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Completed

NCT Number: NCT00640445

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

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

VA Medical Center

Minneapolis, Minnesota, 55417, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Expressive writing

Behavioral

In EW, people are asked to write about their deepest thoughts and feelings surrounding a significant life event for 20 minutes a day for 4 days

Control Writing

Behavioral

Those assigned to control writing conditions are asked to describe factual information for 20 minutes a day for 4 days.

Primary outcomes

  1. PTSD symptoms

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

  2. Hostility

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

  3. Psychological distress

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

  4. Physical symptoms

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

  5. Reintegration difficulty

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

  6. Social support

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

  7. Life satisfaction

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

Secondary outcomes

  1. Emotion and causal word use in participants' essays

    Time frame: Intervention Sessions (up to 4 sessions post-baseline for participants assigned to a writing condition)

  2. Employment status

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

Sponsors and collaborators

Lead sponsor

Minneapolis Veterans Affairs Medical Center

Fed

Collaborators

  • US Department of Veterans Affairs
  • United States Department of Defense

Registry information

Official study title

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

Acronym: M2C

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 21, 2008
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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