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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

Tracking Information
First Submitted Date  ICMJE February 28, 2013
First Posted Date  ICMJE March 5, 2013
Results First Submitted Date  ICMJE August 8, 2016
Results First Posted Date  ICMJE March 30, 2017
Last Update Posted Date March 30, 2017
Study Start Date  ICMJE March 2013
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 4, 2013)
  • Change in subjective measures of sleep using Medical Outcomes Study -Sleep Scale, from baseline to 3 months [ Time Frame: Baseline, Weekly, Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up ]
    Medical Outcomes Study - sleep scale. A 12-item validated questionnaire evaluating sleep outcomes over the past 7 days.
  • Change in Insomnia Severity Index, from baseline to 3 months [ Time Frame: Baseline, Weekly, Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up ]
    Insomnia Severity Index
  • Change in subjective measures of sleep using a sleep diary, from baseline to 3 months [ Time Frame: Baseline, during treatment (Week 2), Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up ]
    Sleep Diary - 7 days of data collection
Change History Complete list of historical versions of study NCT01804036 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2013)
  • PTSD Check List (PCL) - Military (PCL-M) [ Time Frame: Baseline, Two weeks post MBB treatment/one week post Zolpidem treatment, 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 the latest version) and are rated on a 5-point Likert-type scale that allows the derivation of a quantifiable total score.
  • Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Baseline, Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up ]
    The CES-D is one of the most common 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.
  • Mindfulness Assessment (Five-facet Mindfulness Questionnaire; FFMQ) [ Time Frame: Baseline, Two weeks post MBB treatment/one week post Zolpidem treatment, 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.
  • Connor-Davidson Resilience Scale (CD-RISC) [ Time Frame: Baseline, Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up ]
    One of the few well-validated measures of resilience is the Connor-Davidson Resilience Scale (CD-RISC), comprising 25 items.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Two Contrasting Interventions for Sleep Management
Official Title  ICMJE A Pilot Study of Two Contrasting Intervention Programs for Sleep Management
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Primary Insomnia
  • Secondary Insomnia
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Zolpidem (Ambien) Treatment
    A three week treatment of Zolpidem
    Intervention: Drug: Zolpidem
  • Experimental: Mind-Body Bridging
    An awareness training program using mindfulness-based techniques.
    Intervention: Behavioral: Mind-Body Bridging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2017)
72
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2013)
60
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01804036
Other Study ID Numbers  ICMJE IRBNet-193532-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yoshio Nakamura, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE Evans Army Community Hospital
Investigators  ICMJE
Principal Investigator: Yoshio Nakamura, PhD University of Utah
PRS Account University of Utah
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP