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
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, Post-Traumatic
Stress Disorders, Traumatic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Anxiety Disorders

ClinicalTrials.gov processed this record on April 17, 2014