NCT05207436

Brief Summary

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

January 17, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
6 months until next milestone

Results Posted

Study results publicly available

July 10, 2023

Completed
Last Updated

July 10, 2023

Status Verified

June 1, 2023

Enrollment Period

9 months

First QC Date

January 6, 2022

Results QC Date

March 29, 2023

Last Update Submit

June 16, 2023

Conditions

Post Traumatic Stress DisorderRelational Problems

Keywords

Post Traumatic Stress DisorderOxytocinMarital TherapyCouplesVeteransTelemedicine

Outcome Measures

Primary Outcomes (3)

  • Couples Satisfaction Inventory-32

    The Couples Satisfaction Index is a 32-item self-report survey assessing several domains of relationship satisfaction. Higher sum scores (range 0 to 161) represent higher relationship satisfaction.

    baseline

  • Couples Satisfaction Inventory-32

    The Couples Satisfaction Index is a 32-item self-report survey assessing several domains of relationship satisfaction. Higher sum scores (range 0 to 161) represent higher relationship satisfaction.

    immediately after the intervention (approximately 2-months after baseline)

  • Couples Satisfaction Inventory-32

    The Couples Satisfaction Index is a 32-item self-report survey assessing several domains of relationship satisfaction. Higher sum scores (range 0 to 161) represent higher relationship satisfaction.

    three months post-treatment (approximately 5-months after baseline)

Secondary Outcomes (6)

  • PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (PCL-5)

    baseline

  • PTSD Checklist for DSM-5 (PCL-5)

    immediately after the intervention (approximately 2-months after baseline)

  • PTSD Checklist for DSM-5 (PCL-5)

    three months post-treatment (approximately 5-months after baseline)

  • Brief Inventory of Psychosocial Functioning

    baseline

  • Brief Inventory of Psychosocial Functioning

    immediately after the intervention (approximately 2-months after baseline)

  • +1 more secondary outcomes

Other Outcomes (12)

  • World Health Organization Quality of Life - Brief (BREF) - Physical

    baseline

  • World Health Organization Quality of Life - BREF - Physical

    immediately after the intervention (approximately 2-months after baseline)

  • World Health Organization Quality of Life - BREF - Physical

    three months post-treatment (approximately 5-months after baseline)

  • +9 more other outcomes

Study Arms (1)

Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Oxytocin

EXPERIMENTAL

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).

Drug: Oxytocin nasal sprayBehavioral: Brief Cognitive-Behavioral Conjoint Therapy

Interventions

Oxytocin nasal sprayDRUG

Veteran participants will self-administer 40 IU of intranasal oxytocin 30 minutes before the start of each B-CBCT session.

Also known as: Pitocin
Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Oxytocin
Brief Cognitive-Behavioral Conjoint TherapyBEHAVIORAL

Eight sessions of standardized B-CBCT, a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning.

Also known as: B-CBCT
Brief Cognitive Behavioral Conjoint Therapy for PTSD plus Intranasal Oxytocin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Leslie Morland
Organization
VA San Diego Healthcare System
leslie.morland@va.gov
858-226-5765

Study Officials

  • Leslie Morland, PsyD

    VA San Diego Healthcare System, San Diego, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Telemental Health, Staff Clinical Psychologist

Study Record Dates

First Submitted

January 6, 2022

First Posted

January 26, 2022

Study Start

January 17, 2022

Primary Completion

September 30, 2022

Study Completion

December 31, 2022

Last Updated

July 10, 2023

Results First Posted

July 10, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)