Clinical Benefits of a Novel Sleep-focused Mind-body Program on Gulf War Illness (GWI) Symptoms

November 16, 2016 updated by: Yoshio Nakamura, University of Utah

Investigating Clinical Benefits of a Novel Sleep-focused Mind-body Program on Gulf War Illness (GWI) Symptoms: An Exploratory Randomized Controlled Trial

The purpose of this study is to investigate clinical benefits of a novel sleep-focused mind-body program on Gulf War Illness (GWI) symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized study investigates whether two treatment conditions:Mind-Body Bridging (MBB) and Supportive Education (SED) are effective in improving sleep disturbance and self-reported indicators of other co-morbid symptoms in veterans with GWI. The two treatment conditions will each comprise 3 sessions of 2 hr. duration and conducted over 3 consecutive weeks (Week 1-3).

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • VA SLC Health Care System
      • Salt Lake City, Utah, United States, 84108
        • Pain Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Veteran from First Gulf War
  • Suffering from sleep disturbance

  • Has other chronic symptoms of Gulf War Illness:

    • fatigue
    • chronic headaches
    • joint/muscle pain
    • cognitive difficulties
    • memory/concentration problems
    • shortness of breath
    • gastrointestinal symptoms

Exclusion Criteria:

  • terminally ill
  • a highly unstable medical or psychiatric condition
  • Parkinson disease
  • dementia of any cause
  • Nocturia
  • delayed/advanced sleep phase syndrome
  • Narcolepsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mind-Body Bridging Program
The Mind-Body Bridging Program (MBBP) is an awareness training program (ATP)to help individuals improve their health condition and attain a state of well-being. Bridging is the primary technique that facilitates the healing process, by bringing one back to the present moment to experience thoughts, emotions and physical sensations. Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
Behavioral: Mind-Body Bridging Program
Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
Other Names:
  • MBBP
ACTIVE_COMPARATOR: Supportive Education
Supportive Education program will provide educational lectures on disability, sleep hygiene, and current research on depression and non-directive, supportive discussions about these topics.
Behavioral: Supportive Education
This intervention will provide educational lectures on disability, sleep hygiene, and current research on depression and nondirective, supportive discussions about these topics.
Other Names:
  • SED

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the measure of the Medical Outcomes Study-Sleep Scale
Time Frame: Week1, Week2, Week 3, Week 4, Week 15
Week1, Week2, Week 3, Week 4, Week 15
Change from baseline in the measure of the Sleep Diary
Time Frame: Week2, Week 4, Week 15
Week2, Week 4, Week 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: Pre (Baseline), Post (Week4), Follow-up (Week 15)
Multidimensional Pain Inventory Pain Scale
Pre (Baseline), Post (Week4), Follow-up (Week 15)
Fatigue
Time Frame: Pre (Baseline), Post (Week4), Follow-up (Week 15)
Multidimensional Fatigue Inventory
Pre (Baseline), Post (Week4), Follow-up (Week 15)
Cognitive functioning
Time Frame: Pre (Baseline), Post (Week4), Follow-up (Week 15)
Cognitive Failures Questionnaire
Pre (Baseline), Post (Week4), Follow-up (Week 15)
Mindfulness
Time Frame: Pre (Baseline), Weekly for 3 weeks, Post (Week4), Follow-up (Week 15)
5-factor M questionnaire
Pre (Baseline), Weekly for 3 weeks, Post (Week4), Follow-up (Week 15)
Health-related quality of life
Time Frame: Pre (Baseline), Post (Week4), Follow-up (Week 15)
Medical Outcomes Study Short Form-36
Pre (Baseline), Post (Week4), Follow-up (Week 15)
PTSD
Time Frame: Pre (Baseline), Post (Week4), Follow-up (Week 15)
PTSD Check List-Military (PCL-M)
Pre (Baseline), Post (Week4), Follow-up (Week 15)
Depression
Time Frame: Pre (Baseline), Post (Week4), Follow-up (Week 15)
Center of Epidemiological Study-Depression Scale
Pre (Baseline), Post (Week4), Follow-up (Week 15)
Psychological symptoms
Time Frame: Pre (Baseline), Post (Week4), Follow-up (Week 15)
Brief Symptom Inventory 18
Pre (Baseline), Post (Week4), Follow-up (Week 15)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

United States Department of Defense
VA Salt Lake City Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

February 27, 2012

First Submitted That Met QC Criteria

March 2, 2012

First Posted (ESTIMATE)

March 5, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00049003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep Disturbance

Clinical Trials on Mind-Body Bridging Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe