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Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Oxytocin for Post-Traumatic Stress Disorder (CBCT+OT Trial)
Phase 2
Waitlist Available
Led By Leslie Morland, PsyD
Research Sponsored by San Diego Veterans Healthcare System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three months post-treatment (approximately 5-months after baseline)
Awards & highlights
CBCT+OT Trial Summary
This trial is testing whether adding a hormone spray to an existing PTSD treatment can help improve the treatment's effectiveness in reducing PTSD symptoms and improving relationship satisfaction for Veterans and their romantic partners.
Eligible Conditions
- Post-Traumatic Stress Disorder
- Relationship Issues
CBCT+OT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ three months post-treatment (approximately 5-months after baseline)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three months post-treatment (approximately 5-months after baseline)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Couples Satisfaction Inventory-32
Secondary outcome measures
Brief Inventory of Psychosocial Functioning
PTSD Checklist for DSM-5 (PCL-5)
PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5)
Other outcome measures
World Health Organization Quality of Life - BREF - Environment
World Health Organization Quality of Life - BREF - Physical
World Health Organization Quality of Life - BREF - Psychological
+2 moreCBCT+OT Trial Design
1Treatment groups
Experimental Treatment
Group I: Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal OxytocinExperimental Treatment2 Interventions
Couples will receive Brief Cognitive-Behavioral Conjoint Therapy (B-CBCT) weekly. Prior to each session, the Veteran participant will self-administer intranasal oxytocin. The estimated length of treatment participation is 8 to 15 weeks. All procedures take place in the Veterans home via home-based clinical video teleconferencing (CVT).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin
FDA approved
Brief Cognitive-Behavioral Conjoint Therapy
2022
Completed Phase 2
~20
Find a Location
Who is running the clinical trial?
San Diego Veterans Healthcare SystemLead Sponsor
34 Previous Clinical Trials
3,886 Total Patients Enrolled
Leslie Morland, PsyDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
1 Previous Clinical Trials
175 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Brief Cognitive Behavioral Conjoint Therapy for PTSD supplemented with Intranasal Oxytocin?
"Though there is limited evidence of its efficacy, the safety profile for Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Oxytocin was assessed at a level 2 due to available clinical data regarding it's safety."
Answered by AI
Are there still opportunities to join this research endeavor?
"Unfortunately, this medical research is no longer accepting participants as of January 19th 2022. Nevertheless, 420 other studies remain open and are actively searching for potential candidates."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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