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NCT06194851 · ClinicalTrials.gov registry record · Phase 2
Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD
A Phase 2 study of Post Traumatic Stress Disorder (PTSD), sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 240
- Enrollment target
- 1
- Study location
NCT06194851 is a Phase 2 study of Post Traumatic Stress Disorder (PTSD) that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 240 participants, above the 97-participant average among 13 other Post Traumatic Stress Disorder (PTSD) trials with a reported enrollment target (147% higher). The trial reports 1 study location across 1 state.
The verdict
NCT06194851, a Phase 2 study of Post Traumatic Stress Disorder (PTSD), is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 240 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Oxytocin nasal spray
- DRUG Saline nasal spray
- BEHAVIORAL Brief Cognitive-Behavioral Conjoint Therapy
Study Locations (1)
California
- VA San Diego Healthcare System, San Diego, CA - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2024-10-28 |
| Est. Completion | 2028-04-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06194851
The ClinicalTrials.gov registry entry for NCT06194851 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 97-participant average among 13 other Post Traumatic Stress Disorder (PTSD) trials with a reported enrollment target (147% higher). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Post Traumatic Stress Disorder (PTSD) appearing as the primary indexed condition, and to 3 interventions - of which Oxytocin nasal spray is the first listed.
NCT06194851 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06194851 about?
NCT06194851 is a clinical study titled "Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD". 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 PTS...
What is the current status of trial NCT06194851?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 240 participants. The study started on 2024-10-28. Estimated completion is 2028-04-30.
What conditions does trial NCT06194851 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder (PTSD).
What interventions are being tested in trial NCT06194851?
The interventions under investigation include: Oxytocin nasal spray (DRUG), Saline nasal spray (DRUG), Brief Cognitive-Behavioral Conjoint Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT06194851?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06194851 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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