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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Nina A. Sayer, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00640445
First received: March 18, 2008
Last updated: July 1, 2014
Last verified: July 2014
  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 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.


Condition Intervention Phase
Posttraumatic Stress Disorder
Behavioral: Expressive Writing
Behavioral: Control Writing
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
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:
  • PTSD symptoms [ Time Frame: Baseline, 3-month, 6-month ] [ Designated as safety issue: No ]
  • Hostility [ Time Frame: Baseline, 3-month, 6-month ] [ Designated as safety issue: No ]
  • Psychological distress [ Time Frame: Baseline, 3-month, 6-month ] [ Designated as safety issue: No ]
  • Physical symptoms [ Time Frame: Baseline, 3-month, 6-month ] [ Designated as safety issue: No ]
  • Reintegration difficulty [ Time Frame: Baseline, 3-month, 6-month ] [ Designated as safety issue: No ]
  • Social support [ Time Frame: Baseline, 3-month, 6-month ] [ Designated as safety issue: No ]
  • Life satisfaction [ Time Frame: Baseline, 3-month, 6-month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • Employment status [ Time Frame: Baseline, 3-month, 6-month ] [ Designated as safety issue: No ]

Enrollment: 1292
Study Start Date: June 2011
Estimated Study Completion Date: August 2015
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Expressive Writing
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
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
Active Comparator: Control Writing
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
Those assigned to control writing conditions are asked to describe factual information for 20 minutes a day for 4 days.
No Intervention: No Writing Control
Treatment As Usual

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640445

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

Additional Information:
Publications:
Responsible Party: Nina A. Sayer, Associate Director, CCDOR; Research Director, PTBRI QUERI, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00640445     History of Changes
Other Study ID Numbers: PT074432
Study First Received: March 18, 2008
Last Updated: July 1, 2014
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

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

ClinicalTrials.gov processed this record on September 18, 2014