Phase 2
Completed N=20
Brief Cognitive Behavioral Conjoint Therapy for PTSD With Adjunctive Intranasal Oxytocin
Post-Traumatic Stress Disorder · Relational Problems
Source: ClinicalTrials.gov NCT05207436 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcomePrimary: Couples Satisfaction Inventory-32 — 103.6; 87.30 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Couples Satisfaction Inventory-32 |
114.38; 113.0 | — |
| SECONDARY PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5) |
47.78 | — |
| SECONDARY PTSD Checklist for DSM-5 (PCL-5) |
31.22 | — |
| SECONDARY Brief Inventory of Psychosocial Functioning |
32.00; 23.81 | — |
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 160/100 mm Hg)
- Pregnancy, delivery in the past 6 months, or current breastfeeding
- Severe intimate aggression reported by either partner
Data sourced from ClinicalTrials.gov (NCT05207436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.