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Clinical Trials/NCT00640445
NCT00640445
Completed
Phase 2

Military to Civilian: RCT of an Intervention to Promote Postdeployment Reintegration

Minneapolis Veterans Affairs Medical Center1 site in 1 country1,292 target enrollmentJune 2011

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Posttraumatic Stress Disorder
Sponsor
Minneapolis Veterans Affairs Medical Center
Enrollment
1292
Locations
1
Primary Endpoint
PTSD symptoms
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Veterans returning from combat deployments face the interrelated challenges of processing their combat experiences and transitioning back to civilian life. Unfortunately, many veterans wait years or decades before seeking help for post-deployment problems, if they seek it at all. This study seeks to determine whether Internet-Based Expressive Writing (IB-EW), a brief, low-cost, easily disseminated, and resource-efficient intervention, can reduce psychological symptoms and improve functioning among Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) veterans as they navigate this transition, while also attempting to reduce barriers to help-seeking. Expressive Writing, a highly private, readily accessible, and non-stigmatizing intervention, has a strong evidence-base in civilian populations, but its efficacy in combat veterans has not been tested. This study therefore seeks to test the efficacy of Expressive Writing in a veteran population while further enhancing its accessibility by delivering it over the internet (Internet-Based Expressive Writing; IB-EW). This study will comprise a randomized controlled trial with three conditions: (a) Internet-Based Expressive Writing, (b) Internet-Based Control Writing, and (c) No Writing/Treatment As Usual, with a total of 1152 OIF/OEF veterans randomized across these groups. Expressive Writing participants will write with feeling about their transition from being a soldier to being a civilian; Control Writing participants will write factually about the information needs of new veterans; and Treatment as Usual participants will complete the assessments but not engage in any writing assignments. Participants will complete standardized self-report measures of psychological symptoms, psychosocial functioning, and life satisfaction at baseline (Session 1) and at three months (Session 6) and six months (Session 7) post-intervention. Participants in writing conditions will write for 20 minutes on four consecutive days (Sessions 2-5) following completion of baseline measures (participants in the TAU condition will not complete Sessions 2-5). The study will also attempt to identify individual difference characteristics related to the efficacy of the treatment, to see who may be most likely to benefit from the treatment. Analyses will primarily entail multivariate analyses of variance. Power is adequate to detect even a small effect.

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
September 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Sponsor
Minneapolis Veterans Affairs Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Nina A. Sayer

Associate Director, CCDOR; Research Director, PTBRI QUERI

Minneapolis Veterans Affairs Medical Center

Eligibility Criteria

Inclusion Criteria

  • Veteran from current wars in Iraq and Afghanistan
  • At least a little difficulty transitioning from soldier to civilian
  • Access to computer with internet
  • Provide valid contact information
  • Available to participate for up to 40 minutes per session
  • Interested in participation
  • Understand procedures and consent
  • Note: participants are recruited by random selection from the target population

Exclusion Criteria

  • Severe depression

Outcomes

Primary Outcomes

PTSD symptoms

Time Frame: Baseline, 3-month, 6-month

Physical symptoms

Time Frame: Baseline, 3-month, 6-month

Social support

Time Frame: Baseline, 3-month, 6-month

Life satisfaction

Time Frame: Baseline, 3-month, 6-month

Hostility

Time Frame: Baseline, 3-month, 6-month

Psychological distress

Time Frame: Baseline, 3-month, 6-month

Reintegration difficulty

Time Frame: Baseline, 3-month, 6-month

Secondary Outcomes

  • Employment status(Baseline, 3-month, 6-month)
  • Emotion and causal word use in participants' essays(Intervention Sessions (up to 4 sessions post-baseline for participants assigned to a writing condition))

Study Sites (1)

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