Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06194851 · ClinicalTrials.gov registry record · Phase 2
Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD
A Phase 2 study of Posttraumatic 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: Recruiting Phase 2 study of Posttraumatic Stress Disorder (PTSD), sponsored by VA Office of Research and Development.
NCT06194851 is a Phase 2 study of Posttraumatic 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 104-participant average among 31 other Posttraumatic Stress Disorder (PTSD) trials with a reported enrollment target (131% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06194851, a Phase 2 study of Posttraumatic 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.
Primary Outcome
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 20-item diagnostic interview administered by trained evaluators to assess PTSD in a participant. Based on DSM-5 diagnostic criteria, evaluators ask about the severity of four PTSD-related symptom clusters: re-experiencing, avoidance, negative alterations in cognition and mood, and alterations in arousal and reactivity. The evaluator rates responses on a 5-point Likert scale (0 = Absent to 4 = Extreme/Incapacitating). Total scores rang
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 |
What NCT06194851 shows while recruiting
NCT06194851 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, above the 104-participant average among 31 other Posttraumatic Stress Disorder (PTSD) trials with a reported enrollment target (131% higher).
The record links to 1 condition, with Posttraumatic Stress Disorder (PTSD) appearing as the primary indexed condition, and to 3 interventions - of which Oxytocin nasal spray is the first listed.
NCT06194851 reports a single indexed study location in 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: Posttraumatic 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.
Learn More About Clinical Trials
Similar trials for Posttraumatic Stress Disorder (PTSD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06194851's enrollment target sits among peer trials
240 3rd of 31 higher than 29 of 31 other Posttraumatic Stress Disorder (PTSD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Posttraumatic Stress Disorder (PTSD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Suvorexant for Treatment of AUD and PTSD
RECRUITING · Phase 2
-
Prazosin and Naltrexone (PaN) Study for Veterans With Alcohol Use Disorders
COMPLETED · Phase 2
-
Oxytocin and Affect Processing in Posttraumatic Stress Disorder
COMPLETED · Phase 2
-
Zonisamide in Addition to E-CPT-C for Veterans With PTSD and Comorbid Alcohol Dependence
COMPLETED · Phase 2
-
Treatment for PTSD and Tinnitus
RECRUITING · NA
-
A Neurosensory Account of Anxiety and Stress (Study 2)
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02855554 · 240 participants · NA
Quantitative Cardiac Parametric Mapping
- NCT03230565 · 240 participants · Phase 4
Continuous Infusions vs Scheduled Bolus Infusions
- NCT03399929 · 240 participants
Traumatic Brain Injury and Stroke Long Term Outcome
- NCT03583710 · 240 participants · Phase 3
Mitotane With or Without Cisplatin and Etoposide After Surgery in Treating Patients With Stage I-III Adrenocortical Cancer With High Risk of Recurrence
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI