Intranasal Oxytocin for Veterans with PTSD in Couples Therapy
This study is for Veterans aged 18 or older who have Post-Traumatic Stress Disorder (PTSD) and are in a relationship. It explores if adding oxytocin nasal spray to Brief Cognitive-Behavioral Conjoint Therapy (bCBCT) can better help with PTSD symptoms and relationship satisfaction. bCBCT is a type of therapy where couples work together to improve PTSD and relationship issues. You would either receive oxytocin nasal spray or a saline (saltwater) nasal spray, both given before each therapy session. The study aims to see if this combination improves PTSD diagnosis and severity up to six months after treatment. The study is currently recruiting up to 240 participants.
- Study design
- This study is interventional and plans to enroll 240 participants. It compares oxytocin nasal spray with a placebo (saline nasal spray) alongside Brief Cognitive-Behavioral Conjoint Therapy.
- What's involved
- Veteran participants will self-administer a nasal spray 30 minutes before each of eight bCBCT sessions. The therapy sessions are 75 minutes long.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for changes in PTSD diagnosis and severity up to six months post-treatment.
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Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Leslie A. Morland, PsyD · PRINCIPAL_INVESTIGATOR · VA San Diego Healthcare System, San Diego, CA
- Lauren M. Sippel, PhD · PRINCIPAL_INVESTIGATOR · VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Who to contact
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What this trial measures
- PTSD diagnosis and severity changeBaseline - 6-months post treatment
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 range from 0 to 80 with higher scores indicating greater severity. CAPS-5 will be completed by veterans with PTSD only.