Improving Quality-of-life and Depressive Symptoms of Combat Veterans Via Internet-based Intervention
NCT01231711 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2010-11-01
Summary
Background: Current military involvement in Afghanistan (Operation Enduring Freedom - OEF) and Iraq (Operation Iraqi Freedom - OIF) has created unforeseen burdens on the mental health and well-being of US service women and men. Although OEF/OIF service members and veterans are at high risk of developing sub-threshold combat stress and depressive symptoms or full disorders in the post-deployment period, only a small fraction ever receive care. The VETS PREVAIL Intervention, which combines Cognitive-Behavioral-Therapy-based (CBT-based) coping skills training with peer-to-peer support and counseling, was specifically designed to offer the returning OEF/OIF service member or veteran an accessible and confidential first step to care.
Evaluation Study: RISE Consulting, lead by Dr. Benjamin W. Van Voorhees, MD, MPH, was contracted to supervise a pilot study of potential benefit, feasibility and safety of the VETS PREVAIL Intervention. The study would consist of a single group pre/post comparison study of N=50 recent OEF/OIF veterans in the frame work of a phase 1 clinical trial (phase 1). Feasibility (adherence and satisfaction), evidence of clinical benefit would be evaluated through changes in the following clinical self-report measures: i) symptoms of depressed mood (Center for Epidemiologic Studies Depression Scale, CES-D), ii) post traumatic stress disorder (Post Traumatic Stress Disorder Checklist-Military, PCL-M), and iii) functional status (Short Form 12, SF-12), as well as changes in key attitudes toward mental health care seeking (intent to seek treatment, mental health self-efficacy and stigma).
Conditions
- Depression
- Post-Traumatic Stress Disorder
- Functional Status
Interventions
- BEHAVIORAL
-
Vets Prevail
The intervention has two primary components that are both delivered over the Internet: The first component is a structured series of brief peer-to-peer instant messaging "Chats" structured around ensuring effective motivation, engagement, and completion. This component was modeled after Motivational Interviewing (MI) techniques. The peer-to-peer contact was provided by a master's level social worker, as well as by trained and certified combat veterans who completed the Vet-to-Vet counseling certificate program offered by the Depression and Bipolar Support Alliance (DBSA). The second component consists of six 30-minute "e-Learning Lessons" using standard Cognitive Behavioral Therapy (CBT) approaches to reducing depressive and anxiety symptoms and strengthening coping skills.
Sponsors & Collaborators
-
Rise Consulting, LLC
collaborator UNKNOWN -
McCormick Foundation
collaborator UNKNOWN -
Prevail Health Solutions, LLC
lead INDUSTRY
Principal Investigators
-
Benjamin VanVoorhees, MD, MPH · Rise Consulting, LLC
-
Brock K Hokenson, MBA · Prevail Health Solutions
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-09-30
- Primary Completion
- 2010-02-28
- Completion
- 2010-06-30
Countries
- United States
Study Locations
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