Two Contrasting Interventions for Sleep Management

NCT01804036 | Completed Phase 2 Results

• 1 other identifier: IRBNet-193532-1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Primary Insomnia; Secondary Insomnia

Outcome Measures

Primary Outcomes (10)

• 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.

  Baseline, 1-week follow up

• 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.

  Baseline, 2 month follow up

• 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.

  Baseline, 1-week follow up

• 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.

  Baseline, 2 month follow up

• 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.

  Baseline, 1-week follow up

• 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.

  Baseline, 2 month follow up

• 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.

  Baseline, 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.

  Baseline, 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.

  Baseline, 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.

  Baseline, 2 month follow up

Secondary Outcomes (4)

• 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

Study Arms (2)

Zolpidem (Ambien) Treatment

ACTIVE COMPARATOR

A three week treatment of Zolpidem

Drug: Zolpidem

Mind-Body Bridging

EXPERIMENTAL

An awareness training program using mindfulness-based techniques.

Behavioral: Mind-Body Bridging

Interventions

Zolpidem DRUG

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.

Also known as: Ambien

Zolpidem (Ambien) Treatment

Mind-Body Bridging BEHAVIORAL

An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session

Also known as: Awareness Training

Mind-Body Bridging

Eligibility Criteria

• Age: 17 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• primary insomnia
• secondary insomnia
• requiring sleep medication (Zolpidem) for a three-week trial.
• active duty military service member stationed at Fort Carson.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: lead
• Evans Army Community Hospital: collaborator

Study Sites (2)

Evans Army Community Hospital

Colorado Springs, Colorado, 80913, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Yoshio Nakamura, PhD
• Organization: University of Utah

yn5@utah.edu

801-585-7690

Study Officials

• Yoshio Nakamura, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: March 5, 2013
• Study Start: March 1, 2013
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 30, 2017
• Results First Posted: March 30, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)