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Clinical trial

Pilot Test of Intranasal Oxytocin as an Enhancer of Brief Couples Therapy for PTSD

ID
Name
1227284
Description
In 2019 VA mandated that all Veterans seeking mental health care have access to flexible family mental health services in VA (VHA directive 1163.04). This study aims to respond to this mandate by further improving an evidence-based PTSD treatment designed to decrease PTSD symptoms and improve relationship satisfaction for Veterans and their romantic partners. Brief Cognitive-Behavioral Conjoint Therapy (B-CBCT), an 8-session dyadic psychotherapy for PTSD, has been found to significantly reduce PTSD symptoms, but the effects of B-CBCT on relationship satisfaction are less reliable and robust. Pharmacological augmentation of psychotherapy utilizing intranasal oxytocin, a neurohormone that influences mechanisms of trauma recovery and social behavior, may help improve relationship satisfaction outcomes. If successful, the proposed study will advance knowledge of strategies for improving Veterans' quality of life by improving their intimate relationships along with PTSD symptoms.
Trial arms
Trial start
2022-01-17
Estimated PCD
2022-09-30
Trial end
2022-12-31
Status
Completed
Phase
Early phase I
Treatment
Oxytocin nasal spray
Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each B-CBCT session.
Arms:
Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Oxytocin
Other names:
Pitocin
Brief Cognitive-Behavioral Conjoint Therapy
Eight sessions of standardized B-CBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.
Arms:
Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Oxytocin
Other names:
B-CBCT
Size
20
Primary endpoint
Couples Satisfaction Inventory-32
baseline
Couples Satisfaction Inventory-32
immediately after the intervention (approximately 2-months after baseline)
Couples Satisfaction Inventory-32
three months post-treatment (approximately 5-months after baseline)
Eligibility criteria
Inclusion Criteria: * One member of the couple be a Veteran enrolled in the San Diego VA Healthcare System with a Posttraumatic Stress Disorder Checklist-5 score of \> 33, indicating a likely PTSD diagnosis. * Agree not to receive other individual or conjoint psychotherapy for PTSD during the treatment portion of the study * If already on psychoactive medication prior to study referral, Veteran participant must remain on a stable psychoactive medication regimen for at least 45 days. Exclusion Criteria: * Acute suicidality * Psychosis * Active substance use disorder * Severe ongoing medical problems, including heart disease and neuroendocrinological disorders (e.g., diabetes) * Uncontrolled hypotension (systolic blood pressure \<100 mm Hg) or hypertension (\>160/100 mm Hg) * Pregnancy, delivery in the past 6 months, or current breastfeeding * Severe intimate aggression reported by either partner
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ACTUAL'}}
Updated at
2023-07-10

1 organization

1 product

2 indications

Organization
San Diego Veterans Healthcare System
Product
Oxytocin
Indication
Post-Traumatic Stress Disorder
Indication
Relationship Problems