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

Phase 2

Completed

• Conditions: Sleep Disturbance; Persian Gulf War Syndrome in Veteran
• Interventions: Behavioral: Supportive Education; Behavioral: Mind-Body Bridging Program

• Registration Number: NCT01543997
• Lead Sponsor: University of Utah

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).

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-27
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-05
• Primary Completion: 2015-03
• Study Completion: 2016-05
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supportive Education	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.
Mind-Body Bridging Program	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline in the measure of the Sleep Diary	Week2, Week 4, Week 15
Change from baseline in the measure of the Medical Outcomes Study-Sleep Scale	Week1, Week2, Week 3, Week 4, Week 15

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Pain Research Center; 🇺🇸 Salt Lake City, Utah, United States

VA SLC Health Care System; 🇺🇸 Salt Lake City, Utah, United States