Comparative Effectiveness of Two Treatments for Veterans With PTSD (NCT02586064) | Clinical Trial Compass
CompletedNot Applicable
Comparative Effectiveness of Two Treatments for Veterans With PTSD
United States115 participantsStarted 2016-09-01
Plain-language summary
Interpersonal problems such as relationship conflict and social isolation are common among Veterans with PTSD and serve as barriers to successful posttraumatic adjustment. The main interventions for PTSD at VA facilities, i.e., Prolonged Exposure, Cognitive Processing Therapy, and Trauma-Focused CBT, do not directly target these relationship difficulties and many Veterans do not complete these treatments. Couple and family approaches for PTSD address relationship problems, but logistical problems make it difficult for couples to attend sessions and these approaches do not involve Veterans who are socially isolated or unmarried. There is accumulating evidence that Interpersonal Psychotherapy (IPT) for PTSD may be effective in reducing symptoms and improving interpersonal functioning. This study, a randomized controlled trial, aims to provide evidence regarding whether IPT for PTSD could be a useful addition to current treatments delivered at the VA.
Who can participate
Age range
18 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:
* Veterans age 18 or older
* Experienced trauma while deployed to a war zone
* Meet DSM-5 criteria for PTSD and a minimum CAPS-5 score of 23
* Have at least one area of relationship dysfunction
* Consent to be randomized
Exclusion Criteria:
* Current severe substance use disorder
* Current psychotic symptoms
* Current mania or un-medicated Bipolar Disorder
* Imminent threat of suicide or homicide
* Victim or perpetrator of severe domestic violence in the past 12 months
* Currently receiving Cognitive Behavioral Therapy for PTSD
* Psychotropic medication start or dosage change within the prior 4 weeks
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.
1This trial compared two specific treatments for PTSD in veterans and also measured interpersonal functioning — do you know which two treatments were being compared, and how they differ from what I'm currently being offered?
2Since this trial is completed, have the results been published, and if so, what did they show about changes in PTSD symptoms and interpersonal relationships for veterans who participated?
3The trial tracked both PTSD symptom severity using the CAPS-5 and interpersonal functioning using the IIP-32 — does that mean one of the treatments may be especially aimed at helping with relationships and social difficulties, not just core PTSD symptoms?
4Given that this study focused specifically on veterans with PTSD, do you think the findings would apply to my situation, and are there any treatments from this trial that are now available outside of a research setting?
5Since this trial has already been completed, would it make more sense for me to pursue one of the treatments that was studied here as a standard option rather than looking for an active trial to join?
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
Change in Clinician Administered PTSD Scale (CAPS-5)
Timeframe: Baseline, week 12 (end of treatment), 3 and 6 months posttreatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks
2
Change in Inventory of Interpersonal Functioning (IIP-32)
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks (end of treatment), 3 and 6 months post-treatment. End of Treatment assessment conducted following the last treatment session participant attended ideally after week 12 but could range from 9 to 20 weeks