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Military to Civilian: Trial of an Intervention to Promote Postdeployment Reintegration (M2C)

M

Minneapolis Veterans Affairs Health Care System (VAHCS)

Status and phase

Completed
Phase 3
Phase 2

Conditions

Posttraumatic Stress Disorder

Treatments

Behavioral: Expressive Writing
Behavioral: Control Writing

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00640445
PT074432

Details and patient eligibility

About

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.

Enrollment

1,292 patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

1,292 participants in 3 patient groups

Expressive Writing
Experimental group
Description:
Participants assigned to the Expressive Writing (EW) condition will write about their deepest thoughts and feelings associated with their experience transitioning from being a soldier to being a civilian for 20 minutes a day for 4 days within a week.
Treatment:
Behavioral: Expressive Writing
Control Writing
Active Comparator group
Description:
Those assigned to control writing condition will write factually about the information needs of veterans transitioning from active duty to civilian status for 20 minutes on 4 days within one week.
Treatment:
Behavioral: Control Writing
No Writing Control
No Intervention group
Description:
Treatment As Usual

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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