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Completed

NCT Number: NCT01804036

Two Contrasting Interventions 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.

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Key information

Conditions

Primary Insomnia Dyssomnias Mental Disorders Nervous System Diseases Secondary Insomnia Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

17 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Evans Army Community Hospital, Colorado Springs, Colorado, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zolpidem

Drug

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: Ambien

Mind-body Bridging

Behavioral

An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session

Other names: Awareness Training

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Evans Army Community Hospital

Registry information

Official study title

A Pilot Study of Two Contrasting Intervention Programs for Sleep Management

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 5, 2013
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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