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

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Expressive Writing
Control Writing
Sponsored by
Minneapolis Veterans Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Clinical Trial, Combat Disorders, PTSD, Internet-Based Intervention, Mental Health Services, Post-deployment Reintegration

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Expressive Writing

Control Writing

No Writing Control

Arm Description

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.

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.

Treatment As Usual

Outcomes

Primary Outcome Measures

PTSD symptoms
Hostility
Psychological distress
Physical symptoms
Reintegration difficulty
Social support
Life satisfaction

Secondary Outcome Measures

Emotion and causal word use in participants' essays
Employment status

Full Information

First Posted
March 18, 2008
Last Updated
September 21, 2015
Sponsor
Minneapolis Veterans Affairs Medical Center
Collaborators
United States Department of Defense, US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00640445
Brief Title
Military to Civilian: Trial of an Intervention to Promote Postdeployment Reintegration
Acronym
M2C
Official Title
Military to Civilian: RCT of an Intervention to Promote Postdeployment Reintegration
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minneapolis Veterans Affairs Medical Center
Collaborators
United States Department of Defense, US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Clinical Trial, Combat Disorders, PTSD, Internet-Based Intervention, Mental Health Services, Post-deployment Reintegration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1292 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Expressive Writing
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Writing
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No Writing Control
Arm Type
No Intervention
Arm Description
Treatment As Usual
Intervention Type
Behavioral
Intervention Name(s)
Expressive Writing
Intervention Description
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
Intervention Name(s)
Control Writing
Intervention Description
Those assigned to control writing conditions are asked to describe factual information for 20 minutes a day for 4 days.
Primary Outcome Measure Information:
Title
PTSD symptoms
Time Frame
Baseline, 3-month, 6-month
Title
Hostility
Time Frame
Baseline, 3-month, 6-month
Title
Psychological distress
Time Frame
Baseline, 3-month, 6-month
Title
Physical symptoms
Time Frame
Baseline, 3-month, 6-month
Title
Reintegration difficulty
Time Frame
Baseline, 3-month, 6-month
Title
Social support
Time Frame
Baseline, 3-month, 6-month
Title
Life satisfaction
Time Frame
Baseline, 3-month, 6-month
Secondary Outcome Measure Information:
Title
Emotion and causal word use in participants' essays
Time Frame
Intervention Sessions (up to 4 sessions post-baseline for participants assigned to a writing condition)
Title
Employment status
Time Frame
Baseline, 3-month, 6-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina A Sayer, PhD
Organizational Affiliation
Minneapolis Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24913102
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.
Results Reference
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Military to Civilian: Trial of an Intervention to Promote Postdeployment Reintegration

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