Two Contrasting Interventions for Sleep Management
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- primary insomnia
- secondary insomnia
- requiring sleep medication (Zolpidem) for a three-week trial.
- active duty military service member stationed at Fort Carson.
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
72 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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