NCT01543997

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2012

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 5, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

3.2 years

First QC Date

February 27, 2012

Last Update Submit

November 16, 2016

Conditions

Sleep DisturbancePersian Gulf War Syndrome in Veteran

Outcome Measures

Primary Outcomes (2)

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

    Week1, Week2, Week 3, Week 4, Week 15

  • Change from baseline in the measure of the Sleep Diary

    Week2, Week 4, Week 15

Secondary Outcomes (8)

  • Pain

    Pre (Baseline), Post (Week4), Follow-up (Week 15)

  • Fatigue

    Pre (Baseline), Post (Week4), Follow-up (Week 15)

  • Cognitive functioning

    Pre (Baseline), Post (Week4), Follow-up (Week 15)

  • Mindfulness

    Pre (Baseline), Weekly for 3 weeks, Post (Week4), Follow-up (Week 15)

  • Health-related quality of life

    Pre (Baseline), Post (Week4), Follow-up (Week 15)

  • +3 more secondary outcomes

Study Arms (2)

Mind-Body Bridging Program

EXPERIMENTAL

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

Supportive Education

ACTIVE COMPARATOR

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

Interventions

Mind-Body Bridging ProgramBEHAVIORAL

Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.

Also known as: MBBP
Mind-Body Bridging Program
Supportive EducationBEHAVIORAL

This intervention will provide educational lectures on disability, sleep hygiene, and current research on depression and nondirective, supportive discussions about these topics.

Also known as: SED
Supportive Education

Eligibility Criteria

Age38 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pain Research Center

Salt Lake City, Utah, 84108, United States

Location

VA SLC Health Care System

Salt Lake City, Utah, 84148, United States

Location

Related Publications (1)

  • 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.

    PMID: 28406803DERIVED

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Yoshio Nakamura, Ph.D.

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

February 27, 2012

First Posted

March 5, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2015

Study Completion

May 1, 2016

Last Updated

November 18, 2016

Record last verified: 2016-11

Locations

US(2)