Brief Cognitive Behavioral Conjoint Therapy for PTSD With Adjunctive Intranasal Oxytocin
Condition: Post Traumatic Stress Disorder; Relational Problems
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Oxytocin nasal spray; Brief Cognitive-Behavioral Conjoint Therapy
Intervention description: Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each B-CBCT session.; Eight sessions of standardized B-CBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
Intervention MeSH terms: Oxytocin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Post Traumatic Stress Disorder; Oxytocin; Marital Therapy; Couples; Veterans; Telemedicine

Summary:

      In 2019 VA mandated that all Veterans seeking mental health care have access to flexible
      family mental health services in VA (VHA directive 1163.04). This study aims to respond to
      this mandate by further improving an evidence-based PTSD treatment designed to decrease PTSD
      symptoms and improve relationship satisfaction for Veterans and their romantic partners.
      Brief Cognitive-Behavioral Conjoint Therapy (B-CBCT), an 8-session dyadic psychotherapy for
      PTSD, has been found to significantly reduce PTSD symptoms, but the effects of B-CBCT on
      relationship satisfaction are less reliable and robust. Pharmacological augmentation of
      psychotherapy utilizing intranasal oxytocin, a neurohormone that influences mechanisms of
      trauma recovery and social behavior, may help improve relationship satisfaction outcomes. If
      successful, the proposed study will advance knowledge of strategies for improving Veterans'
      quality of life by improving their intimate relationships along with PTSD symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  One member of the couple be a Veteran enrolled in the San Diego VA Healthcare System
             with a Posttraumatic Stress Disorder Checklist-5 score of > 33, indicating a likely
             PTSD diagnosis.

          -  Agree not to receive other individual or conjoint psychotherapy for PTSD during the
             treatment portion of the study

          -  If already on psychoactive medication prior to study referral, Veteran participant
             must remain on a stable psychoactive medication regimen for at least 45 days.

        Exclusion Criteria:

          -  Acute suicidality

          -  Psychosis

          -  Active substance use disorder

          -  Severe ongoing medical problems, including heart disease and neuroendocrinological
             disorders (e.g., diabetes)

          -  Uncontrolled hypotension (systolic blood pressure <100 mm Hg) or hypertension
             (>160/100 mm Hg)

          -  Pregnancy, delivery in the past 6 months, or current breastfeeding

          -  Severe intimate aggression reported by either partner