NCT06194851 Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD
| NCT ID | NCT06194851 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | VA Office of Research and Development |
| Condition | Post-Traumatic Stress Disorder (PTSD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2024-10-28 |
| Primary Completion | 2028-09-30 |
Trial Parameters
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Brief Summary
Leveraging veterans' intimate relationships during treatment for posttraumatic stress disorder (PTSD) has the potential to concurrently improve PTSD symptoms and relationship quality. Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) is a manualized treatment designed to simultaneously improve PTSD and relationship functioning for couples in which one partner has PTSD. Although efficacious in improving PTSD, the effects of CBCT on relationship satisfaction are small, especially among Veterans. Pharmacological augmentation of bCBCT with intranasal oxytocin, a neurohormone that influences mechanisms of trauma recovery and social behavior, may help improve the efficacy of bCBCT. The purpose of this randomized placebo-controlled trial is to compare the clinical and functional outcomes of bCBCT augmented with intranasal oxytocin (bCBCT + OT) versus bCBCT plus placebo (bCBCT + PL). The investigators will also explore potential mechanisms of action: communication, empathy, and trust.
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for Veteran: 1. Be a Veteran (age 18 or older) with a current DSM-5 diagnosis of PTSD (as assessed by the CAPS-5 with a minimum severity score of 25) no less than 3 months after the index trauma occurred (to allow for potential natural recovery) 2. Be on a stable psychoactive medication regimen for at least 4 weeks (if applicable) 3. Be enrolled and eligible to receive care at the VASDHS Inclusion criteria for Partner: 4. Be an intimate partner (age 18 or older) who is willing to participate in the intervention (partners can also be Veterans but cannot meet criteria for possible PTSD per the PCL-5) Inclusion criteria for Veteran and Partner: 5. Be married, or cohabitating for at least 6 months 6. Willing to be randomized into either treatment condition (bCBCT + OT or bCBCT + PL) 7. Agree to have assessment and treatment sessions audio/video recorded 8. Agree not to receive other individual trauma-focused psychotherapy for PTSD or any form of conjo
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