Comparing Individual Therapies for Veterans With Depression, PTSD, and Panic Disorder (NCT04293341) | Clinical Trial Compass
CompletedNot Applicable
Comparing Individual Therapies for Veterans With Depression, PTSD, and Panic Disorder
United States304 participantsStarted 2020-10-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants must be Veterans
* Participants must be clearly competent to provide informed consent for research participation
* Participants must meet DSM-5 criteria for panic disorder, major depressive disorder, or posttraumatic stress disorder
* Participants must be 18-80 years old
Exclusion Criteria:
* recent history (\< 2 months) of psychiatric hospitalization or a suicide attempt as documented in their medical record or reported during clinical interview
* acute, severe illness or medical condition that likely will require hospitalization and/or otherwise interfere with study procedures as documented in their medical record (e.g., active chemotherapy/radiation treatment for cancer),
* recent start of new psychiatric medication (\< 4 weeks)
* diagnosis of moderate-to-severe traumatic brain injury in their medical record and/or endorsement of screener questionnaire
* additional comorbid psychiatric diagnoses that were not listed as exclusion criteria are permitted as long as they are considered secondary to the principal diagnosis of MDD, PTSD, or PD/AG as determined by the diagnostic interview
* ineligible Veterans will be referred for non-study-related treatments within mental health at the RHJ VAMC
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PTSD Checklist for DSM-5 (PCL-5)
Timeframe: change from baseline to week 6 to week 12 to 6-month followup
2
Patient Health Questionnaire - 9 (PHQ-9)
Timeframe: change from baseline to week 6 to week 12 to 6-month followup
3
Panic Disorder Severity Scale (PDSS)
Timeframe: change from baseline to week 6 to week 12 to 6-month followup