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Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Oxytocin for Post-Traumatic Stress Disorder (CBCT-OT RCT Trial)

Phase 2

Waitlist Available

Led By Leslie A. Morland, PsyD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Agree not to receive other individual or conjoint trauma-focused psychotherapy for PTSD during the treatment portion of the study

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline - 6-months post treatment

Awards & highlights

CBCT-OT RCT Trial Summary

This trial is studying a treatment called Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) for couples where one partner has posttraumatic stress disorder (PTSD). The treatment aims to

Who is the study for?

This trial is for veterans with PTSD who are in a relationship. It's designed to help improve both their PTSD symptoms and relationship quality. Participants must be willing to undergo couples therapy and use either an oxytocin or saline nasal spray.Check my eligibility

What is being tested?

The study tests if adding oxytocin nasal spray to brief couples therapy (bCBCT) is more effective than just the therapy with a saline placebo. The goal is to see if this combination can better treat PTSD and enhance relationship satisfaction among veterans.See study design

What are the potential side effects?

Oxytocin nasal spray may cause side effects like irritation inside the nose, headache, changes in heart rate or blood pressure, emotional changes, and possibly altered social behavior.

CBCT-OT RCT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I agree not to undergo any other PTSD-focused therapy during the study.

CBCT-OT RCT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline - 6-months post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline - 6-months post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline - 6-months post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PTSD diagnosis and severity change

Secondary outcome measures

Relationship satisfaction

Other outcome measures

Communication

Empathy

Psychosocial functioning

+1 more

CBCT-OT RCT Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal OxytocinExperimental Treatment2 Interventions

Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) weekly. Prior to each session, the veteran participant will self-administer intranasal oxytocin.

Group II: Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal PlaceboPlacebo Group2 Interventions

Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) weekly. Prior to each session, the veteran participant will self-administer intranasal placebo solution.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oxytocin nasal spray

2016

Completed Phase 4

~1480

Brief Cognitive-Behavioral Conjoint Therapy

2022

Completed Phase 2

~20

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,612 Previous Clinical Trials

3,305,503 Total Patients Enrolled

Leslie A. Morland, PsyDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA

1 Previous Clinical Trials

274 Total Patients Enrolled

Lauren M. Sippel, PhDPrincipal InvestigatorVA Connecticut Healthcare System West Haven Campus, West Haven, CT

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for potential participants in this research study?

"As per the current information available on clinicaltrials.gov, this specific study is not actively seeking patients. The trial was initially posted on April 1st, 2024 and last updated on December 22nd, 2023. However, it's worth noting that there are currently 395 other ongoing studies that are actively accepting patients for participation."

Answered by AI

Has the combination of Brief Cognitive Behavioral Conjoint Therapy for PTSD and Intranasal Oxytocin been granted approval by the FDA?

"Based on the classification of this trial as Phase 2, our team at Power rates the safety of Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Oxytocin a 2. This suggests that there is some preliminary evidence supporting its safety but no data yet regarding efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Randomized Clinical Trial Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD

2024. "A Randomized Clinical Trial Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06194851.

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