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RECRUITING
NCT06194851
PHASE2

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

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2024-10-28

Completion Date

2028-04-30

Last Updated

2025-05-29

Healthy Volunteers

No

Interventions

DRUG

Oxytocin nasal spray

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

DRUG

Saline nasal spray

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

BEHAVIORAL

Brief 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.

Locations (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States