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Comparison of Couple-Based PTSD Treatment and Couple-Based PTSD Education

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VA Office of Research and Development

Status

Completed

Conditions

Stress Disorders, Post-Traumatic

Treatments

Behavioral: Structured Approach Therapy
Other: PTSD Family Education

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01022203
B6756-R

Details and patient eligibility

About

The study is designed to evaluate the efficacy of a novel couple-based treatment for PTSD, called Structured Approach Therapy, to decrease PTSD and improve the marital and social functioning of Iraqi war Veterans and their partners. The effectiveness of couples therapy will be compared with the effectiveness of a couple-based educational intervention.

Full description

The goal of the proposed study is to test the efficacy of a novel couple-based PTSD treatment, called Structured Approach Therapy, by randomly assigning 57 Iraqi war Veterans and their partners to either a 12-15 session Structured Approach Therapy program, or to a 12-15 session PTSD Family Education comparison condition. The efficacy of the two experimental conditions will be ascertained by obtaining measures of PTSD severity from Veterans and measures of relationship functioning and emotion regulation from Veterans and their partners prior to treatment, immediately after treatment, and three months after the last treatment session. The investigators will test the hypothesis that couples participating in Structured Approach Therapy will show significantly greater improvements on all three clinical outcome measures than couples participating in PTSD Family Education. These hypotheses will be tested with an intent-to-treat analysis using general linear mixed models with main effects of treatment, time (baseline, end of treatment, and 12 week follow-up), and treatment by time interactions to model the longitudinal trajectories of the outcome, separately for the Veterans and their partners. The objectives of the Structured Approach Therapy intervention are to decrease PTSD severity, improve relationship and family functioning, and decrease problems in emotion regulation in a group of young Veterans at risk for developing chronic PTSD, and to reduce emotional distress and relationship and family problems in their partners.

Enrollment

138 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Exposure to at least one combat-related stressful event during combat deployment,
  • Current diagnostic criteria for PTSD for that event, and
  • Veteran is in a committed relationship and living with an opposite sex partner for at least six months.

Exclusion criteria

  • Current psychotic symptoms in either partner,
  • Current diagnosis of alcohol or drug dependence in either partner,
  • History of recent physical assault/abuse,
  • Currently receiving an evidence-based PTSD treatment (exposure-based or cognitive processing therapy)
  • Currently receiving couples therapy or family therapy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

138 participants in 2 patient groups

Structured Approach Therapy
Experimental group
Description:
Couple-Based Intervention called Structured Approach Therapy provides skills training to couple so they can reduce PTSD.
Treatment:
Behavioral: Structured Approach Therapy
PTSD Family Education
Active Comparator group
Description:
Couple-Based Education called PTSD Family Education teaches couple about PTSD symptoms, related problems, and treatment.
Treatment:
Other: PTSD Family Education

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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