A Phase 2 Study Testing Intranasal Oxytocin Added to Couples Therapy for Veterans With PTSD to Improve Symptoms and Relationships

What this Trial Is About

This research aims to evaluate the effects of Brief Cognitive-Behavioral Conjoint Therapy bCBCT combined with intranasal oxytocin versus bCBCT plus placebo on posttraumatic stress disorder PTSD symptoms and intimate relationship satisfaction in veterans with PTSD and their partners. The study also explores how oxytocin may influence communication, empathy, and trust, which are potential mechanisms behind treatment benefits. The trial uses a randomized, placebo-controlled design and is led by the VA Office of Research and Development. Participants will receive eight weekly sessions of bCBCT, a structured couple therapy targeting both PTSD and relationship functioning. Before each session, the veteran participant will self-administer either 40 IU of intranasal oxytocin or a placebo nasal spray. This manualized therapy involves PTSD education within the relationship context, communication skill-building, behavioral exercises, and cognitive interventions. The study includes a double-blind design where both participants and researchers are unaware of treatment assignment. Throughout the study, veterans and their intimate partners will attend assessment visits at baseline, mid-treatment, post-treatment, and at 3 and 6 months after treatment ends. These assessments will measure PTSD diagnosis and severity as the primary outcome, along with relationship satisfaction and psychosocial functioning as secondary outcomes. Treatment sessions will be audiovideo recorded, and participants will be monitored for adherence and safety. The total participation period includes the treatment phase plus six months of follow-up to evaluate lasting effects.

Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD