Status:
COMPLETED
Two Contrasting Interventions for Sleep Management
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Evans Army Community Hospital
Conditions:
Primary Insomnia
Secondary Insomnia
Eligibility:
All Genders
17-40 years
Phase:
PHASE2
PHASE3
Brief 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 wh...
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 an...
Eligibility Criteria
Inclusion
- primary insomnia
- secondary insomnia
- requiring sleep medication (Zolpidem) for a three-week trial.
- active duty military service member stationed at Fort Carson.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01804036
Start Date
March 1 2013
End Date
November 1 2016
Last Update
March 30 2017
Active Locations (2)
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1
Evans Army Community Hospital
Colorado Springs, Colorado, United States, 80913
2
University of Utah
Salt Lake City, Utah, United States, 84108