Clinical Benefits of a Novel Sleep-focused Mind-body Program on Gulf War Illness (GWI) Symptoms
This study is currently recruiting participants.
Verified March 2013 by University of Utah
Sponsor:
University of Utah
Collaborators:
VA Salt Lake City Health Care System
Information provided by (Responsible Party):
Yoshio Nakamura, University of Utah
ClinicalTrials.gov Identifier:
NCT01543997
First received: February 27, 2012
Last updated: March 4, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to investigate clinical benefits of a novel sleep-focused mind-body program on Gulf War Illness (GWI) symptoms.
| Condition | Intervention | Phase |
|---|---|---|
|
Sleep Disturbance Persian Gulf War Syndrome in Veteran |
Behavioral: Mind-Body Bridging Program Behavioral: Supportive Education |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Investigating Clinical Benefits of a Novel Sleep-focused Mind-body Program on Gulf War Illness (GWI) Symptoms: An Exploratory Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by University of Utah:
Primary Outcome Measures:
- Change from baseline in the measure of the Medical Outcomes Study-Sleep Scale [ Time Frame: Week1, Week2, Week 3, Week 4, Week 15 ] [ Designated as safety issue: No ]
- Change from baseline in the measure of the Sleep Diary [ Time Frame: Week2, Week 4, Week 15 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pain [ Time Frame: Pre (Baseline), Post (Week4), Follow-up (Week 15) ] [ Designated as safety issue: No ]Multidimensional Pain Inventory Pain Scale
- Fatigue [ Time Frame: Pre (Baseline), Post (Week4), Follow-up (Week 15) ] [ Designated as safety issue: No ]Multidimensional Fatigue Inventory
- Cognitive functioning [ Time Frame: Pre (Baseline), Post (Week4), Follow-up (Week 15) ] [ Designated as safety issue: No ]Cognitive Failures Questionnaire
- Mindfulness [ Time Frame: Pre (Baseline), Weekly for 3 weeks, Post (Week4), Follow-up (Week 15) ] [ Designated as safety issue: No ]5-factor M questionnaire
- Health-related quality of life [ Time Frame: Pre (Baseline), Post (Week4), Follow-up (Week 15) ] [ Designated as safety issue: No ]Medical Outcomes Study Short Form-36
- PTSD [ Time Frame: Pre (Baseline), Post (Week4), Follow-up (Week 15) ] [ Designated as safety issue: No ]PTSD Check List-Military (PCL-M)
- Depression [ Time Frame: Pre (Baseline), Post (Week4), Follow-up (Week 15) ] [ Designated as safety issue: No ]Center of Epidemiological Study-Depression Scale
- Psychological symptoms [ Time Frame: Pre (Baseline), Post (Week4), Follow-up (Week 15) ] [ Designated as safety issue: No ]Brief Symptom Inventory 18
| Estimated Enrollment: | 72 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Behavioral: Mind-Body Bridging Program
Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
Other Name: MBBP
|
|
Active Comparator: 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.
|
Behavioral: Supportive Education
This intervention will provide educational lectures on disability, sleep hygiene, and current research on depression and nondirective, supportive discussions about these topics.
Other Name: SED
|
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).
Eligibility| Ages Eligible for Study: | 38 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543997
Contacts
| Contact: Yuri Kida | 801-585-7697 | yuri.kida@hsc.utah.edu |
Locations
| United States, Utah | |
| VA SLC Health Care System | Recruiting |
| Salt Lake City, Utah, United States, 84148 | |
| Pain Research Center | Active, not recruiting |
| Salt Lake City, Utah, United States, 84108 | |
Sponsors and Collaborators
University of Utah
VA Salt Lake City Health Care System
Investigators
| Principal Investigator: | Yoshio Nakamura, Ph.D. | University of Utah |
More Information
No publications provided
| Responsible Party: | Yoshio Nakamura, Research Assistant Professor, University of Utah |
| ClinicalTrials.gov Identifier: | NCT01543997 History of Changes |
| Other Study ID Numbers: | IRB00049003 |
| Study First Received: | February 27, 2012 |
| Last Updated: | March 4, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Additional relevant MeSH terms:
|
Sleep Disorders Dyssomnias Parasomnias Persian Gulf Syndrome Nervous System Diseases |
Neurologic Manifestations Signs and Symptoms Mental Disorders Occupational Diseases |
ClinicalTrials.gov processed this record on May 19, 2013