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

Primary Purpose

Sleep Disturbance, Persian Gulf War Syndrome in Veteran

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mind-Body Bridging Program
Supportive Education
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbance

Eligibility Criteria

38 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pain Research Center
  • VA SLC Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mind-Body Bridging Program

Supportive Education

Arm Description

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.

Supportive Education program will provide educational lectures on disability, sleep hygiene, and current research on depression and non-directive, supportive discussions about these topics.

Outcomes

Primary Outcome Measures

Change from baseline in the measure of the Medical Outcomes Study-Sleep Scale
Change from baseline in the measure of the Sleep Diary

Secondary Outcome Measures

Pain
Multidimensional Pain Inventory Pain Scale
Fatigue
Multidimensional Fatigue Inventory
Cognitive functioning
Cognitive Failures Questionnaire
Mindfulness
5-factor M questionnaire
Health-related quality of life
Medical Outcomes Study Short Form-36
PTSD
PTSD Check List-Military (PCL-M)
Depression
Center of Epidemiological Study-Depression Scale
Psychological symptoms
Brief Symptom Inventory 18

Full Information

First Posted
February 27, 2012
Last Updated
November 16, 2016
Sponsor
University of Utah
Collaborators
VA Salt Lake City Health Care System, United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT01543997
Brief Title
Clinical Benefits of a Novel Sleep-focused Mind-body Program on Gulf War Illness (GWI) Symptoms
Official Title
Investigating Clinical Benefits of a Novel Sleep-focused Mind-body Program on Gulf War Illness (GWI) Symptoms: An Exploratory Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
VA Salt Lake City Health Care System, United States Department of Defense

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance, Persian Gulf War Syndrome in Veteran

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mind-Body Bridging Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Supportive Education
Arm Type
Active Comparator
Arm Description
Supportive Education program will provide educational lectures on disability, sleep hygiene, and current research on depression and non-directive, supportive discussions about these topics.
Intervention Type
Behavioral
Intervention Name(s)
Mind-Body Bridging Program
Other Intervention Name(s)
MBBP
Intervention Description
Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
Intervention Type
Behavioral
Intervention Name(s)
Supportive Education
Other Intervention Name(s)
SED
Intervention Description
This intervention will provide educational lectures on disability, sleep hygiene, and current research on depression and nondirective, supportive discussions about these topics.
Primary Outcome Measure Information:
Title
Change from baseline in the measure of the Medical Outcomes Study-Sleep Scale
Time Frame
Week1, Week2, Week 3, Week 4, Week 15
Title
Change from baseline in the measure of the Sleep Diary
Time Frame
Week2, Week 4, Week 15
Secondary Outcome Measure Information:
Title
Pain
Description
Multidimensional Pain Inventory Pain Scale
Time Frame
Pre (Baseline), Post (Week4), Follow-up (Week 15)
Title
Fatigue
Description
Multidimensional Fatigue Inventory
Time Frame
Pre (Baseline), Post (Week4), Follow-up (Week 15)
Title
Cognitive functioning
Description
Cognitive Failures Questionnaire
Time Frame
Pre (Baseline), Post (Week4), Follow-up (Week 15)
Title
Mindfulness
Description
5-factor M questionnaire
Time Frame
Pre (Baseline), Weekly for 3 weeks, Post (Week4), Follow-up (Week 15)
Title
Health-related quality of life
Description
Medical Outcomes Study Short Form-36
Time Frame
Pre (Baseline), Post (Week4), Follow-up (Week 15)
Title
PTSD
Description
PTSD Check List-Military (PCL-M)
Time Frame
Pre (Baseline), Post (Week4), Follow-up (Week 15)
Title
Depression
Description
Center of Epidemiological Study-Depression Scale
Time Frame
Pre (Baseline), Post (Week4), Follow-up (Week 15)
Title
Psychological symptoms
Description
Brief Symptom Inventory 18
Time Frame
Pre (Baseline), Post (Week4), Follow-up (Week 15)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
38 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshio Nakamura, Ph.D.
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pain Research Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
VA SLC Health Care System
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28406803
Citation
Nakamura Y, Lipschitz DL, Donaldson GW, Kida Y, Williams SL, Landward R, Glover DW, West G, Tuteja AK. Investigating Clinical Benefits of a Novel Sleep-Focused Mind-Body Program on Gulf War Illness Symptoms: A Randomized Controlled Trial. Psychosom Med. 2017 Jul/Aug;79(6):706-718. doi: 10.1097/PSY.0000000000000469.
Results Reference
derived

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

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