A Pilot Study of Two Contrasting Intervention Programs for Sleep Management
Overview
- Phase
- Phase 2
- Intervention
- Zolpidem
- Conditions
- Primary Insomnia
- Sponsor
- University of Utah
- Enrollment
- 72
- Locations
- 2
- Primary Endpoint
- Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 1-week Follow-up
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Yoshio Nakamura
Research Associate Professor
University of Utah
Eligibility 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
Arms & Interventions
Zolpidem (Ambien) Treatment
A three week treatment of Zolpidem
Intervention: Zolpidem
Mind-Body Bridging
An awareness training program using mindfulness-based techniques.
Intervention: Mind-Body Bridging
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- PTSD Check List (PCL) - Military (PCL-M)(Baseline, 2 month follow up)
- Center for Epidemiologic Studies Depression Scale (CES-D)(Baseline, 2 month follow up)
- Connor-Davidson Resilience Scale (CD-RISC)(Baseline, 2 month follow up)
- Mindfulness Assessment (Five-facet Mindfulness Questionnaire; FFMQ)(Baseline, 2 month follow up)