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

NCT06194851 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

  • Post-Traumatic Stress Disorder (PTSD)

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.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Leslie A. Morland, PsyD · VA San Diego Healthcare System, San Diego, CA

  • Lauren M. Sippel, PhD · VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-28
Primary Completion
2028-09-30
Completion
2028-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06194851 on ClinicalTrials.gov