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NCT00515177 · ClinicalTrials.gov registry record · Phase 2
Mindfulness Versus Pharmacotherapy for Chronic Insomnia: A Pilot Study
A Phase 2 study of Primary Insomnia and Chronic Insomnia, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT00515177 is a Phase 2 study of Primary Insomnia and Chronic Insomnia that has completed, run by University of Minnesota. The registered enrollment target is 30 participants, below the 124-participant average among 12 other Primary Insomnia trials with a reported enrollment target (76% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT00515177, a Phase 2 study of Primary Insomnia and Chronic Insomnia, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
Chronic insomnia is a major public health problem that affects about 10% of adults and is associated with serious and distressful health consequences such as depression, anxiety and reduced quality of life. Sleep medications are effective, but side effects, costs and uncertain long term efficacy call for non-pharmacologic alternatives. Mindfulness-Based Stress Reduction (MBSR), a standardized program of training in mindfulness meditation and yoga, is a promising new approach for treating chronic insomnia. MBSR was developed to facilitate adaptation to the stressors of medical illness. It is hypothesized that mindfulness training reduces arousal and unhelpful cognitions that promote and sustain chronic insomnia. The Mindfulness Versus Pharmacotherapy trial (MVP#1) is a pilot study designed to establish the feasibility and determine the optimal design for a full-scale trial comparing MBSR to prescribed sleep medication for treatment of chronic insomnia. For this pilot, we will randomize persons with primary chronic insomnia (actual sample of 30 persons) to 2 groups : 1) MBSR (8-weeks of group instruction followed by 3-months of home practice); and 2) PCT (3 mg of LUNESTA(eszopiclone) nightly for 8-weeks followed by 3-months of "as needed" use). Both groups will have telephone monitoring for side effects, adherence tracking, and objective sleep assessment by actigraphy. The primary outcomes are sleep quality, sleep quantity and insomnia severity assessed by well-validated self-report scales, objective sleep parameters measured by wrist actigraphy, depression and anxiety symptoms, health-related quality of life and workplace productivity. We hypothesize that those in the MBSR group will have improved sleep outcomes. Outcomes will be assessed at 8-weeks (the end of the active intervention phase) and 5 months follow-up. Outcomes will be compared to baseline values and measures reflecting proposed mechanisms of action to determine if clinically important impacts are likely
Conditions Studied
Interventions
- BEHAVIORAL Mindfulness-Based Stress Reduction
- DRUG eszopiclone
Study Locations (2)
Minnesota
- Minnesota Regional Sleep Disorders Center at Hennepin County Medical Center - Minneapolis
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2007-08 |
| Est. Completion | 2009-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00515177
The ClinicalTrials.gov registry entry for NCT00515177 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 124-participant average among 12 other Primary Insomnia trials with a reported enrollment target (76% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Primary Insomnia appearing as the primary indexed condition, and to 2 interventions - of which Mindfulness-Based Stress Reduction is the first listed.
NCT00515177 reports 2 study locations spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT00515177 about?
NCT00515177 is a clinical study titled "Mindfulness Versus Pharmacotherapy for Chronic Insomnia: A Pilot Study". Chronic insomnia is a major public health problem that affects about 10% of adults and is associated with serious and distressful health consequences such as depression, anxiety and reduced quality of life. Sleep medications are effective, but side effects, costs and uncertain long term efficacy cal...
What is the current status of trial NCT00515177?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2007-08. Estimated completion is 2009-06.
What conditions does trial NCT00515177 study?
This clinical trial studies the following conditions: Primary Insomnia, Chronic Insomnia.
What interventions are being tested in trial NCT00515177?
The interventions under investigation include: Mindfulness-Based Stress Reduction (BEHAVIORAL), eszopiclone (DRUG).
Who is sponsoring clinical trial NCT00515177?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00515177 being conducted?
This trial has 2 study locations across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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