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

Posttraumatic Stress Disorder Clinical Trial

Official title: Military to Civilian: RCT of an Intervention to Promote Postdeployment Reintegration

Status Completed

Clinical Trial 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 (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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

• NCT number: NCT00640445
• Study type: Interventional
• Source: Minneapolis Veterans Affairs Medical Center
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: June 2011
• Completion date: September 2013