Improving Quality-of-life and Depressive Symptoms of Combat Veterans Via Internet-based Intervention

Completed · Phase 1

Conditions studied: Depression, Post-Traumatic Stress Disorder, Functional Status

In brief

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).

Key facts

Study ID

NCT01231711

Run by

Prevail Health Solutions, LLC

People needed

50

Starts

2009-09-01

Expected to finish

2010-06-01

Last updated by the study team

2010-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >=18 years of age
• A veteran of the U.S. military having served in the Iraq or Afghanistan theaters in the last 5 years.
• CES-D(20) score >8
• Access to high-speed internet
• Own a cell phone with text message capability
• speak and read the English language

You may not qualify if…

• psychiatric hospitalizations within past 10 years
• any past suicide attempt
• diagnoses of schizophrenia or bipolar disorder
• CES-D(20) score >36
• discontinued or altered dosage of medication within 10 days prior to enrollment
• score >=2 on the alcohol/drug assessment

Where it is running

• Prevail Health Solutions — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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