- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06047691
Intensive Multi-Couple Therapy for PTSD Versus Relationship Education in Military Couples
Randomized Controlled Trial of Intensive Multi-Couple Therapy for PTSD Versus Relationship Education in Military Couples
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Steffany J Fredman, Ph.D.
- Phone Number: 781-879-9758
- Email: sjf23@psu.edu
Study Contact Backup
- Name: Alan L Peterson, Ph.D.
- Phone Number: (210) 562-6700
- Email: petersona3@uthscsa.edu
Study Locations
-
-
Texas
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San Antonio, Texas, United States, 78229
- Recruiting
- University of Texas Health Science Center at San Antonio
-
Contact:
- Alan Peterson, Ph.D.
- Phone Number: 210-562-6703
- Email: petersona3@uthscsa.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 warranting immediate intervention
- Symptoms of moderate to severe other substance use warranting immediate intervention
- Recent (past month) manic episode or psychotic disorder symptoms in either partner
- Other psychiatric disorders severe enough to warrant designation as the primary disorder
- 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 by either partner occurring within the past 6-months.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
|
|
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.
|
baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
|
|
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.
|
baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
|
|
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.
|
baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
|
|
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.
|
baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Steffany J Fredman, Ph.D., Penn State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SITE00001245
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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