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Trial record 63 of 117 for:    ZOLPIDEM AND AIDS

Two Contrasting Interventions for Sleep Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Primary Insomnia
Secondary Insomnia
Interventions Drug: Zolpidem
Behavioral: Mind-Body Bridging
Enrollment 72
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Zolpidem (Ambien) Treatment Mind-Body Bridging
Hide Arm/Group Description

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.

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

Period Title: Overall Study
Started 31 41
Completed 18 21
Not Completed 13 20
Arm/Group Title Zolpidem (Ambien) Treatment Mind-Body Bridging Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 31 40 71
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 40 participants 71 participants
29.9  (8.2) 30.1  (6.9) 30.0  (7.4)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants 40 participants 71 participants
Males 5 5 10
Females 25 35 60
Not Provided 1 0 1
1.Primary Outcome
Title Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 1-week Follow-up
Hide Description 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.
Time Frame Baseline, 1-week follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem (Ambien) Treatment Mind-Body Bridging
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 31 40
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
15.8
(9.1 to 22.4)
16.1
(9.3 to 22.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem (Ambien) Treatment, Mind-Body Bridging
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 2 Month Follow-up
Hide Description 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.
Time Frame Baseline, 2 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem (Ambien) Treatment Mind-Body Bridging
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 31 40
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
29.38
(22.0 to 36.75)
21.04
(13.97 to 28.11)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem (Ambien) Treatment, Mind-Body Bridging
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Primary Outcome
Title Change in Insomnia Severity Index, From Baseline at 1-week Follow-up
Hide Description 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.
Time Frame Baseline, 1-week follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem (Ambien) Treatment Mind-Body Bridging
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 31 40
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
4.3
(2.2 to 6.3)
4.0
(2.0 to 5.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem (Ambien) Treatment, Mind-Body Bridging
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Primary Outcome
Title Change in Insomnia Severity Index, From Baseline at 2 Month Follow-up
Hide Description 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.
Time Frame Baseline, 2 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem (Ambien) Treatment Mind-Body Bridging
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 31 40
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
9.34
(7.0 to 11.72)
6.38
(4.11 to 8.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem (Ambien) Treatment, Mind-Body Bridging
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Primary Outcome
Title Change in Total Sleep Time Using a Sleep Diary, From Baseline at 1-week Follow-up
Hide Description 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.
Time Frame Baseline, 1-week follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem (Ambien) Treatment Mind-Body Bridging
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 31 40
Mean (95% Confidence Interval)
Unit of Measure: minutes
69.6
(36.0 to 103.1)
38.3
(4.8 to 71.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem (Ambien) Treatment, Mind-Body Bridging
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Primary Outcome
Title Change in Total Sleep Time Using a Sleep Diary, From Baseline at 2 Month Follow-up
Hide Description 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.
Time Frame Baseline, 2 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem (Ambien) Treatment Mind-Body Bridging
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 31 40
Mean (95% Confidence Interval)
Unit of Measure: minutes
74.14
(33.8 to 114.5)
29.9
(-10.4 to 70.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem (Ambien) Treatment, Mind-Body Bridging
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
7.Primary Outcome
Title Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 1-week Follow-up
Hide Description 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.
Time Frame Baseline, 1-week follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem (Ambien) Treatment Mind-Body Bridging
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 31 40
Mean (95% Confidence Interval)
Unit of Measure: minutes
-5.9
(-17.2 to 5.4)
-11.1
(-22.6 to 0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem (Ambien) Treatment, Mind-Body Bridging
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
8.Primary Outcome
Title Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 2 Month Follow-up
Hide Description 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.
Time Frame Baseline, 2 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem (Ambien) Treatment Mind-Body Bridging
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 31 40
Mean (95% Confidence Interval)
Unit of Measure: minutes
-7.5
(-21.4 to 6.3)
-13.7
(-27.6 to 0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem (Ambien) Treatment, Mind-Body Bridging
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
9.Primary Outcome
Title Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 1-week Follow-up
Hide Description 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.
Time Frame Baseline, 1-week follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem (Ambien) Treatment Mind-Body Bridging
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 31 40
Mean (95% Confidence Interval)
Unit of Measure: minutes
-4.3
(-8.8 to 0.2)
-4.0
(-8.5 to 0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem (Ambien) Treatment, Mind-Body Bridging
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.94
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
10.Primary Outcome
Title Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 2 Month Follow-up
Hide Description 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.
Time Frame Baseline, 2 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem (Ambien) Treatment Mind-Body Bridging
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 31 40
Mean (95% Confidence Interval)
Unit of Measure: minutes
-4.8
(-10.4 to 0.9)
-4.5
(-10.2 to 1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem (Ambien) Treatment, Mind-Body Bridging
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
11.Secondary Outcome
Title PTSD Check List (PCL) - Military (PCL-M)
Hide Description 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.
Time Frame Baseline, 2 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem (Ambien) Treatment Mind-Body Bridging
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 31 40
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
35.9
(31.5 to 40.3)
38.0
(34.1 to 41.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem (Ambien) Treatment, Mind-Body Bridging
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
12.Secondary Outcome
Title Center for Epidemiologic Studies Depression Scale (CES-D)
Hide Description 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.
Time Frame Baseline, 2 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem (Ambien) Treatment Mind-Body Bridging
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 31 40
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
19.5
(16.8 to 22.1)
24.5
(22.2 to 26.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem (Ambien) Treatment, Mind-Body Bridging
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
13.Secondary Outcome
Title Connor-Davidson Resilience Scale (CD-RISC)
Hide Description 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.
Time Frame Baseline, 2 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem (Ambien) Treatment Mind-Body Bridging
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 31 40
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
72.9
(68.0 to 77.7)
62.3
(58.0 to 66.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem (Ambien) Treatment, Mind-Body Bridging
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
14.Secondary Outcome
Title Mindfulness Assessment (Five-facet Mindfulness Questionnaire; FFMQ)
Hide Description 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.
Time Frame Baseline, 2 month follow up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Zolpidem (Ambien) Treatment Mind-Body Bridging
Hide Arm/Group Description:

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.

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 Number of Participants Analyzed 31 40
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
126.9
(120.0 to 133.8)
120.1
(114.3 to 125.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Zolpidem (Ambien) Treatment, Mind-Body Bridging
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Zolpidem (Ambien) Treatment Mind-Body Bridging
Hide Arm/Group Description

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.

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

All-Cause Mortality
Zolpidem (Ambien) Treatment Mind-Body Bridging
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Zolpidem (Ambien) Treatment Mind-Body Bridging
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/41 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Zolpidem (Ambien) Treatment Mind-Body Bridging
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/41 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Yoshio Nakamura, PhD
Organization: University of Utah
Phone: 801-585-7690
EMail: yn5@utah.edu
Responsible Party: Yoshio Nakamura, University of Utah
ClinicalTrials.gov Identifier: NCT01804036     History of Changes
Other Study ID Numbers: IRBNet-193532-1
First Submitted: February 28, 2013
First Posted: March 5, 2013
Results First Submitted: August 8, 2016
Results First Posted: March 30, 2017
Last Update Posted: March 30, 2017