RCT of Intensive Multi-Couple Therapy for PTSD Versus Relationship Education in Military Couples

Study Overview
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Brief Summary
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The goal of this clinical trial is to test an abbreviated, intensive, multi-couple group version of cognitive-behavioral conjoint therapy for PTSD (AIM-CBCT for PTSD) in an active military and veteran population. The main questions it aims to answer are: Does AIM-CBCT for PTSD improve PTSD symptoms? Does AIM-CBCT for PTSD improve associated symptoms (e.g., depression), romantic partner distress, and couple relationship satisfaction? Participants will participate in a two-day retreat in which they are taught and practice skills to decrease PTSD symptoms and enhance their relationships. Researchers will compare AIM-CBCT for PTSD to the Prevention and Relationship Education Program (PREP) to determine whether it is superior to an evidence-based relationship education curriculum that is also delivered in a two-day multi-couple group format.

Official Title
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Randomized Controlled Trial of Intensive Multi-Couple Therapy for PTSD Versus Relationship Education in Military Couples

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD
* Behavioral: Prevention and Relationship Education Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Service member or veteran and a romantic partner willing to participate. Couple is married or cohabiting for at least 3 months. Couple can be either different or same sex. Service member/veteran diagnosis of PTSD as determined by the CAPS-5 and a CAPS-5 score of 25 or higher. Each partner is at least 18 years old. Both partners able to speak and read English. Exclusion Criteria: Either partner reports current suicidal ideation severe enough to warrant immediate attention Current homicide risk meriting crisis intervention for either partner Current and severe alcohol misuse in either partner in the past 12 weeks and/or warranting immediate intervention Recent (past month) manic episode or psychotic disorder symptoms in either partner Evidence of a moderate or severe traumatic brain injury or other cognitive impairment in either partner Couple is separated or have taken steps to dissolve their relationship Either partner is currently participating in evidence-based treatment for PTSD (e.g., Prolonged Exposure, Cognitive Processing Therapy, Present-Centered Therapy for PTSD, Eye Movement Desensitization and Reprocessing, Cognitive-Behavioral Conjoint Therapy for PTSD, or Structured Approach Therapy). Evidence or admission of severe intimate aggression as indicated by a yes endorsement to the one-question Screen for Conflict Question by either partner occurring within the past 6-months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with parallel group design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD<br>AIM-CBCT for PTSD is an abbreviated, intensive, multi-couple group version of cognitive-behavioral conjoint therapy for PTSD, an evidence-based treatment for PTSD delivered in a conjoint format. | Behavioral: Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD<br>* Approximately 12 hours of programming delivered over 2 consecutive days in a multi-couple group retreat format. Couples are provided with psychoeducation about PTSD and relationship functioning and are taught cognitive and behavioral skills to address the manifestation of PTSD in the couple relationship. Couples will also meet once individually with one of the group leaders 1-2 weeks before the retreat and once 1-2 weeks after the retreat.<br>|
| Active Comparator: Prevention and Relationship Education Program<br>PREP is an evidence-based relationship education program delivered in a multi-couple group format. | Behavioral: Prevention and Relationship Education Program<br>* Approximately 12 hours of programming delivered over 2 consecutive days in a multi-couple group retreat format.The content of PREP and workshop experiences focuses on helping couples communicate effectively, manage conflict without harming their relationship, preserve and act on commitment, improve relationship decision-making, increase understanding of differences between partners, and protect positive connections between partners. Approximately 12 hours of PREP content will be delivered over 2 consecutive days in a multi-couple group retreat format. Couples will also meet once individually with one of the group leaders 1-2 weeks before the retreat and will check in with a member of the study staff 1-2 weeks after the retreat.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician-Administered PTSD Scale for DSM-5 | clinician-rated PTSD symptoms | baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Checklist for DSM-5 | self-reported PTSD symptoms | baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up | 
| Patient Health Questionnaire-9 | self-reported depressive symptoms | baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up | 
| Couples Satisfaction Index-32 | relationship satisfaction | baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD