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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01231711
Recruitment Status : Completed
First Posted : November 1, 2010
Last Update Posted : November 1, 2010
Rise Consulting, LLC
McCormick Foundation
Information provided by:
Prevail Health Solutions, LLC

Brief 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).

Condition or disease Intervention/treatment Phase
Depression Post-Traumatic Stress Disorder Functional Status Behavioral: Vets Prevail Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Other Name: Warriors Prevail

Primary Outcome Measures :
  1. Center for Epidemiologic Studies Depression Scale 10 (CES-D 10) [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
    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.

Secondary Outcome Measures :
  1. Post Traumatic Stress Disorder Checklist-Military (PCL-M) [ Time Frame: baseline, week 4, week 8, week 12 ]
    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.

  2. 12-Item Short Form Health Survey (SF-12) [ Time Frame: baseline, week 4, week 8, week 12 ]
    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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • >=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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01231711

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United States, Illinois
Prevail Health Solutions
Chicago, Illinois, United States, 60661
Sponsors and Collaborators
Prevail Health Solutions, LLC
Rise Consulting, LLC
McCormick Foundation
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Principal Investigator: Benjamin VanVoorhees, MD, MPH Rise Consulting, LLC
Study Director: Brock K Hokenson, MBA Prevail Health Solutions
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Responsible Party: Brock Hokenson, Operations Officer, Prevail Health Solutions, LLC Identifier: NCT01231711    
Other Study ID Numbers: 24633-1
First Posted: November 1, 2010    Key Record Dates
Last Update Posted: November 1, 2010
Last Verified: October 2010
Keywords provided by Prevail Health Solutions, LLC:
post traumatic stress syndrome
functional status
mental health self-efficacy
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Mental Disorders
Trauma and Stressor Related Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs