Improving Quality-of-life and Depressive Symptoms of Combat Veterans Via Internet-based Intervention
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).
Post-Traumatic Stress Disorder
Behavioral: Vets Prevail
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Improving Quality-of-life and Depressive Symptoms for OEF/OIF Combat Veterans: Assessing the Benefits of Interactive, Internet-based Psychotherapy and Peer-to-peer Support|
- Center for Epidemiologic Studies Depression Scale 10 (CES-D 10) [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: Yes ]The Center for Epidemiologic Studies Depression Scale (CES-D) is one of the most common screening tests for helping an individual to determine his or her depression quotient. The quick self-test measures depressive feelings and behaviours during the past week.
- Post Traumatic Stress Disorder Checklist-Military (PCL-M) [ Time Frame: baseline, week 4, week 8, week 12 ] [ Designated as safety issue: No ]The PTSD Checklist-Military (PCL-M) is a 17-item self-report measure of PTSD symptoms that requires respondents to rate the severity of each symptom during the past 30 days on a five-point ordinal scale. A total PCL-M score was created by summing the item ratings.
- 12-Item Short Form Health Survey (SF-12) [ Time Frame: baseline, week 4, week 8, week 12 ] [ Designated as safety issue: No ]The SF-12 is a generic measure and does not target a specific age or disease group. It is a shorter, valid alternative to the SF-36. The SF-12 is weighted and summed to provide separate scales for an individuals phisical and mental health called the Physical Composite Score (PCS) and Mental Composite Score (MCS).
|Study Start Date:||September 2009|
|Study Completion Date:||June 2010|
|Primary Completion Date:||February 2010 (Final data collection date for primary outcome measure)|
Experimental: Vets Prevail
N=50. Participants were recent veterans (deployed after September 11, 2001) of operations in Iraq and Afghanistan who were experiencing depression/distress symptoms at the time of screening (CES-D > 8) but who were not considered to be inappropriate for a health promotion intervention (CES-D > 35 indicating severe depressed mood or exhibiting self-harm risk).
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01231711
|United States, Illinois|
|Prevail Health Solutions|
|Chicago, Illinois, United States, 60661|
|Principal Investigator:||Benjamin VanVoorhees, MD, MPH||Rise Consulting, LLC|
|Study Director:||Brock K Hokenson, MBA||Prevail Health Solutions|