Clinical trial NCT00640445: Military to Civilian: Trial of an Intervention to Promote Postdeployment Reintegration
Official title: Military to Civilian: RCT of an Intervention to Promote Postdeployment Reintegration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Posttraumatic Stress Disorder
Keywords: Clinical Trial
Combat Disorders
PTSD
Internet-Based Intervention
Mental Health Services
Post-deployment Reintegration
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: United States Department of Defense
name: US Department of Veterans Affairs
First posted: 2008-03-21
Enrollment: 1292
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: PTSD symptoms
timeFrame: Baseline, 3-month, 6-month
measure: Hostility
timeFrame: Baseline, 3-month, 6-month
measure: Psychological distress
timeFrame: Baseline, 3-month, 6-month
measure: Physical symptoms
timeFrame: Baseline, 3-month, 6-month
measure: Reintegration difficulty
timeFrame: Baseline, 3-month, 6-month
measure: Social support
timeFrame: Baseline, 3-month, 6-month
measure: Life satisfaction
timeFrame: Baseline, 3-month, 6-month
Secondary outcomes:
measure: Emotion and causal word use in participants' essays
timeFrame: Intervention Sessions (up to 4 sessions post-baseline for participants assigned to a writing condition)
measure: Employment status
timeFrame: Baseline, 3-month, 6-month
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: VA Medical Center
state: Minnesota
Study officials:
affiliation: Minneapolis Veterans Affairs Medical Center
name: Nina A Sayer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.