Investigating Clinical Benefits of a Novel Sleep-focused Mind-body Program on Gulf War Illness (GWI) Symptoms: An Exploratory Randomized Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Sleep Disturbance
- Sponsor
- University of Utah
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- Change from baseline in the measure of the Sleep Diary
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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).
Investigators
Yoshio Nakamura
Research Associate Professor
University of Utah
Eligibility Criteria
Inclusion Criteria
- •Veteran from First Gulf War
- •Suffering from sleep disturbance
- •Has other chronic symptoms of Gulf War Illness:
- •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
- •delayed/advanced sleep phase syndrome
- •Narcolepsy
Outcomes
Primary Outcomes
Change from baseline in the measure of the Sleep Diary
Time Frame: Week2, Week 4, Week 15
Change from baseline in the measure of the Medical Outcomes Study-Sleep Scale
Time Frame: Week1, Week2, Week 3, Week 4, Week 15
Secondary Outcomes
- 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))
- Depression(Pre (Baseline), Post (Week4), Follow-up (Week 15))
- Psychological symptoms(Pre (Baseline), Post (Week4), Follow-up (Week 15))
- PTSD(Pre (Baseline), Post (Week4), Follow-up (Week 15))