RecruitingPhase 2NCT06194851

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

A Randomized Clinical Trial Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD

Sponsor

VA Office of Research and Development

Enrollment

240 participants

Start Date

Oct 28, 2024

Study Type

INTERVENTIONAL

Conditions

Post Traumatic Stress Disorder (PTSD)

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether oxytocin nasal spray — a hormone sometimes called the "bonding hormone" — can enhance the effectiveness of a short course of couples therapy for veterans with PTSD. **You may be eligible if...** - You are a veteran (18 or older) with a current PTSD diagnosis - You have been on stable psychiatric medications for at least 4 weeks (if applicable) - You are married or have been living with a partner for at least 6 months - Your partner (also 18+) is willing to participate in couples therapy with you - You have access to the internet and a private space for virtual sessions **You may NOT be eligible if...** - You are currently receiving other individual trauma-focused therapy or couples therapy - Your partner also has PTSD (per screening) - You are not enrolled at the VA San Diego Healthcare System - You are unwilling to be randomized to a treatment group Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGOxytocin nasal spray

Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.

DRUGSaline nasal spray

Veteran participants will self-administer 40 IU of the placebo (intranasal saline spray) 30 minutes before the start of each bCBCT session.

BEHAVIORALBrief Cognitive-Behavioral Conjoint Therapy

Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.