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

Military to Civilian: RCT 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 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.

Study Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Expressive Writing; Behavioral: Control Writing

• Study Type: Interventional
• Enrollment (Actual): 1292
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PTSD symptoms	Baseline, 3-month, 6-month
Hostility	Baseline, 3-month, 6-month
Psychological distress	Baseline, 3-month, 6-month
Physical symptoms	Baseline, 3-month, 6-month
Reintegration difficulty	Baseline, 3-month, 6-month
Social support	Baseline, 3-month, 6-month
Life satisfaction	Baseline, 3-month, 6-month

Secondary Outcome Measures

Outcome Measure	Time Frame
Emotion and causal word use in participants' essays	Intervention Sessions (up to 4 sessions post-baseline for participants assigned to a writing condition)
Employment status	Baseline, 3-month, 6-month

Collaborators and Investigators

• Sponsor: Minneapolis Veterans Affairs Medical Center
• Collaborators: United States Department of Defense; US Department of Veterans Affairs
• Investigators: Principal Investigator: Nina A Sayer, PhD, Minneapolis Veterans Affairs Medical Center

Publications and helpful links

General Publications

• Sayer NA, Orazem RJ, Noorbaloochi S, Gravely A, Frazier P, Carlson KF, Schnurr PP, Oleson H. Iraq and Afghanistan War Veterans with Reintegration Problems: Differences by Veterans Affairs Healthcare User Status. Adm Policy Ment Health. 2015 Jul;42(4):493-503. doi: 10.1007/s10488-014-0564-2.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: March 18, 2008
• First Submitted That Met QC Criteria: March 18, 2008
• First Posted (Estimate): March 21, 2008

Study Record Updates

• Last Update Posted (Estimate): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 21, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: PTSD; Clinical Trial; Mental Health Services; Combat Disorders; Internet-Based Intervention; Post-deployment Reintegration
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: PT074432