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

D4776-R

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.

2024-09-02

2028-04-30

2028-04-30

Not yet recruiting

Early phase I

240

Inclusion Criteria: Inclusion criteria for Veterans 1. Be a veteran (age 18 or older) with a current DSM-5 diagnosis of PTSD (as assessed by the CAPS-5) no less than 3 months after the index trauma occurred (to allow for potential natural recovery) 2. Be on a stable psychoactive medication regimen for at least 2 months (if eligible) 3. Veteran must be enrolled and eligible to receive care at the VASDHS Inclusion criteria for Partners 1.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) Inclusion criteria for Veterans and Partner dyads 1. Be married, or cohabitating for at least 6 months 2. Willing to be randomized into both treatment conditions 3. Agree to have assessment and treatment sessions audio recorded 4. Agree not to receive other individual or conjoint trauma-focused psychotherapy for PTSD during the treatment portion of the study 5. Have the capacity to participate in virtual care (access to internet via DSL or a cable provider, private space) Exclusion Criteria: Exclusion criteria for Veterans and Partners 1. 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) and Drug Abuse Screening Test (DAST) 2. Any current uncontrolled psychotic disorder in either member of the couple as assessed by the SCID-5 psychosis module 3. Positive screen (7+) for borderline personality disorder (BPD) in either member of the couple as assessed by the MacLean Screening Instrument for BPD 4. Imminent suicidality or homicidality in either member of the couple 5. Any severe cognitive or medical impairment in either member of the couple making it difficult to regularly attend weekly couple's psychotherapy 6. 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 Exclusion criteria for Veterans with PTSD: 1. Severe ongoing medical problems, including heart disease and neuroendocrinological disorders (e.g., diabetes) 2. Uncontrolled hypotension (systolic blood pressure \<100 mm Hg) or hypertension (BP \>160/100 mm Hg) as assessed by self-report and verified with VA chart review (in absence of chart documentation in past month, participant will be sent digital BP device and cuff to verify BP stability during video monitoring) 3. Pregnancy, delivery in the past 6 months, or current breastfeeding

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2024-05-10