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NCT00640445 · ClinicalTrials.gov registry record · Phase 2
Military to Civilian: Trial of an Intervention to Promote Postdeployment Reintegration
A Phase 2 study, sponsored by Minneapolis Veterans Affairs Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,292
- Enrollment target
NCT00640445 is a Phase 2 study that has completed, run by Minneapolis Veterans Affairs Medical Center. The registered enrollment target is 1,292 participants.
The verdict
NCT00640445, a Phase 2 study, has completed, sponsored by Minneapolis Veterans Affairs Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,292 participants
- Enrollment target
Study Summary
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 (
Interventions
- BEHAVIORAL Expressive Writing
- BEHAVIORAL Control Writing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,292 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00640445
The ClinicalTrials.gov registry entry for NCT00640445 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,292 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Minneapolis Veterans Affairs Medical Center, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Expressive Writing is the first listed.
NCT00640445 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00640445 about?
NCT00640445 is a clinical study titled "Military to Civilian: Trial of an Intervention to Promote Postdeployment Reintegration". 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...
What is the current status of trial NCT00640445?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,292 participants. The study started on 2011-06. Estimated completion is 2013-09.
What interventions are being tested in trial NCT00640445?
The interventions under investigation include: Expressive Writing (BEHAVIORAL), Control Writing (BEHAVIORAL).
Who is sponsoring clinical trial NCT00640445?
This trial is sponsored by Minneapolis Veterans Affairs Medical Center, which has 28 total clinical trials registered on ClinicalTrials.gov.
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