Two Contrasting Interventions for Sleep Management

Completed · Phase 2/Phase 3

Conditions studied: Primary Insomnia, Secondary Insomnia

In brief

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.

Key facts

Study ID: NCT01804036
Run by: University of Utah
People needed: 72
Starts: 2013-03-01
Expected to finish: 2016-11-01
Last updated by the study team: 2017-03-30

Who can join

Age: 17 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

Evans Army Community Hospital — Colorado Springs, Colorado, United States
University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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