CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 72 enrolled
Drug / intervention
Zolpidem +1 moredrug
Likely dose
Zolpidem 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01804036
NCT01804036Phase 3Completed

A Pilot Study of Two Contrasting Intervention Programs for Sleep Management

University of Utah·interventional·Posted Mar 5, 2013·Updated Mar 30, 2017

In Brief

A Phase 3 clinical trial evaluating Zolpidem and Mind-Body Bridging for Primary Insomnia and Secondary Insomnia. Completed, enrolled 72 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 5, 2013
Enrollment StartMar 1, 2013
Primary CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 13.3 years ago

Interventions

Zolpidemdrug

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 Bridgingbehavioral

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