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Completed

NCT Number: NCT01543997

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

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

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Key information

Conditions

Sleep Disturbance Mental Disorders Nervous System Diseases Parasomnias Persian Gulf War Syndrome in Veteran Sleep Wake Disorders

Age range

38 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pain Research Center, Salt Lake City, Utah, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mind-Body Bridging Program

Behavioral

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

Other names: MBBP

Supportive Education

Behavioral

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

Primary outcomes

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

    Time frame: Week1, Week2, Week 3, Week 4, Week 15

  2. Change from baseline in the measure of the Sleep Diary

    Time frame: Week2, Week 4, Week 15

Secondary outcomes

  1. Pain

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

    Multidimensional Pain Inventory Pain Scale

  2. Fatigue

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

    Multidimensional Fatigue Inventory

  3. Cognitive functioning

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

    Cognitive Failures Questionnaire

  4. Mindfulness

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

    5-factor M questionnaire

  5. Health-related quality of life

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

    Medical Outcomes Study Short Form-36

  6. PTSD

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

    PTSD Check List-Military (PCL-M)

  7. Depression

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

    Center of Epidemiological Study-Depression Scale

  8. Psychological symptoms

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

    Brief Symptom Inventory 18

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Mar 5, 2012
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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