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Trial record 18 of 18 for:    citadel

Intensive Weekend Retreat Multi-Couple Group Therapy for PTSD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03158558
Recruitment Status : Completed
First Posted : May 18, 2017
Last Update Posted : December 18, 2018
Sponsor:
Collaborators:
United States Department of Defense
US Department of Veterans Affairs
The University of Texas Health Science Center at San Antonio
The Citadel
Ryerson University
University of Denver
Duke University
VA Boston Healthcare System
Information provided by (Responsible Party):
Steffany J Fredman, Ph.D., Penn State University

Brief Summary:
The purpose of this study is to test an intensive, multi-couple group version of a couple therapy for PTSD delivered to active duty Service Members or Veterans with PTSD and their romantic partners in a single weekend retreat. The study will be conducted on or near Fort Hood in Kileen, Texas. Twenty-four couples will be treated with this therapy and assessed immediately before treatment, 1 month after treatment, and 3 months after treatment.

Condition or disease Intervention/treatment Phase
PTSD Behavioral: Accelerated, Multi-Couple Group CBCT for PTSD Not Applicable

Detailed Description:

Numerous studies have documented an association between posttraumatic stress disorder (PTSD) symptoms and intimate relationship problems in both Service Members and Veterans and their partners, including relationship distress, physical and psychological aggression, and psychological distress in partners. In prior work, the investigators have demonstrated that cognitive-behavioral conjoint therapy for PTSD (CBCT for PTSD), a 15-session couple-based therapy for PTSD, is efficacious in simultaneously treating PTSD and comorbid symptoms and improving intimate relationship functioning. However, the current format of fifteen 75-minute sessions over 15 weeks presents challenges for large-scale dissemination for active duty Service Members and recently discharged Veterans who have deployed in support of 9/11.

The purpose of this uncontrolled trial is to pilot a brief, scalable version of CBCT for PTSD in which session content is taught in an accelerated, multi-couple group format (AM-CBCT for PTSD) that has the potential for rapid dissemination and implementation, while capturing the majority of the benefits of the original therapy format. Accelerated, multi-couple group CBCT for PTSD (AM-CBCT for PTSD) will be delivered in a single weekend retreat to 24 active duty Service Members and recently discharged Veterans with PTSD who have deployed post-9/11 and their partners. Participants will be assessed at pre-treatment, one month after treatment, and 3 months after treatment.

The study seeks to answer the following questions:

  1. Will accelerated, multi-couple group CBCT for PTSD delivered in a weekend retreat (AM-CBCT for PTSD) be associated with significant improvements in clinician-rated PTSD symptom severity, as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), one month after treatment and at 3-month follow-up?
  2. Will accelerated, multi-couple group CBCT for PTSD delivered in a weekend retreat (AM-CBCT for PTSD) be associated with significant improvements in secondary outcomes (e.g., patient self-reported PTSD and comorbid symptom severity, relationship satisfaction), one month after treatment and at 3-month follow-up?

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-Couple Group Intervention for PTSD
Actual Study Start Date : September 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018

Arm Intervention/treatment
Experimental: AM-CBCT for PTSD
Accelerated, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy delivered in a single weekend retreat
Behavioral: Accelerated, Multi-Couple Group CBCT for PTSD
Intensive weekend retreat version of cognitive-behavioral conjoint therapy for PTSD (Monson & Fredman, 2012)
Other Name: AM-CBCT for PTSD




Primary Outcome Measures :
  1. Clinician Administered PTSD Scale (CAPS-5) [ Time Frame: change in PTSD symptoms at 1 and 3 months posttreatment ]
    semi-structured clinician interview to determine presence and severity of PTSD symptoms


Secondary Outcome Measures :
  1. PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: change in PTSD symptoms at 1 and 3 months posttreatment ]
    patient self-report rating of PTSD symptom severity

  2. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: change in PTSD symptoms at 1 and 3 months posttreatment ]
    self-report measure of depressive symptom severity

  3. Couples Satisfaction Index (CSI) [ Time Frame: change in relationship satisfaction at 1 and 3 months posttreatment ]
    self-report measure of relationship satisfaction



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Married or cohabitating couples who have been together the past 3 months in which one partner is a Service Member or recently discharged Veterans eligible for treatment at Carl R. Darnall Army Medical Center (CRDAMC) with PTSD who has deployed since 9/11, seeking treatment for PTSD.
  • Diagnosis of PTSD as determined by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and a CAPS-5 score > 25. The Service Member or Veteran with PTSD must have experienced a Criterion A event that is a specific combat-related event or high magnitude operational experience that occurred during a military deployment in support of combat operations following 9/11. The diagnosis of PTSD may be indexed to that event or to another Criterion A event.
  • Both individuals must be able to speak and read English.

Exclusion Criteria:

  • Couple is separated and/or has taken steps to dissolve their relationship (e.g., divorce)
  • Currently participating in evidence-based treatment for PTSD (Prolonged Exposure, Cognitive Processing Therapy, or Cognitive-Behavioral Conjoint Therapy for PTSD).
  • Recent manic episode (past 12 months) or a psychotic disorder (as determined by the Mania and Psychosis modules of the MINI)
  • Current alcohol dependence (as determined by an a score of ≥ 4 on items #4-6 and a total score of ≥20 on the AUDIT)
  • Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires)
  • Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index - Suicidality Subscale; DSI-SS)
  • Evidence or admission of severe intimate aggression as indicated by a "yes" endorsement to the one-question Screen for Conflict Question by either member of the couple occurring within the past 6-months.
  • Partner who meets diagnostic criteria for PTSD according to the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) or PTSD Checklist - Stressor Specific (PCL-S).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03158558


Locations
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United States, Texas
University of Texas Health Sciences Center San Antonio
Killeen, Texas, United States, 76544
Sponsors and Collaborators
Penn State University
United States Department of Defense
US Department of Veterans Affairs
The University of Texas Health Science Center at San Antonio
The Citadel
Ryerson University
University of Denver
Duke University
VA Boston Healthcare System
Investigators
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Principal Investigator: Steffany J. Fredman, Ph.D. The Pennsylvania State University

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Responsible Party: Steffany J Fredman, Ph.D., Assistant Professor of Human Development and Family Studies, Penn State University
ClinicalTrials.gov Identifier: NCT03158558     History of Changes
Other Study ID Numbers: HSC20160094H
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No