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

NCT ID: NCT00640445

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2013-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Expressive Writing

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Control Writing

Intervention Type: BEHAVIORAL

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

No Writing Control

Treatment As Usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Control Writing

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

Minneapolis Veterans Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

Nina A. Sayer

Associate Director, CCDOR; Research Director, PTBRI QUERI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nina A Sayer, PhD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Veterans Affairs Medical Center

Locations

VA Medical Center

Minneapolis, Minnesota, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 24913102 (View on PubMed)

Other Identifiers

PT074432

Identifier Type: -

Identifier Source: org_study_id