NCT01804036

Two Contrasting Interventions for Sleep Management

A Pilot Study of Two Contrasting Intervention Programs for Sleep Management

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 17 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Insomnia
• Secondary Insomnia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-03-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2013-03-05
• Last updated: 2017-03-30
• Results posted: 2017-03-30

Locations

2 sites across 1 country: United States