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

Primary Purpose

Posttraumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD
Prevention and Relationship Education Program
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Texas Health Science Center at San AntonioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Prevention and Relationship Education Program

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Clinician-Administered PTSD Scale for DSM-5
clinician-rated PTSD symptoms

Secondary Outcome Measures

PTSD Checklist for DSM-5
self-reported PTSD symptoms
Patient Health Questionnaire-9
self-reported depressive symptoms
Couples Satisfaction Index-32
relationship satisfaction

Full Information

First Posted
September 14, 2023
Last Updated
September 14, 2023
Sponsor
Penn State University
Collaborators
The University of Texas Health Science Center at San Antonio, University of Denver, Toronto Metropolitan University
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1. Study Identification

Unique Protocol Identification Number
NCT06047691
Brief Title
RCT of Intensive Multi-Couple Therapy for PTSD Versus Relationship Education in Military Couples
Official Title
Randomized Controlled Trial of Intensive Multi-Couple Therapy for PTSD Versus Relationship Education in Military Couples
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
Collaborators
The University of Texas Health Science Center at San Antonio, University of Denver, Toronto Metropolitan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial with parallel group design
Masking
Outcomes Assessor
Masking Description
Independent evaluators will be blinded as to participant treatment condition during follow-up assessments.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD
Arm Type
Experimental
Arm Description
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.
Arm Title
Prevention and Relationship Education Program
Arm Type
Active Comparator
Arm Description
PREP is an evidence-based relationship education program delivered in a multi-couple group format.
Intervention Type
Behavioral
Intervention Name(s)
Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Prevention and Relationship Education Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinician-Administered PTSD Scale for DSM-5
Description
clinician-rated PTSD symptoms
Time Frame
baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Secondary Outcome Measure Information:
Title
PTSD Checklist for DSM-5
Description
self-reported PTSD symptoms
Time Frame
baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Title
Patient Health Questionnaire-9
Description
self-reported depressive symptoms
Time Frame
baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Title
Couples Satisfaction Index-32
Description
relationship satisfaction
Time Frame
baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steffany J Fredman, Ph.D.
Phone
781-879-9758
Email
sjf23@psu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alan L Peterson, Ph.D.
Phone
(210) 562-6700
Email
petersona3@uthscsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steffany J Fredman, Ph.D.
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Peterson, Ph.D.
Phone
210-562-6703
Email
petersona3@uthscsa.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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