Design of a randomized clinical trial of brief couple therapy for PTSD augmented with intranasal oxytocin.
Lauren M Sippel, Tamara R Wachsman, Mary E Kelley...
https://pubmed.ncbi.nlm.nih.gov/38614447Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID06194851
A Randomized Clinical Trial Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD
Led by VA Office of Research and Development · Updated on 2026-05-04
240
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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 audio/video 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.
CONDITIONS
Brief Title
Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Veteran aged 18 or older with a current DSM-5 diagnosis of PTSD at least 3 months after trauma
- On a stable psychoactive medication regimen for at least 4 weeks, if applicable
- Enrolled and eligible to receive care at the Veterans Affairs San Diego Healthcare System
- Intimate partner aged 18 or older willing to participate in the intervention
- Partners can be Veterans but cannot meet criteria for possible PTSD
- Married or cohabitating for at least 6 months
- Willing to be randomized to treatment with bCBCT plus oxytocin or placebo
- Agree to have assessment and treatment sessions audio/video recorded
- Agree not to receive other individual trauma-focused or conjoint PTSD therapy during treatment
- Have capacity for virtual care with internet access and private space
You will not qualify if you...
- Current substance dependence in either partner not in remission for at least 3 months
- Uncontrolled psychotic disorder in either partner
- Imminent suicidality or homicidality in either partner
- Severe cognitive or medical impairment making weekly therapy attendance difficult
- Severe physical or sexual relationship aggression or fear/intimidation in past year
- Severe ongoing medical problems including heart disease, uncontrolled blood pressure, or neuroendocrine disorders
- Positive screen for borderline personality disorder
- Pregnancy, recent delivery, breastfeeding, or ability to become pregnant without effective contraception
- Known allergy to preservatives used in oxytocin nasal spray such as Methylparaben or Propylparaben
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - Eight weeks
Participants and their partners attend eight weekly sessions of Brief Cognitive-Behavioral Conjoint Therapy (bCBCT). Veteran participants self-administer intranasal oxytocin or placebo 30 minutes before each therapy session.
Weekly visits for 8 weeks (in-person)
Follow-up
Duration - 6 months after treatment
Participants complete assessments at mid-treatment, post-treatment, 3 months, and 6 months after completing therapy to monitor PTSD symptoms, relationship satisfaction, and psychosocial functioning.
4 visits (in-person or virtual) over 6 months
Trial Site Locations
Total: 1 location
1
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States, 92161-0002
Actively Recruiting
Loading map...
Research Team
L
Leslie A Morland, PsyD
L
Lauren M Sippel, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here