- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01804036
Two Contrasting Interventions for Sleep Management
February 10, 2017 updated by: Yoshio Nakamura, University of Utah
A Pilot Study of Two Contrasting Intervention Programs for Sleep Management
This study will determine whether Mind-Body Bridging (MBB), a mindfulness training program is more effective than a common sleep medication, Zolpidem, in treating insomnia.
It will also investigate whether MBB is additionally beneficial for co-morbid conditions such as stress, PTSD, depression, etc, compared with that of Zolpidem.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Sleep disturbance in active duty military personnel is highly prevalent and contributes to reduced performance of military duties.
Under extreme conditions, army personnel could endanger themselves and their comrades.
Increasingly, non-pharmacological treatments for insomnia are showing promise as complementary and alternative medicine treatments.
Many of these awareness training programs (ATPs) perform as well as, or even better than, medications.
This study will determine whether Mind-Body Bridging (MBB), an ATP that teaches awareness/mindfulness and cognitive skills, is more effective than a common sleep medication, Zolpidem.
The study will also determine whether MBB exhibits additional benefits in co-morbid mental health conditions, including, stress, PTSD, depression, etc, compared with that of Zolpidem.
This will offer soldiers additional treatment options for insomnia in the hope that it will improve both sleep and other common comorbidities.
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Colorado Springs, Colorado, United States, 80913
- Evans Army Community Hospital
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Utah
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Salt Lake City, Utah, United States, 84108
- University of Utah
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years to 40 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- primary insomnia
- secondary insomnia
- requiring sleep medication (Zolpidem) for a three-week trial.
- active duty military service member stationed at Fort Carson.
Exclusion Criteria:
- secondary insomnia to a likely medical condition, such as sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, and other sleep disorders, which are not appropriately treatable with sleep medication.
- treated for sleep problems using sleep medications which include Lunesta, Ambien, Ambien Controlled Release (CR), Seroquel, Trazodone or Remeron
- major psychopathology (i.e., schizophrenia)
- severe depression within the past 90 days
- suicidal ideation within the past 90 days
- psychiatrically hospitalized within the past 90 days
- uncontrolled hypertension or diabetes
- pregnancy
- previous use of Zolpidem proved to be ineffective or to cause other unwanted side effects
- actively abusing controlled substances
- enrolled in another study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Zolpidem (Ambien) Treatment
A three week treatment of Zolpidem
|
Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed.
Other Names:
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Experimental: Mind-Body Bridging
An awareness training program using mindfulness-based techniques.
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An awareness training program.
One 2 hr class per week for 3 weeks - 2 hours per session
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 1-week Follow-up
Time Frame: Baseline, 1-week follow up
|
Medical Outcomes Study - sleep scale.
A 12-item validated questionnaire evaluating sleep outcomes over the past 7 days.
The subscale Sleep Problems Index - II, is reported, range is 0-100.
The greater the value the worse the sleep problems.
In the present study, the greater the change from baseline the greater the improvement in sleep problems.
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Baseline, 1-week follow up
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Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 2 Month Follow-up
Time Frame: Baseline, 2 month follow up
|
Medical Outcomes Study - sleep scale.
A 12-item validated questionnaire evaluating sleep outcomes over the past 7 days.
The subscale Sleep Problems Index - II, is reported, range is 0-100.
The greater the value the worse the sleep problems.
In the present study, the greater the change from baseline the greater the improvement in sleep problems.
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Baseline, 2 month follow up
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Change in Insomnia Severity Index, From Baseline at 1-week Follow-up
Time Frame: Baseline, 1-week follow up
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Insomnia Severity Index - A 7-item validated questionnaire evaluating severity of insomnia symptoms over the past 7 days.
The total score is reported with a range of 0-28.
The greater the value the greater the insomnia severity.
In the present study, the greater the change from baseline the greater the improvement in insomnia severity.
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Baseline, 1-week follow up
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Change in Insomnia Severity Index, From Baseline at 2 Month Follow-up
Time Frame: Baseline, 2 month follow up
|
Insomnia Severity Index - A 7-item validated questionnaire evaluating severity of insomnia symptoms over the past 7 days.
The total score is reported with a range of 0-28.
The greater the value the greater the insomnia severity.
In the present study, the greater the change from baseline the greater the improvement in insomnia severity.
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Baseline, 2 month follow up
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Change in Total Sleep Time Using a Sleep Diary, From Baseline at 1-week Follow-up
Time Frame: Baseline, 1-week follow up
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Sleep Diary - 7 days of data collection.
Total Sleep Time (TST, in min.):
The amount of time asleep, calculated from the time of falling asleep to waking up.
Range 0 - 24 hr.
The greater the value the more total sleep was obtained.
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Baseline, 1-week follow up
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Change in Total Sleep Time Using a Sleep Diary, From Baseline at 2 Month Follow-up
Time Frame: Baseline, 2 month follow up
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Sleep Diary - 7 days of data collection; Total Sleep Time (TST, in min.):
The amount of time asleep, calculated from the time of falling asleep to waking up.
Range 0 - 24 hr.
The greater the value the more total sleep was obtained.
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Baseline, 2 month follow up
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Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 1-week Follow-up
Time Frame: Baseline, 1-week follow up
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Sleep Diary - 7 days of data collection; Sleep Onset Latency (SOL, in min.):
The time to fall asleep, calculated from the time of turning out the light to falling asleep.
Range 0 - 24 hr.
A negative value reflects an improvement in SOL at the 1-week follow-up.
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Baseline, 1-week follow up
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Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 2 Month Follow-up
Time Frame: Baseline, 2 month follow up
|
Sleep Diary - 7 days of data collection; Sleep Onset Latency (SOL, in min.):
The time to fall asleep, calculated from the time of turning out the light to falling asleep.
Range 0 - 24 hr.
A negative value reflects an improvement in SOL at the 2-month follow-up.
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Baseline, 2 month follow up
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Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 1-week Follow-up
Time Frame: Baseline, 1-week follow up
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Sleep Diary - 7 days of data collection; Waking After Sleep Onset (WASO, in min.):
The duration of awakenings throughout the night, calculated after falling asleep to before the last awakening of waking up and not going back to sleep.
Range 0 - 24 hr.
A negative value reflects improvement in WASO at the 1-week follow-up.
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Baseline, 1-week follow up
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Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 2 Month Follow-up
Time Frame: Baseline, 2 month follow up
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Sleep Diary - 7 days of data collection; Waking After Sleep Onset (WASO, in min.):
The duration of awakenings throughout the night, calculated after falling asleep to before the last awakening of waking up and not going back to sleep.
Range 0 - 24 hr.
A negative value reflects improvement in WASO at the 2-month follow-up.
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Baseline, 2 month follow up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PTSD Check List (PCL) - Military (PCL-M)
Time Frame: Baseline, 2 month follow up
|
The PCL-M is a well-validated 17-item self-report measure to assess PTSD severity among military personnel; both male and female, to assess military-related PTSD.
Reliability evidence is very good.
Items are based on DSM criteria (DSM-IV criteria for this version) and are rated on a 5-point Likert-type scale that allows the derivation of a quantifiable total score.Range is 0-85, the greater the value the worse the PTSD reported symptoms.
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Baseline, 2 month follow up
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Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: Baseline, 2 month follow up
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The CES-D is one of the most commonly validated screening tests for helping an individual to determine his or her depression quotient.
The 20-item test measures depressive feelings and behaviors during the past week.
Each item is summed to obtain a CES-D total score ranging from 0 to 60; higher scores indicate more severe depressive symptoms.
A total score of 16 or higher was identified in early studies as indicative of individuals with depressive illness.
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Baseline, 2 month follow up
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Connor-Davidson Resilience Scale (CD-RISC)
Time Frame: Baseline, 2 month follow up
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One of the few well-validated measures of resilience is the Connor-Davidson Resilience Scale (CD-RISC), comprising 25 items.
All items are summed to obtain a CD-RISC total score ranging from 0-100, with greater total scores indicating greater resilience.
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Baseline, 2 month follow up
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Mindfulness Assessment (Five-facet Mindfulness Questionnaire; FFMQ)
Time Frame: Baseline, 2 month follow up
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This is a validated questionnaire which tracks how facets of mindfulness may develop over time.
It has 39 items and divides into 5 factors representing the various aspects of mindfulness.
The range is 0-195.
The greater the value the greater an individual's mindfulness level.
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Baseline, 2 month follow up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Yoshio Nakamura, PhD, University of Utah
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
February 28, 2013
First Submitted That Met QC Criteria
March 4, 2013
First Posted (Estimate)
March 5, 2013
Study Record Updates
Last Update Posted (Actual)
March 30, 2017
Last Update Submitted That Met QC Criteria
February 10, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Sleep Initiation and Maintenance Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Hypnotics and Sedatives
- GABA Agents
- Sleep Aids, Pharmaceutical
- GABA-A Receptor Agonists
- GABA Agonists
- Zolpidem
Other Study ID Numbers
- IRBNet-193532-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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