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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Utah
Sponsor:
Collaborators:
VA Salt Lake City Health Care System
Information provided by (Responsible Party):
Yoshio Nakamura, University of Utah
ClinicalTrials.gov Identifier:
NCT01543997
First received: February 27, 2012
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Sleep Disturbance
Persian Gulf War Syndrome in Veteran
Behavioral: Mind-Body Bridging Program
Behavioral: Supportive Education
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigating Clinical Benefits of a Novel Sleep-focused Mind-body Program on Gulf War Illness (GWI) Symptoms: An Exploratory Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Change from baseline in the measure of the Medical Outcomes Study-Sleep Scale [ Time Frame: Week1, Week2, Week 3, Week 4, Week 15 ] [ Designated as safety issue: No ]
  • Change from baseline in the measure of the Sleep Diary [ Time Frame: Week2, Week 4, Week 15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain [ Time Frame: Pre (Baseline), Post (Week4), Follow-up (Week 15) ] [ Designated as safety issue: No ]
    Multidimensional Pain Inventory Pain Scale

  • Fatigue [ Time Frame: Pre (Baseline), Post (Week4), Follow-up (Week 15) ] [ Designated as safety issue: No ]
    Multidimensional Fatigue Inventory

  • Cognitive functioning [ Time Frame: Pre (Baseline), Post (Week4), Follow-up (Week 15) ] [ Designated as safety issue: No ]
    Cognitive Failures Questionnaire

  • Mindfulness [ Time Frame: Pre (Baseline), Weekly for 3 weeks, Post (Week4), Follow-up (Week 15) ] [ Designated as safety issue: No ]
    5-factor M questionnaire

  • Health-related quality of life [ Time Frame: Pre (Baseline), Post (Week4), Follow-up (Week 15) ] [ Designated as safety issue: No ]
    Medical Outcomes Study Short Form-36

  • PTSD [ Time Frame: Pre (Baseline), Post (Week4), Follow-up (Week 15) ] [ Designated as safety issue: No ]
    PTSD Check List-Military (PCL-M)

  • Depression [ Time Frame: Pre (Baseline), Post (Week4), Follow-up (Week 15) ] [ Designated as safety issue: No ]
    Center of Epidemiological Study-Depression Scale

  • Psychological symptoms [ Time Frame: Pre (Baseline), Post (Week4), Follow-up (Week 15) ] [ Designated as safety issue: No ]
    Brief Symptom Inventory 18


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: SED

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).

  Eligibility

Ages Eligible for Study:   38 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01543997

Contacts
Contact: Megan Varner 801-581-6579 megan.varner@utah.edu
Contact: Yuri Kida 801-585-7697 yuri.kida@hsc.utah.edu

Locations
United States, Utah
VA SLC Health Care System Recruiting
Salt Lake City, Utah, United States, 84148
Pain Research Center Active, not recruiting
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
VA Salt Lake City Health Care System
Investigators
Principal Investigator: Yoshio Nakamura, Ph.D. University of Utah
  More Information

No publications provided

Responsible Party: Yoshio Nakamura, Research Assistant Professor, University of Utah
ClinicalTrials.gov Identifier: NCT01543997     History of Changes
Other Study ID Numbers: IRB00049003
Study First Received: February 27, 2012
Last Updated: February 13, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Sleep Disorders
Dyssomnias
Parasomnias
Persian Gulf Syndrome
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Occupational Diseases

ClinicalTrials.gov processed this record on July 28, 2014