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

Part of paid clinical trials in San Diego, California.

Sponsor
VA Office of Research and Development
Study ID
NCT06194851
Phase
PHASE2
Status
Recruiting
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Conditions

  • Post-Traumatic Stress Disorder (PTSD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oxytocin nasal spray — DRUG
    Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each bCBCT session.
  • Saline nasal spray — DRUG
    Veteran participants will self-administer 40 IU of the placebo (intranasal saline spray) 30 minutes before the start of each bCBCT session.
  • Brief Cognitive-Behavioral Conjoint Therapy — BEHAVIORAL
    Eight sessions of standardized bCBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.

Study Details

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.

Key Dates

Start date
Oct 28, 2024
Status verified
Apr 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Oxytocin
    Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) weekly. Prior to each session, the veteran participant will self-administer intranasal oxytocin.
  • Placebo Comparator: Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Placebo
    Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) weekly. Prior to each session, the veteran participant will self-administer intranasal placebo solution.

Primary Outcome Measure

PTSD diagnosis and severity change [ Time Frame: Baseline - 6-months post treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA San Diego Healthcare System, San Diego, CASan DiegoCalifornia92161-0002
Leslie A Morland, PsyD
[email protected]
619-497-8406
Leslie A. Morland, PsyD (PRINCIPAL_INVESTIGATOR)

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VA San Diego Healthcare System, San Diego, CA· San Diego, CA

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