NCT03158558

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

December 19, 2018

Status Verified

December 1, 2018

Enrollment Period

1.4 years

First QC Date

May 15, 2017

Last Update Submit

December 17, 2018

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

  • Clinician Administered PTSD Scale (CAPS-5)

    semi-structured clinician interview to determine presence and severity of PTSD symptoms

    change in PTSD symptoms at 1 and 3 months posttreatment

Secondary Outcomes (3)

  • PTSD Checklist for DSM-5 (PCL-5)

    change in PTSD symptoms at 1 and 3 months posttreatment

  • Patient Health Questionnaire-9 (PHQ-9)

    change in PTSD symptoms at 1 and 3 months posttreatment

  • Couples Satisfaction Index (CSI)

    change in relationship satisfaction at 1 and 3 months posttreatment

Study Arms (1)

AM-CBCT for PTSD

EXPERIMENTAL

Accelerated, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy delivered in a single weekend retreat

Behavioral: Accelerated, Multi-Couple Group CBCT for PTSD

Interventions

Accelerated, Multi-Couple Group CBCT for PTSDBEHAVIORAL

Intensive weekend retreat version of cognitive-behavioral conjoint therapy for PTSD (Monson \& Fredman, 2012)

Also known as: AM-CBCT for PTSD
AM-CBCT for PTSD

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Sciences Center San Antonio

Killeen, Texas, 76544, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Steffany J. Fredman, Ph.D.

    The Pennsylvania State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Human Development and Family Studies

Study Record Dates

First Submitted

May 15, 2017

First Posted

May 18, 2017

Study Start

September 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

December 19, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)