CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Oxytocin nasal spray +1 moredrug
Likely dose
Oxytocin nasal spray 40 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05207436
NCT05207436Phase 2Completed

Pilot Test of Intranasal Oxytocin as an Enhancer of Brief Couples Therapy for PTSD

San Diego Veterans Healthcare System·interventional·Posted Jan 26, 2022·Updated Jul 10, 2023

In Brief

A Phase 2 clinical trial evaluating Oxytocin nasal spray and Brief Cognitive-Behavioral Conjoint Therapy for Post Traumatic Stress Disorder and Relational Problems. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJan 26, 2022
Enrollment StartJan 17, 2022
Primary CompletionSep 30, 2022
Study CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 4.4 years ago

Interventions

Oxytocin nasal spraydrug

Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each B-CBCT session.

Brief Cognitive-Behavioral Conjoint Therapybehavioral

Eight sessions of standardized B-CBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.