RCT of Intensive Multi-Couple Therapy for PTSD Versus Relationship Education in Military Couples

Sponsor
Penn State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06047691
Collaborator
The University of Texas Health Science Center at San Antonio (Other), University of Denver (Other), Toronto Metropolitan University (Other)
120
1
2
29
4.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD
  • Behavioral: Prevention and Relationship Education Program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trial with parallel group designRandomized controlled trial with parallel group design
Masking:
Single (Outcomes Assessor)
Masking Description:
Independent evaluators will be blinded as to participant treatment condition during follow-up assessments.
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial of Intensive Multi-Couple Therapy for PTSD Versus Relationship Education in Military Couples
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2026
Anticipated Study Completion Date :
Feb 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD

AIM-CBCT for PTSD is an abbreviated, intensive, multi-couple group version of cognitive-behavioral conjoint therapy for PTSD, an evidence-based treatment for PTSD delivered in a conjoint format.

Behavioral: Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD
Approximately 12 hours of programming delivered over 2 consecutive days in a multi-couple group retreat format. Couples are provided with psychoeducation about PTSD and relationship functioning and are taught cognitive and behavioral skills to address the manifestation of PTSD in the couple relationship. Couples will also meet once individually with one of the group leaders 1-2 weeks before the retreat and once 1-2 weeks after the retreat.

Active Comparator: Prevention and Relationship Education Program

PREP is an evidence-based relationship education program delivered in a multi-couple group format.

Behavioral: Prevention and Relationship Education Program
Approximately 12 hours of programming delivered over 2 consecutive days in a multi-couple group retreat format.The content of PREP and workshop experiences focuses on helping couples communicate effectively, manage conflict without harming their relationship, preserve and act on commitment, improve relationship decision-making, increase understanding of differences between partners, and protect positive connections between partners. Approximately 12 hours of PREP content will be delivered over 2 consecutive days in a multi-couple group retreat format. Couples will also meet once individually with one of the group leaders 1-2 weeks before the retreat and will check in with a member of the study staff 1-2 weeks after the retreat.

Outcome Measures

Primary Outcome Measures

  1. Clinician-Administered PTSD Scale for DSM-5 [baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up]

    clinician-rated PTSD symptoms

Secondary Outcome Measures

  1. PTSD Checklist for DSM-5 [baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up]

    self-reported PTSD symptoms

  2. Patient Health Questionnaire-9 [baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up]

    self-reported depressive symptoms

  3. Couples Satisfaction Index-32 [baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up]

    relationship satisfaction

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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-5 and a CAPS-5 score of 25 or higher.

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229

Sponsors and Collaborators

  • Penn State University
  • The University of Texas Health Science Center at San Antonio
  • University of Denver
  • Toronto Metropolitan University

Investigators

  • Principal Investigator: Steffany J Fredman, Ph.D., Penn State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Steffany J Fredman, Ph.D., Associate Professor of Human Development and Family Studies and Psychology, Penn State University
ClinicalTrials.gov Identifier:
NCT06047691
Other Study ID Numbers:
  • SITE00001245
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Steffany J Fredman, Ph.D., Associate Professor of Human Development and Family Studies and Psychology, Penn State University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2023