Two Contrasting Interventions for Sleep Management

Phase 2

Completed

• Conditions: Primary Insomnia; Secondary Insomnia
• Interventions: Behavioral: Mind-Body Bridging; Drug: Zolpidem

• Registration Number: NCT01804036
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2013-02-28
• Study Start: 2013-03
• Study First Submitted QC: 2013-03-04
• Study First Posted: 2013-03-05
• Results First Submitted: 2016-08-08
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-10
• Last Update Submitted: 2017-02-10
• Results First Posted: 2017-03-30
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mind-Body Bridging	Mind-Body Bridging	An awareness training program using mindfulness-based techniques.
Zolpidem (Ambien) Treatment	Zolpidem	A three week treatment of Zolpidem

Primary Outcome Measures

Name	Time	Method
Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 1-week Follow-up	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	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	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	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	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	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	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	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	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	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

Name	Time	Method
PTSD Check List (PCL) - Military (PCL-M)	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)	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)	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)	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.

Trial Locations

Locations (2)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Evans Army Community Hospital; 🇺🇸 Colorado Springs, Colorado, United States