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Military to Civilian: Trial of an Intervention to Promote Postdeployment Reintegration (M2C)
This study is not yet open for participant recruitment.
Verified by Minneapolis Veterans Affairs Medical Center, April 2009
First Received: March 18, 2008   Last Updated: April 9, 2009   History of Changes
Sponsors and Collaborators: Department of Defense
Department of Veterans Affairs
Information provided by: Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00640445
  Purpose

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 nine 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.


Condition Intervention Phase
Posttraumatic Stress Disorder
Behavioral: Expressive Writing (EW)
Behavioral: Control Writing (CW)
Behavioral: Treatment as Usual
Phase II
Phase III

MedlinePlus related topics: Post-Traumatic Stress Disorder
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Factorial Assignment, Efficacy Study
Official Title: Military to Civilian: RCT of an Intervention to Promote Postdeployment Reintegration

Further study details as provided by Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • Psychological symptoms (PTSD, depression, hostility, distress), psychosocial functioning, life satisfaction [ Time Frame: Baseline (Session 1) and follow-up sessions at 3 months (Session 6) and 9 months (Session 7) post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Emotion and causal word use in participants' essays [ Time Frame: Extracted from participant essays written during Sessions 2-5 (among participants assigned to writing conditions) ] [ Designated as safety issue: No ]

Estimated Enrollment: 1152
Study Start Date: July 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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.
Behavioral: Expressive Writing (EW)
In EW, people are asked to write about their deepest thoughts and feelings surrounding a significant life event usually for 20 minutes a day for 3 to 4 consecutive days
2: Active Comparator
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.
Behavioral: Control Writing (CW)
Those assigned to control writing conditions are typically asked to describe factual information about themselves or their life for 20 minutes a day for 3 to 4 consecutive days.
3: No Intervention
Treatment As Usual
Behavioral: Treatment as Usual
No intervention control group

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Veteran from current wars in Iraq and Afghanistan
  • At least some difficulty transitioning from soldier to civilian
  • At least 3 months post-discharge
  • Access to computer with internet
  • Email address
  • Available to participate for up to 40 minutes per session
  • Interested in participation
  • Understand procedures and consent

Exclusion Criteria:

  • Significant suicidal ideation
  • Severe Depression
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00640445

Contacts
Contact: Nina A Sayer, PhD 612-467-4623 nina.sayer@med.va.gov

Locations
United States, Minnesota
VA Medical Center
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Investigators
Principal Investigator: Nina A Sayer, PhD Minneapolis Veterans Affairs Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: VA Medical Center ( Nina A. Sayer )
Study ID Numbers: PT074432
Study First Received: March 18, 2008
Last Updated: April 9, 2009
ClinicalTrials.gov Identifier: NCT00640445     History of Changes
Health Authority: United States: Federal Government

Keywords provided by Minneapolis Veterans Affairs Medical Center:
Clinical Trial
Combat Disorders
PTSD
Internet-Based Intervention
Mental Health Services
Post-deployment Reintegration

Study placed in the following topic categories:
Anxiety Disorders
Combat Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on May 06, 2009