Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD (NCT06194851) | Clinical Trial Compass
RecruitingPhase 2
Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD
United States240 participantsStarted 2024-10-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Be a Veteran (age 18 or older) with a current DSM-5 diagnosis of PTSD (as assessed by the CAPS-5 with a minimum severity score of 25) no less than 3 months after the index trauma occurred (to allow for potential natural recovery)
✓. Be on a stable psychoactive medication regimen for at least 4 weeks (if applicable)
✓. Be enrolled and eligible to receive care at the VASDHS
✓. Be an intimate partner (age 18 or older) who is willing to participate in the intervention (partners can also be Veterans but cannot meet criteria for possible PTSD per the PCL-5)
✓. Be married, or cohabitating for at least 6 months
✓. Willing to be randomized into either treatment condition (bCBCT + OT or bCBCT + PL)
✓. Agree to have assessment and treatment sessions audio/video recorded
✓. Agree not to receive other individual trauma-focused psychotherapy for PTSD or any form of conjoint therapy during the treatment portion of the study
✕0. Current substance dependence in either member of the couple not in remission for at least 3 months, as assessed by the Alcohol Use Disorders Identification Test (AUDIT)74 and Drug Abuse Screening Test (DAST)75
✕1. Any current uncontrolled psychotic disorder in either member of the couple as assessed by positive screen on the Prime Screen-Revised (PS-R). Exclusion to be determined following case consult by PI or other clinician.
✕2. Imminent suicidality or homicidality in either member of the couple (e.g., C-SSRS)
✕3. Any severe cognitive or medical impairment in either member of the couple making it difficult to regularly attend weekly couples psychotherapy
✕4. Any perpetration of severe physical or sexual relationship aggression (as assessed by the CTS-2) or fear/intimidation (3-item IPV screen, Couples Questionnaire) in the past year
✕5. Severe ongoing medical problems, including heart disease, uncontrolled hypotension (systolic blood pressure \<100 mm Hg) or hypertension (systolic BP \>130 or diastolic BP \> 80 mm Hg), and neuroendocrinological disorders (e.g., diabetes). Exclusion to be determined in collaboration with study physician following completion of physician's one-on-one appointment with Veteran and review of all relevant information (e.g., risk factors, health history, concomitant medications, etc.) from Veteran's VA medical record and study screening/assessment processes including selfreport measures and blood pressure measurement. Additionally, Veterans for whom the study physician has elevated concern, will be asked to attend an in-person visit at a VA medical center, clinic, or the Veterans Medical Research Foundation before enrollment.
✕6. Positive screen (7+) for borderline personality disorder (BPD) as assessed by the MacLean Screening Instrument for BPD76. Exclusion to be determined following case consult by PI or other clinician.
✕7. Pregnancy, delivery in the past 6 months, current breastfeeding, or the ability to become pregnant while not practicing an effective method of contraception. If able to become pregnant, Veteran must have a highly sensitive negative urine pregnancy test verified visually via telehealth or in-person at the Veterans Medical Research Foundation by research staff at study entry and prior to each medication administration during treatment. Veteran must verbally confirm that they completed the test themselves that day. Veteran must also agree to use an effective birth control method from study entry until conclusion of treatment to prevent pregnancy. The ability to become pregnant is defined as: assigned female at birth, fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.