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Clinical Trials/NCT06047691
NCT06047691
Recruiting
N/A

Randomized Controlled Trial of Intensive Multi-Couple Therapy for PTSD Versus Relationship Education in Military Couples

Penn State University1 site in 1 country120 target enrollmentSeptember 15, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Posttraumatic Stress Disorder
Sponsor
Penn State University
Enrollment
120
Locations
1
Primary Endpoint
Clinician-Administered PTSD Scale for DSM-5
Status
Recruiting
Last Updated
11 months ago

Overview

Brief Summary

The goal of this clinical trial is to test an abbreviated, intensive, multi-couple group version of cognitive-behavioral conjoint therapy for PTSD (AIM-CBCT for PTSD) in an active military and veteran population. The main questions it aims to answer are:

  • Does AIM-CBCT for PTSD improve PTSD symptoms?
  • Does AIM-CBCT for PTSD improve associated symptoms (e.g., depression), romantic partner distress, and couple relationship satisfaction?

Participants will participate in a two-day retreat in which they are taught and practice skills to decrease PTSD symptoms and enhance their relationships. Researchers will compare AIM-CBCT for PTSD to the Prevention and Relationship Education Program (PREP) to determine whether it is superior to an evidence-based relationship education curriculum that is also delivered in a two-day multi-couple group format.

Registry
clinicaltrials.gov
Start Date
September 15, 2023
End Date
February 2026
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Steffany J Fredman, Ph.D.

Associate Professor of Human Development and Family Studies and Psychology

Penn State University

Eligibility Criteria

Inclusion Criteria

  • Service member or veteran and a romantic partner willing to participate.
  • Couple is married or cohabiting for at least 3 months. Couple can be either different or same sex.
  • Service member/veteran diagnosis of PTSD as determined by the CAPS-
  • Each partner is at least 18 years old.
  • Both partners able to speak and read English.

Exclusion Criteria

  • Either partner reports current suicidal ideation severe enough to warrant immediate attention
  • Current homicide risk meriting crisis intervention for either partner
  • Current and severe alcohol misuse in either partner in the past 12 weeks and/or warranting immediate intervention
  • Recent (past month) manic episode or psychotic disorder symptoms in either partner
  • Evidence of a moderate or severe traumatic brain injury or other cognitive impairment in either partner
  • Couple is separated or have taken steps to dissolve their relationship
  • Either partner is currently participating in evidence-based treatment for PTSD (e.g., Prolonged Exposure, Cognitive Processing Therapy, Present-Centered Therapy for PTSD, Eye Movement Desensitization and Reprocessing, Cognitive-Behavioral Conjoint Therapy for PTSD, or Structured Approach Therapy).
  • Evidence or admission of severe intimate aggression as indicated by a "yes" endorsement to the one-question Screen for Conflict Question by either partner occurring within the past 6-months.

Outcomes

Primary Outcomes

Clinician-Administered PTSD Scale for DSM-5

Time Frame: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up

Interviewer ratings of posttraumatic stress disorder (PTSD) symptoms identified in the Diagnostic and Statistical Manual for Mental Disorders, Fifth Edition. Scores range from 0-80, with higher scores indicating more severe PTSD symptoms.

Secondary Outcomes

  • PTSD Checklist for DSM-5(baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up)
  • Dimensions of Anger Reactions-5(baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up)
  • Couples Satisfaction Index-32(baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up)
  • Patient Health Questionnaire-9(baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up)
  • Generalized Anxiety Disorder-Screener(baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up)

Study Sites (1)

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