Sleep DisturbancePhase 2NCT01543997
Clinical Benefits of a Novel Sleep-focused Mind-body Program on Gulf War Illness (GWI) Symptoms
A Phase 2 study testing Mind-Body Bridging Program and Supportive Education in people with Sleep Disturbance and Persian Gulf War Syndrome in Veteran, run by University of Utah at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 38 to 80 years
- Conditions the study is for
- Sleep Disturbance, Persian Gulf War Syndrome in Veteran
- What is being tested?
- Mind-Body Bridging Program and Supportive Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to May 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 38 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran from First Gulf War
- Suffering from sleep disturbance
- Has other chronic symptoms of Gulf War Illness:
- fatigue
- chronic headaches
- joint/muscle pain
Show all 10Show fewer
- cognitive difficulties
- memory/concentration problems
- shortness of breath
- gastrointestinal symptoms
Who cannot join
- terminally ill
- a highly unstable medical or psychiatric condition
- Parkinson disease
- dementia of any cause
- Nocturia
- delayed/advanced sleep phase syndrome
- Narcolepsy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pain Research Center
Salt Lake City, Utah, 84108
VA SLC Health Care System
Salt Lake City, Utah, 84148
About this study
Official title: Investigating Clinical Benefits of a Novel Sleep-focused Mind-body Program on Gulf War Illness (GWI) Symptoms: An Exploratory Randomized Controlled Trial
The purpose of this study is to investigate clinical benefits of a novel sleep-focused mind-body program on Gulf War Illness (GWI) symptoms.
Read the 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).
- Being tested
- Mind-Body Bridging Program, Supportive Education
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-Body Bridging ProgramBehavioural
Also called MBBP
Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
Supportive EducationBehavioural
Also called SED
This intervention will provide educational lectures on disability, sleep hygiene, and current research on depression and nondirective, supportive discussions about these topics.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mind-Body Bridging Program |
| 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. Receives: Behavioral: Supportive Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the measure of the Medical Outcomes Study-Sleep Scale
Measured: Week1, Week2, Week 3, Week 4, Week 15
Change from baseline in the measure of the Sleep Diary
Measured: Week2, Week 4, Week 15
Secondary outcomes (8)
Pain
Multidimensional Pain Inventory Pain Scale
Measured: Pre (Baseline), Post (Week4), Follow-up (Week 15)
Fatigue
Multidimensional Fatigue Inventory
Measured: Pre (Baseline), Post (Week4), Follow-up (Week 15)
Cognitive functioning
Cognitive Failures Questionnaire
Measured: Pre (Baseline), Post (Week4), Follow-up (Week 15)
Mindfulness
5-factor M questionnaire
Measured: Pre (Baseline), Weekly for 3 weeks, Post (Week4), Follow-up (Week 15)
Health-related quality of life
Medical Outcomes Study Short Form-36
Measured: Pre (Baseline), Post (Week4), Follow-up (Week 15)
PTSD
PTSD Check List-Military (PCL-M)
Measured: Pre (Baseline), Post (Week4), Follow-up (Week 15)
Depression
Center of Epidemiological Study-Depression Scale
Measured: Pre (Baseline), Post (Week4), Follow-up (Week 15)
Psychological symptoms
Brief Symptom Inventory 18
Measured: Pre (Baseline), Post (Week4), Follow-up (Week 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- VA Salt Lake City Health Care System, United States Department of Defense
- Responsible party
- Principal investigator, Yoshio Nakamura, University of Utah
- Investigators
- Yoshio Nakamura, Ph.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543997
- Sponsor's protocol ID
- IRB00049003
- Status last verified
- Nov 2016
- First submitted
- 27 Feb 2012
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28406803
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Clinical Benefits of a Novel Sleep-focused Mind-body Program on Gulf War Illness (GWI) Symptoms: An Exploratory Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01543997
- Acronym / sponsor ID
- IRB00049003
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- VA Salt Lake City Health Care System, United States Department of Defense
- Study start
- Jan 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mind-Body Bridging Program | Experimental | Behavioral: Mind-Body Bridging ProgramThe 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. |
| Supportive Education | Active comparator | Behavioral: Supportive EducationSupportive Education program will provide educational lectures on disability, sleep hygiene, and current research on depression and non-directive, supportive discussions about these topics. |
Who may qualify
- Ages
- 38 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Veteran from First Gulf War
- Suffering from sleep disturbance
- Has other chronic symptoms of Gulf War Illness:
Key exclusion criteria (7 listed)
- terminally ill
- a highly unstable medical or psychiatric condition
- Parkinson disease
- dementia of any cause
- Nocturia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind-Body Bridging ProgramAlso: MBBPBridging aims to reduce the impact of negative thought patterns that contribute to stress in the body. | Behavioural | Mind-Body Bridging Program |
| Supportive EducationAlso: SEDThis intervention will provide educational lectures on disability, sleep hygiene, and current research on depression and nondirective, supportive discussions about these topics. | Behavioural | Supportive Education |
Primary outcome
Change from baseline in the measure of the Medical Outcomes Study-Sleep Scale
Time frame: Week1, Week2, Week 3, Week 4, Week 15
Change from baseline in the measure of the Sleep Diary
Time frame: Week2, Week 4, Week 15
8 secondary outcomes
Pain
Time frame: Pre (Baseline), Post (Week4), Follow-up (Week 15)
Fatigue
Time frame: Pre (Baseline), Post (Week4), Follow-up (Week 15)
Cognitive functioning
Time frame: Pre (Baseline), Post (Week4), Follow-up (Week 15)
Mindfulness
Time frame: Pre (Baseline), Weekly for 3 weeks, Post (Week4), Follow-up (Week 15)
Health-related quality of life
Time frame: Pre (Baseline), Post (Week4), Follow-up (Week 15)
PTSD
Time frame: Pre (Baseline), Post (Week4), Follow-up (Week 15)
Depression
Time frame: Pre (Baseline), Post (Week4), Follow-up (Week 15)
Psychological symptoms
Time frame: Pre (Baseline), Post (Week4), Follow-up (Week 15)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
- Derived from this study: PubMed 28406803Nakamura 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshio Nakamura, Ph.D. principal investigator
University of Utah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mind-Body Bridging Program and Supportive Education in people with Sleep Disturbance and Persian Gulf War Syndrome in Veteran, run by University of Utah at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the measure of the Medical Outcomes Study-Sleep Scale (time frame: Week1, Week2, Week 3, Week 4, Week 15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01543997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2016.