Clinical trial NCT06047691: 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
Overall status: RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center at San Antonio
name: University of Denver
name: Toronto Metropolitan University
First posted: 2023-09-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with parallel group design
Primary purpose: TREATMENT

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.


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.
* 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.

Primary outcomes:
measure: Clinician-Administered PTSD Scale for DSM-5
timeFrame: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Secondary outcomes:
measure: PTSD Checklist for DSM-5
timeFrame: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
measure: Patient Health Questionnaire-9
timeFrame: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
measure: Generalized Anxiety Disorder-Screener
timeFrame: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
measure: Dimensions of Anger Reactions-5
timeFrame: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
measure: Couples Satisfaction Index-32
timeFrame: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: Penn State University
name: Steffany J Fredman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: