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

Posttraumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06047691
• Other study ID #: SITE00001245
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: February 2026

Study information

• Verified date: February 2024
• Source: Penn State University
• Contact: Steffany J Fredman, Ph.D.
• Phone: 781-879-9758
• Email: sjf23[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Penn State University	The University of Texas Health Science Center at San Antonio, Toronto Metropolitan University, University of Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PTSD Checklist for DSM-5	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.	baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Secondary	Patient Health Questionnaire-9	Self-reported depressive symptoms. Scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.	baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Secondary	Generalized Anxiety Disorder-Screener	Self-reported general anxiety symptoms. Scores range from 0 to 21, with higher scores indicating greater anxiety.	baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Secondary	Dimensions of Anger Reactions-5	Self-reported anger symptoms. Scores range from 5 to 25, with higher scores indicating greater anger.	baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Secondary	Couples Satisfaction Index-32	Self-reported relationship satisfaction. Scores range from 0 to 161, with higher scores indicating higher relationship satisfaction.	baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up