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| Name | Class |
|---|---|
| VA Salt Lake City Health Care System | FED |
| United States Department of Defense | FED |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mind-Body Bridging Program | Behavioral | Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body. |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Multidimensional Pain Inventory Pain Scale | Pre (Baseline), Post (Week4), Follow-up (Week 15) |
| Fatigue | Multidimensional Fatigue Inventory |
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Inclusion Criteria:
Veteran from First Gulf War
Suffering from sleep disturbance
Has other chronic symptoms of Gulf War Illness:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoshio Nakamura, Ph.D. | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pain Research Center | Salt Lake City | Utah | 84108 | United States | ||
| VA SLC Health Care System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28406803 | Derived | 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. |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| 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. |
|
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| 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) |
| Salt Lake City |
| Utah |
| 84148 |
| United States |