Trial Outcomes & Findings for Two Contrasting Interventions for Sleep Management (NCT NCT01804036)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

72 participants

Primary outcome timeframe

Baseline, 1-week follow up

Results posted on

2017-03-30

Participant Flow

In Mind-Body Bridging, 41 participants consented, but one participant did not provide baseline assessment data; consequently, 40 Mind-Body Bridging participants' baseline data were included in the analyses.

Participant milestones

Participant milestones
Measure	Zolpidem (Ambien) Treatment A three week treatment of Zolpidem Zolpidem: Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed.	Mind-Body Bridging An awareness training program using mindfulness-based techniques. Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session
Overall Study STARTED	31	41
Overall Study COMPLETED	18	21
Overall Study NOT COMPLETED	13	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Two Contrasting Interventions for Sleep Management

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zolpidem (Ambien) Treatment n=31 Participants A three week treatment of Zolpidem 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.	Mind-Body Bridging n=40 Participants An awareness training program using mindfulness-based techniques. Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session	Total n=71 Participants Total of all reporting groups
Age, Continuous	29.9 years STANDARD_DEVIATION 8.2 • n=5 Participants	30.1 years STANDARD_DEVIATION 6.9 • n=7 Participants	30.0 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex/Gender, Customized Males	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants
Sex/Gender, Customized Females	25 participants n=5 Participants	35 participants n=7 Participants	60 participants n=5 Participants
Sex/Gender, Customized Not Provided	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Zolpidem (Ambien) Treatment n=31 Participants A three week treatment of Zolpidem Zolpidem: Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed.	Mind-Body Bridging n=40 Participants An awareness training program using mindfulness-based techniques. Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session
Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 1-week Follow-up	15.8 units on a scale Interval 9.1 to 22.4	16.1 units on a scale Interval 9.3 to 22.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Zolpidem (Ambien) Treatment n=31 Participants A three week treatment of Zolpidem Zolpidem: Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed.	Mind-Body Bridging n=40 Participants An awareness training program using mindfulness-based techniques. Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session
Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 2 Month Follow-up	29.38 units on a scale Interval 22.0 to 36.75	21.04 units on a scale Interval 13.97 to 28.11

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Zolpidem (Ambien) Treatment n=31 Participants A three week treatment of Zolpidem Zolpidem: Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed.	Mind-Body Bridging n=40 Participants An awareness training program using mindfulness-based techniques. Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session
Change in Insomnia Severity Index, From Baseline at 1-week Follow-up	4.3 units on a scale Interval 2.2 to 6.3	4.0 units on a scale Interval 2.0 to 5.9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Zolpidem (Ambien) Treatment n=31 Participants A three week treatment of Zolpidem Zolpidem: Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed.	Mind-Body Bridging n=40 Participants An awareness training program using mindfulness-based techniques. Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session
Change in Insomnia Severity Index, From Baseline at 2 Month Follow-up	9.34 units on a scale Interval 7.0 to 11.72	6.38 units on a scale Interval 4.11 to 8.66

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Zolpidem (Ambien) Treatment n=31 Participants A three week treatment of Zolpidem Zolpidem: Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed.	Mind-Body Bridging n=40 Participants An awareness training program using mindfulness-based techniques. Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session
Change in Total Sleep Time Using a Sleep Diary, From Baseline at 1-week Follow-up	69.6 minutes Interval 36.0 to 103.1	38.3 minutes Interval 4.8 to 71.9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Zolpidem (Ambien) Treatment n=31 Participants A three week treatment of Zolpidem Zolpidem: Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed.	Mind-Body Bridging n=40 Participants An awareness training program using mindfulness-based techniques. Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session
Change in Total Sleep Time Using a Sleep Diary, From Baseline at 2 Month Follow-up	74.14 minutes Interval 33.8 to 114.5	29.9 minutes Interval -10.4 to 70.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Zolpidem (Ambien) Treatment n=31 Participants A three week treatment of Zolpidem Zolpidem: Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed.	Mind-Body Bridging n=40 Participants An awareness training program using mindfulness-based techniques. Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session
Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 1-week Follow-up	-5.9 minutes Interval -17.2 to 5.4	-11.1 minutes Interval -22.6 to 0.4

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Zolpidem (Ambien) Treatment n=31 Participants A three week treatment of Zolpidem Zolpidem: Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed.	Mind-Body Bridging n=40 Participants An awareness training program using mindfulness-based techniques. Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session
Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 2 Month Follow-up	-7.5 minutes Interval -21.4 to 6.3	-13.7 minutes Interval -27.6 to 0.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Zolpidem (Ambien) Treatment n=31 Participants A three week treatment of Zolpidem Zolpidem: Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed.	Mind-Body Bridging n=40 Participants An awareness training program using mindfulness-based techniques. Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session
Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 1-week Follow-up	-4.3 minutes Interval -8.8 to 0.2	-4.0 minutes Interval -8.5 to 0.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Zolpidem (Ambien) Treatment n=31 Participants A three week treatment of Zolpidem Zolpidem: Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed.	Mind-Body Bridging n=40 Participants An awareness training program using mindfulness-based techniques. Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session
Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 2 Month Follow-up	-4.8 minutes Interval -10.4 to 0.9	-4.5 minutes Interval -10.2 to 1.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Zolpidem (Ambien) Treatment n=31 Participants A three week treatment of Zolpidem Zolpidem: Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed.	Mind-Body Bridging n=40 Participants An awareness training program using mindfulness-based techniques. Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session
PTSD Check List (PCL) - Military (PCL-M)	35.9 units on a scale Interval 31.5 to 40.3	38.0 units on a scale Interval 34.1 to 41.8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Zolpidem (Ambien) Treatment n=31 Participants A three week treatment of Zolpidem Zolpidem: Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed.	Mind-Body Bridging n=40 Participants An awareness training program using mindfulness-based techniques. Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session
Center for Epidemiologic Studies Depression Scale (CES-D)	19.5 units on a scale Interval 16.8 to 22.1	24.5 units on a scale Interval 22.2 to 26.9

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Zolpidem (Ambien) Treatment n=31 Participants A three week treatment of Zolpidem Zolpidem: Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed.	Mind-Body Bridging n=40 Participants An awareness training program using mindfulness-based techniques. Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session
Connor-Davidson Resilience Scale (CD-RISC)	72.9 units on a scale Interval 68.0 to 77.7	62.3 units on a scale Interval 58.0 to 66.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Zolpidem (Ambien) Treatment n=31 Participants A three week treatment of Zolpidem Zolpidem: Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed.	Mind-Body Bridging n=40 Participants An awareness training program using mindfulness-based techniques. Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session
Mindfulness Assessment (Five-facet Mindfulness Questionnaire; FFMQ)	126.9 units on a scale Interval 120.0 to 133.8	120.1 units on a scale Interval 114.3 to 125.8

Adverse Events

Zolpidem (Ambien) Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mind-Body Bridging

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yoshio Nakamura, PhD

University of Utah

Phone: 801-585-7690

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place