An interventional study of Transdiagnostic Behavior Therapy and Cognitive Processing Therapy for PTSD in Major Depressive Disorder, Posttraumatic Stress Disorder and Panic Disorder and Agoraphobia, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-06.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
Cognitive behavioral therapy (CBT) is a brief, efficient, and effective treatment for individuals with depressive/anxiety disorders. However, CBT is largely underutilized within the Department of Veterans Affairs due to the cost and burden of trainings necessary to deliver all of the related disorder-specific treatments (DSTs). Transdiagnostic Behavior Therapy (TBT), in contrast, is specifically designed to address numerous distinct disorders within a single protocol in Veterans with depressive/anxiety disorders, including posttraumatic stress disorder. The proposed research seeks to evaluate the efficacy of TBT by assessing psychiatric symptomatology and related impairment outcomes in Veterans with depressive/anxiety disorders via a randomized controlled trial of TBT and existing DSTs in Veterans with major depressive disorder, posttraumatic stress disorder, and panic disorder. Assessments will be completed at pre-, mid-, and post-treatment, and at 6-month follow-up. Process variables also will be investigated.
Objective To examine efficacy of Transdiagnostic Behavior Therapy (TBT) on improving psychiatric symptomatology and related impairments in Veterans with major depressive disorder (MDD), posttraumatic stress disorder (PTSD), and panic disorder and agoraphobia (PD/AG) compared to disorder-specific treatments (DSTs) via a non-inferiority design. Patient satisfaction and predictors of feasibility (attendance and discontinuation) also will be assessed.
Recruitment Strategy and Feasibility of Recruitment Veterans will be recruited through the Primary Care Mental Health Integration, General Outpatient Mental Health, and CBT Clinic programs at the Ralph H. Johnson VAMC and all affiliated VA community-based outpatient clinics. IRB-approved study flyers will be distributed through each clinic/setting. Within these programs, all Veterans reporting symptoms of depression and anxiety meet with a mental health staff member to complete a clinical interview and self-report measures. If Veterans endorse symptoms consistent with a depressive/anxiety disorder, interest in participating in research will be assessed and, if agreeable, the Veteran will be referred to project staff. A research assessment will be completed with the project staff to first complete consent documentation and then assess inclusion/exclusion criteria (with a targeted sample of 306 VAMC patients), including a semi-structured clinical interview and self-report questionnaires focused on psychiatric symptomatology and related impairments (described later). Participants who meet inclusion/exclusion criteria will be randomized into a study condition and will be assigned to a project therapist. Because most VA Medical Center (VAMC) patients who meet study criteria likely will present with multiple depressive/anxiety disorders, principal diagnosis, or the most impairing of the diagnosable disorders, will be used to inform randomization. Principal diagnosis will be determined via diagnostic severity scores in the Anxiety Disorders Interview Schedule-5 (ADIS-5). To balance diagnoses across the two conditions, a stratified random assignment based on principal diagnosis will be used (MDD, PTSD, and PD/AG).
Procedures Eligible VAMC patients will be randomized into one of two treatment conditions: TBT or DSTs. Both treatment conditions will include 12 weekly 45- to 60-minute treatment sessions. The general format of sessions will involve: 1) brief check-in; 2) review of materials from previous sessions; 3) review of homework assignments; 4) overview of new materials and in-session exercises; and 5) assignment of homework for next session. Attendance and homework completion will be recorded.
Randomization Procedures Participants will be randomly assigned (1:1) to one of the two study arms (n = 108 per arm) using a permuted block randomization procedure. Randomization will be stratified by diagnostic group (PTSD, PD/AG, MDD) and block size will be varied to minimize the likelihood of unmasking. After determining eligibility and completing consent and baseline assessment materials, enrolled participants will be assigned to their treatment condition by the Research Project Therapist/Coordinator using a computer-generated randomization scheme.
Transdiagnostic Behavior Therapy TBT was developed as a streamlined protocol to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and positive emotional). 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. 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.
DSTs Control Condition Matching and Assignment 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 (Cognitive Processing Therapy for PTSD), PD/AG (Cognitive Behavioral Therapy for PD/AG), and MDD (Cognitive Behavioral Therapy for MDD). Each of these DSTs have published manuals for administration and have received extensive support in the literature (Barlow, 2014). All three DSTs have been shown to improve comorbid symptomatology and therefore may be a more accurate comparison to TBT as compared to other available DSTs that may have less effect on comorbidity (e.g., applied relaxation for PD/AG).
Assessment of Psychiatric Symptomatology, and Treatment Satisfaction The battery of self-report questionnaires and a diagnostic interview will be completed pre-, mid-, and post-treatment and at the 6-month follow-up to track participants' progression through treatment and maintenance. To reduce the likelihood of missing data, all assessments will be scheduled separately from normal treatment sessions. Assessments of disorder-specific symptomatology, as well general symptoms of the depressive/anxiety disorders and related impairments, were chosen due to the transdiagnostic focus of the proposed study.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's enrollment of 304 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Transdiagnostic Behavior Therapy
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).
Behavioral: Cognitive Processing Therapy for PTSD · Behavioral: Cognitive Behavioral Therapy for MDD · Behavioral: Cognitive Behavioral Therapy for Panic Disorder
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.
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.
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.
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)
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.
Time frame: change from baseline to week 6 to week 12 to 6-month followup
Patient Health Questionnaire - 9 (PHQ-9)
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.
Time frame: change from baseline to week 6 to week 12 to 6-month followup
Panic Disorder Severity Scale (PDSS)
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.
Time frame: change from baseline to week 6 to week 12 to 6-month followup
| Milestone | Transdiagnostic Behavior Therapy | Disorder Specific Therapies |
|---|---|---|
| Started | 153 | 151 |
| Completed | 90 | 87 |
| Not completed | 63 | 64 |
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.
| score on a scale | Transdiagnostic Behavior Therapy | Disorder Specific Therapies |
|---|---|---|
| baseline | 48.0 ± 16.80 | 46.37 ± 16.12 |
| mid-treatment | 42.44 ± 18.83 | 36.95 ± 19.18 |
| post-treatment | 35.00 ± 21.48 | 27.36 ± 19.04 |
| follow-up | 37.40 ± 20.24 | 33.50 ± 20.00 |
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.
| score on a scale | Transdiagnostic Behavior Therapy | Disorder Specific Therapies |
|---|---|---|
| baseline | 17.29 ± 5.66 | 16.28 ± 5.97 |
| mid-treatment | 13.49 ± 6.70 | 12.87 ± 5.79 |
| post-treatment | 11.44 ± 6.82 | 10.32 ± 6.18 |
| follow-up | 13.93 ± 7.31 | 13.84 ± 6.32 |
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.
| score on a scale | Transdiagnostic Behavior Therapy | Disorder Specific Therapies |
|---|---|---|
| baseline | 13.40 ± 6.48 | 12.59 ± 7.58 |
| mid-treatment | 11.53 ± 7.03 | 11.25 ± 7.90 |
| post-treatment | 9.86 ± 7.98 | 6.98 ± 7.05 |
| follow-up | 9.82 ± 7.98 | 8.81 ± 7.34 |
Collected over Through study completion, an average of 9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Transdiagnostic Behavior Therapy | 0/153 (0%) | 1/153 (0.7%) | 13/153 (8.5%) |
| Disorder Specific Therapies | 0/151 (0%) | 2/151 (1.3%) | 8/151 (5.3%) |
| Event | Transdiagnostic Behavior Therapy | Disorder Specific Therapies |
|---|---|---|
| psychiatric hospitalizationPsychiatric disorders | 0/153 | 2/151 |
| EMS call - Emergency VisitPsychiatric disorders | 1/153 | 0/151 |
| Event | Transdiagnostic Behavior Therapy | Disorder Specific Therapies |
|---|---|---|
| Patient cancelled appt due to minor physical health complaints (e.g., stomach virus)Psychiatric disorders | 13/153 | 8/151 |
| Age, Continuous(years) | Transdiagnostic Behavior Therapy | Disorder Specific Therapies | Total |
|---|---|---|---|
| Mean | 46.03 ± 14.34 | 42.57 ± 12.72 | 44.31 ± 13.65 |
| Sex: Female, Male(Participants) | Transdiagnostic Behavior Therapy | Disorder Specific Therapies | Total |
|---|---|---|---|
| Female | 46 | 108 | 154 |
| Male | 107 | 43 | 150 |
| Race (NIH/OMB)(Participants) | Transdiagnostic Behavior Therapy | Disorder Specific Therapies | Total |
|---|---|---|---|
| American Indian or Alaska Native | 3 | 1 | 4 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 53 | 62 | 115 |
| White | 89 | 82 | 171 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 7 | 5 | 12 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Upon consultation with the local VA R\&D and MUSC IRB committees after publication of primary research questions, the de-identified database will be made available to the public via the publishing journal's website (where applicable) as well as on (yet to be determined/selected) research community websites designed for the sharing of scientific findings and data.
Supporting information: Study protocol
Time frame: starting 6 months after publication of the primary outcome papers
Ran from Oct 2020 to primary completion in Jan 2025, 51 months.
Results were first posted in Nov 2025, 10 months after primary completion.
Of 647 non-industry interventional studies with no phase under Depressive Disorder, Major, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 55. This study's 51 months is above that.
Counting every sponsor, half of 687 studies reached it within 33 months; a quarter within 17 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
VA Office of Research and Development →