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

NCT06047691 | Recruiting DMC

• 1 other identifier: SITE00001245
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD

Outcome Measures

Primary Outcomes (1)

• Clinician-Administered PTSD Scale for DSM-5

  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.

  baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up

Secondary Outcomes (5)

• PTSD Checklist for DSM-5

  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

• 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

Study Arms (2)

Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD

EXPERIMENTAL

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

Prevention and Relationship Education Program

ACTIVE COMPARATOR

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

Behavioral: Prevention and Relationship Education Program

Interventions

Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD BEHAVIORAL

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.

Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD

Prevention and Relationship Education Program BEHAVIORAL

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.

Prevention and Relationship Education Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Each partner is at least 18 years old.
• Both partners able to speak and read English.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Steffany J Fredman, Ph.D.

  Penn State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steffany J Fredman, Ph.D.

CONTACT

781-879-9758; sjf23@psu.edu

Alan L Peterson, Ph.D.

CONTACT

(210) 562-6700; petersona3@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent evaluators will be blinded as to participant treatment condition during follow-up assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Human Development and Family Studies and Psychology

Model Details: Randomized controlled trial with parallel group design

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: September 15, 2023
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)