Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06047691
Other study ID # SITE00001245
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Completed NCT03384706 - A Comparison of CPT Versus ART Versus WL N/A
Completed NCT03418129 - Neuromodulatory Treatments for Pain Management in TBI N/A
Completed NCT03129204 - Sensation Awareness Focused Training for Spouses N/A
Recruiting NCT05651295 - A Precision Medicine Approach to Target Engagement for Emotion Regulation N/A
Completed NCT05113277 - Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention N/A
Recruiting NCT05327504 - Written Exposure Therapy for Veterans With SUD and PTSD N/A
Recruiting NCT05843695 - Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety N/A
Active, not recruiting NCT05530642 - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel N/A
Completed NCT00644423 - Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD) N/A
Completed NCT02989987 - NET for SGBV Survivors in Eastern DR Congo N/A
Completed NCT02320799 - Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV+ Women in Kenya N/A
Recruiting NCT02293291 - Thermal Clinic Treatment in Gulf War Illness Phase 1/Phase 2
Completed NCT02242136 - Treatment of Posttraumatic Stress Disorder and Aggressive Behavior in Soldiers and Ex-combatants N/A
Completed NCT02720497 - The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD N/A
Completed NCT01911585 - Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure N/A
Completed NCT01693978 - Contingency Outcomes in Prolonged Exposure N/A
Terminated NCT01408641 - Topiramate for Alcohol Use in Posttraumatic Stress Disorder N/A
Completed NCT01469754 - Longitudinal Survey Analysis in Lymphoma Survivors N/A
Completed NCT02362477 - Telemental Health and Cognitive Processing Therapy for Female Veterans With Military-related PTSD Phase 3
Terminated NCT01239173 - Emotional Memory Reactivation in Posttraumatic Stress Disorder Phase 3