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

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ClinicalTrials.gov Identifier: NCT06047691
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : February 20, 2024
Sponsor:
Collaborators:
The University of Texas Health Science Center at San Antonio
University of Denver
Toronto Metropolitan University
Information provided by (Responsible Party):
Steffany J Fredman, Ph.D., Penn State University

Study Description
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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
Posttraumatic Stress Disorder Behavioral: Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD Behavioral: Prevention and Relationship Education Program Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 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
Actual Study Start Date : September 15, 2023
Estimated Primary Completion Date : February 2026
Estimated Study Completion Date : February 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. PTSD Checklist for DSM-5 [ Time Frame: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up ]
    Participant's self-report 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.

  2. Patient Health Questionnaire-9 [ Time Frame: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up ]
    Self-reported depressive symptoms. Scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.

  3. Generalized Anxiety Disorder-Screener [ Time Frame: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up ]
    Self-reported general anxiety symptoms. Scores range from 0 to 21, with higher scores indicating greater anxiety.

  4. Dimensions of Anger Reactions-5 [ Time Frame: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up ]
    Self-reported anger symptoms. Scores range from 5 to 25, with higher scores indicating greater anger.

  5. Couples Satisfaction Index-32 [ Time Frame: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up ]
    Self-reported relationship satisfaction. Scores range from 0 to 161, with higher scores indicating higher relationship satisfaction.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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-5.
  • 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06047691


Contacts
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Contact: Steffany J Fredman, Ph.D. 781-879-9758 sjf23@psu.edu
Contact: Alan L Peterson, Ph.D. (210) 562-6700 petersona3@uthscsa.edu

Locations
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United States, Texas
University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Alan Peterson, Ph.D.    210-562-6703    petersona3@uthscsa.edu   
Sponsors and Collaborators
Penn State University
The University of Texas Health Science Center at San Antonio
University of Denver
Toronto Metropolitan University
Investigators
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Principal Investigator: Steffany J Fredman, Ph.D. Penn State University
More Information
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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: September 21, 2023    Key Record Dates
Last Update Posted: February 20, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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., Penn State University:
PTSD
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders