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Sponsors and Collaborators: |
Department of Defense Department of Veterans Affairs |
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Information provided by: | Minneapolis Veterans Affairs Medical Center |
ClinicalTrials.gov Identifier: | NCT00640445 |
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 |
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Posttraumatic Stress Disorder |
Behavioral: Expressive Writing (EW) Behavioral: Control Writing (CW) Behavioral: Treatment as Usual |
Phase II Phase III |
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 |
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 |
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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.
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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
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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.
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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.
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3: No Intervention
Treatment As Usual
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Behavioral: Treatment as Usual
No intervention control group
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Ages Eligible for Study: | 19 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nina A Sayer, PhD | 612-467-4623 | nina.sayer@med.va.gov |
United States, Minnesota | |
VA Medical Center | |
Minneapolis, Minnesota, United States, 55417 |
Principal Investigator: | Nina A Sayer, PhD | Minneapolis Veterans Affairs Medical Center |
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 |
Clinical Trial Combat Disorders PTSD |
Internet-Based Intervention Mental Health Services Post-deployment Reintegration |
Anxiety Disorders Combat Disorders Mental Disorders |
Stress Disorders, Post-Traumatic Stress Stress Disorders, Traumatic |
Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic |