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

NCT01231711 | Completed Phase 1

• 1 other identifier: 24633-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Depression; Post-Traumatic Stress Disorder; Functional Status

Keywords

depression; post traumatic stress syndrome; functional status; veteran; military; stigma; mental health self-efficacy

Outcome Measures

Primary Outcomes (1)

• Center for Epidemiologic Studies Depression Scale 10 (CES-D 10)

  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.

  baseline, 4 weeks, 8 weeks, 12 weeks

Secondary Outcomes (2)

• Post Traumatic Stress Disorder Checklist-Military (PCL-M)

  baseline, week 4, week 8, week 12

• 12-Item Short Form Health Survey (SF-12)

  baseline, week 4, week 8, week 12

Study Arms (1)

Vets Prevail

EXPERIMENTAL

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

Interventions

Vets Prevail BEHAVIORAL

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.

Also known as: Warriors Prevail

Vets Prevail

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Prevail Health Solutions, LLC: lead
• Rise Consulting, LLC: collaborator
• McCormick Foundation: collaborator

Study Sites (1)

Prevail Health Solutions

Chicago, Illinois, 60661, United States

Location

MeSH Terms

Conditions

Depression; Stress Disorders, Post-Traumatic; Combat Disorders; Social Stigma

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Social Behavior

Study Officials

• Benjamin VanVoorhees, MD, MPH

  Rise Consulting, LLC

  PRINCIPAL INVESTIGATOR

• Brock K Hokenson, MBA

  Prevail Health Solutions

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: November 1, 2010
• Study Start: September 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 1, 2010

Record last verified: 2010-10

Locations

US (1)