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

This study has been completed.
Sponsor:
Collaborators:
Rise Consulting, LLC
McCormick Foundation
Information provided by:
Prevail Health Solutions, LLC
ClinicalTrials.gov Identifier:
NCT01231711
First received: October 28, 2010
Last updated: October 29, 2010
Last verified: October 2010
  Purpose

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 Intervention Phase
Depression
Post-Traumatic Stress Disorder
Functional Status
Behavioral: Vets Prevail
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Prevail Health Solutions, LLC:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 50
Study Start Date: September 2009
Study Completion Date: June 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Names:
  • Vets Prevail
  • Warriors Prevail

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01231711

Locations
United States, Illinois
Prevail Health Solutions
Chicago, Illinois, United States, 60661
Sponsors and Collaborators
Prevail Health Solutions, LLC
Rise Consulting, LLC
McCormick Foundation
Investigators
Principal Investigator: Benjamin VanVoorhees, MD, MPH Rise Consulting, LLC
Study Director: Brock K Hokenson, MBA Prevail Health Solutions
  More Information

No publications provided

Responsible Party: Brock Hokenson, Operations Officer, Prevail Health Solutions, LLC
ClinicalTrials.gov Identifier: NCT01231711     History of Changes
Other Study ID Numbers: 24633-1
Study First Received: October 28, 2010
Last Updated: October 29, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Prevail Health Solutions, LLC:
depression
post traumatic stress syndrome
functional status
veteran
military
stigma
mental health self-efficacy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on September 30, 2014