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Two Contrasting Interventions for Sleep Management

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ClinicalTrials.gov Identifier: NCT01804036
Recruitment Status : Completed
First Posted : March 5, 2013
Results First Posted : March 30, 2017
Last Update Posted : March 30, 2017
Sponsor:
Collaborator:
Evans Army Community Hospital
Information provided by (Responsible Party):
Yoshio Nakamura, University of Utah

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Primary Insomnia Secondary Insomnia Drug: Zolpidem Behavioral: Mind-Body Bridging Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Two Contrasting Intervention Programs for Sleep Management
Study Start Date : March 2013
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Zolpidem (Ambien) Treatment
A three week treatment of Zolpidem
Drug: 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 Name: Ambien

Experimental: Mind-Body Bridging
An awareness training program using mindfulness-based techniques.
Behavioral: Mind-Body Bridging
An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session
Other Name: Awareness Training




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Change in Insomnia Severity Index, From Baseline at 1-week Follow-up [ Time Frame: Baseline, 1-week 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.

  4. 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.

  5. Change in Total Sleep Time Using a Sleep Diary, From Baseline at 1-week Follow-up [ Time Frame: Baseline, 1-week follow up ]
    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.

  6. Change in Total Sleep Time 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; 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.

  7. Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 1-week Follow-up [ Time Frame: Baseline, 1-week 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 1-week follow-up.

  8. 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.

  9. Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 1-week Follow-up [ Time Frame: Baseline, 1-week follow up ]
    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.

  10. Change in Waking After Sleep Onset 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; 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.


Secondary Outcome Measures :
  1. 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.

  2. Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Baseline, 2 month follow up ]
    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.

  3. Connor-Davidson Resilience Scale (CD-RISC) [ Time Frame: Baseline, 2 month follow up ]
    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.

  4. Mindfulness Assessment (Five-facet Mindfulness Questionnaire; FFMQ) [ Time Frame: Baseline, 2 month follow up ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01804036


Locations
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United States, Colorado
Evans Army Community Hospital
Colorado Springs, Colorado, United States, 80913
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Sponsors and Collaborators
University of Utah
Evans Army Community Hospital
Investigators
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Principal Investigator: Yoshio Nakamura, PhD University of Utah

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Responsible Party: Yoshio Nakamura, Research Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT01804036     History of Changes
Other Study ID Numbers: IRBNet-193532-1
First Posted: March 5, 2013    Key Record Dates
Results First Posted: March 30, 2017
Last Update Posted: March 30, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Zolpidem
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action