cognitive Behavioral Therapy for Panic Disorder: CBT for Panic Disorder is a well established evidence-based psychotherapy. CBT for Panic Disorder focuses teaching patients how to change their behaviors through exposure practices and challenge their anxious thoughts to reduce their experience of panic attacks and avoidance.
|
|---|---|---|
|
Psychiatric disorders
Patient cancelled appt due to minor physical health complaints (e.g., stomach virus)
|
8.5%
13/153 • Number of events 20 • Through study completion, an average of 9 months
|
5.3%
8/151 • Number of events 11 • Through study completion, an average of 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place