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

NCT00640445 | Completed Phase 2

• 1 other identifier: PT074432
• Study Type: interventional
• Target: 1,292
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posttraumatic Stress Disorder

Keywords

Clinical Trial; Combat Disorders; PTSD; Internet-Based Intervention; Mental Health Services; Post-deployment Reintegration

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• 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

Study Arms (3)

Expressive Writing

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.

Behavioral: Expressive Writing

Control Writing

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.

Behavioral: Control Writing

No Writing Control

NO INTERVENTION

Treatment As Usual

Interventions

Expressive Writing BEHAVIORAL

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

Expressive Writing

Control Writing BEHAVIORAL

Those assigned to control writing conditions are asked to describe factual information for 20 minutes a day for 4 days.

Control Writing

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe depression

Sponsors & Collaborators

• Minneapolis Veterans Affairs Medical Center: lead
• United States Department of Defense: collaborator
• US Department of Veterans Affairs: collaborator

Study Sites (1)

VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (1)

• 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.

  PMID: 24913102 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Combat Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Nina A Sayer, PhD

  Minneapolis Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, CCDOR; Research Director, PTBRI QUERI

Study Record Dates

• First Submitted: March 18, 2008
• First Posted: March 21, 2008
• Study Start: June 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

US (1)