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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Sleep Disturbance, Persian Gulf War Syndrome in Veteran

Intervention / Treatment
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* Behavioral: Mind-Body Bridging Program
* Behavioral: Supportive Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 38 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mind-Body Bridging Program<br>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<br>* Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.<br>* Other names: MBBP;|
| Active Comparator: Supportive Education<br>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<br>* This intervention will provide educational lectures on disability, sleep hygiene, and current research on depression and nondirective, supportive discussions about these topics.<br>* Other names: SED;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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