search
Back to results

Two Contrasting Interventions for Sleep Management

Primary Purpose

Primary Insomnia, Secondary Insomnia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Zolpidem
Mind-Body Bridging
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Insomnia

Eligibility Criteria

17 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Evans Army Community Hospital
  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Zolpidem (Ambien) Treatment

Mind-Body Bridging

Arm Description

A three week treatment of Zolpidem

An awareness training program using mindfulness-based techniques.

Outcomes

Primary Outcome Measures

Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 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
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
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
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
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
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
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
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
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
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

PTSD Check List (PCL) - Military (PCL-M)
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)
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)
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)
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.

Full Information

First Posted
February 28, 2013
Last Updated
February 10, 2017
Sponsor
University of Utah
Collaborators
Evans Army Community Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01804036
Brief Title
Two Contrasting Interventions for Sleep Management
Official Title
A Pilot Study of Two Contrasting Intervention Programs for Sleep Management
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
Evans Army Community Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia, Secondary Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zolpidem (Ambien) Treatment
Arm Type
Active Comparator
Arm Description
A three week treatment of Zolpidem
Arm Title
Mind-Body Bridging
Arm Type
Experimental
Arm Description
An awareness training program using mindfulness-based techniques.
Intervention Type
Drug
Intervention Name(s)
Zolpidem
Other Intervention Name(s)
Ambien
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mind-Body Bridging
Other Intervention Name(s)
Awareness Training
Intervention Description
An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session
Primary Outcome Measure Information:
Title
Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 1-week Follow-up
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
Title
Change in Subjective Measures of Sleep Using Medical Outcomes Study -Sleep Scale, From Baseline at 2 Month Follow-up
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
Title
Change in Insomnia Severity Index, From Baseline at 1-week Follow-up
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
Title
Change in Insomnia Severity Index, From Baseline at 2 Month Follow-up
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
Title
Change in Total Sleep Time Using a Sleep Diary, From Baseline at 1-week Follow-up
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
Title
Change in Total Sleep Time Using a Sleep Diary, From Baseline at 2 Month Follow-up
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
Title
Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 1-week Follow-up
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
Title
Change in Sleep Onset Latency Using a Sleep Diary, From Baseline at 2 Month Follow-up
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
Title
Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 1-week Follow-up
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
Title
Change in Waking After Sleep Onset Using a Sleep Diary, From Baseline at 2 Month Follow-up
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
Secondary Outcome Measure Information:
Title
PTSD Check List (PCL) - Military (PCL-M)
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
Title
Center for Epidemiologic Studies Depression Scale (CES-D)
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
Title
Connor-Davidson Resilience Scale (CD-RISC)
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
Title
Mindfulness Assessment (Five-facet Mindfulness Questionnaire; FFMQ)
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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 enrolled in another study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshio Nakamura, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evans Army Community Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80913
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Two Contrasting Interventions for Sleep Management

We'll reach out to this number within 24 hrs