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

Posttraumatic Stress Disorder Clinical Trial

— M2C  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00640445
• Other study ID #: PT074432
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 18, 2008
• Last updated: September 21, 2015
• Start date: June 2011
• Est. completion date: September 2013

Study information

• Verified date: September 2015
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1292
• Est. completion date: September 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 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

Intervention

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

Locations

Country	Name	City	State
United States	VA Medical Center	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Minneapolis Veterans Affairs Medical Center	United States Department of Defense, VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & 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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD symptoms		Baseline, 3-month, 6-month	No
Primary	Hostility		Baseline, 3-month, 6-month	No
Primary	Psychological distress		Baseline, 3-month, 6-month	No
Primary	Physical symptoms		Baseline, 3-month, 6-month	No
Primary	Reintegration difficulty		Baseline, 3-month, 6-month	No
Primary	Social support		Baseline, 3-month, 6-month	No
Primary	Life satisfaction		Baseline, 3-month, 6-month	No
Secondary	Emotion and causal word use in participants' essays		Intervention Sessions (up to 4 sessions post-baseline for participants assigned to a writing condition)	No
Secondary	Employment status		Baseline, 3-month, 6-month	No

External Links

•   Information on Expressive Writing presented by pioneer of this intervention, James Pennebaker