Military to Civilian: Trial of an Intervention to Promote Postdeployment Reintegration (M2C)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Psychological symptoms (PTSD, depression, hostility, distress) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Psychological symptoms (PTSD, depression, hostility, distress) [ Time Frame: 3-mo follow-up ] [ Designated as safety issue: No ]
- Psychological symptoms (PTSD, depression, hostility, distress) [ Time Frame: 6-mo follow-up ] [ Designated as safety issue: No ]
- Psychosocial functioning and life satisfaction [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Psychosocial functioning and life satisfaction [ Time Frame: 3-mo follow-up ] [ Designated as safety issue: No ]
- Psychosocial functioning and life satisfaction [ Time Frame: 6-mo follow-up ] [ Designated as safety issue: No ]
- 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 ]
| Enrollment: | 1292 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | August 2013 |
| 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 |
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
- 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| United States, Minnesota | |
| VA Medical Center | |
| Minneapolis, Minnesota, United States, 55417 | |
| Principal Investigator: | Nina A Sayer, PhD | Minneapolis Veterans Affairs Medical Center |
More Information
Additional Information:
No publications provided
| 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: | May 2, 2013 |
| 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, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013