Intensive Weekend Retreat Multi-Couple Group Therapy for PTSD

December 17, 2018 updated by: Steffany J Fredman, Ph.D., Penn State University

Multi-Couple Group Intervention for PTSD

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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?

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Killeen, Texas, United States, 76544
        • University of Texas Health Sciences Center San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • AM-CBCT for PTSD

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
change in PTSD symptoms at 1 and 3 months posttreatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
change in PTSD symptoms at 1 and 3 months posttreatment
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
change in PTSD symptoms at 1 and 3 months posttreatment
Couples Satisfaction Index (CSI)
Time Frame: change in relationship satisfaction at 1 and 3 months posttreatment
self-report measure of relationship satisfaction
change in relationship satisfaction at 1 and 3 months posttreatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penn State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
United States Department of Defense
Duke University
US Department of Veterans Affairs
Ryerson University
The University of Texas Health Science Center at San Antonio
VA Boston Healthcare System
University of Denver
The Citadel

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Steffany J. Fredman, Ph.D., The Pennsylvania State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC20160094H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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