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Two Contrasting Interventions for Sleep Management

NCT01804036 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2017-03-30

Study results available
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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

Interventions

DRUG

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.

BEHAVIORAL

Mind-Body Bridging

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

Sponsors & Collaborators

Principal Investigators

  • Yoshio Nakamura, PhD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01804036 on ClinicalTrials.gov