Primary Insomnia Clinical Trial
Official title:
A Pilot Study of Two Contrasting Intervention Programs for Sleep Management
Verified date | April 2015 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | July 2015 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 17 Years to 40 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Evans Army Community Hospital | Colorado Springs | Colorado |
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah | Evans Army Community Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in subjective measures of sleep using Medical Outcomes Study -Sleep Scale, from baseline to 3 months | Medical Outcomes Study - sleep scale. A 12-item validated questionnaire evaluating sleep outcomes over the past 7 days. | Baseline, Weekly, Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up | No |
Primary | Change in Insomnia Severity Index, from baseline to 3 months | Insomnia Severity Index | Baseline, Weekly, Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up | No |
Primary | Change in subjective measures of sleep using a sleep diary, from baseline to 3 months | Sleep Diary - 7 days of data collection | Baseline, during treatment (Week 2), Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up | No |
Secondary | PTSD Check List (PCL) - Military (PCL-M) | The PCL-M is a well-validated 17-item self-report measure to assess PTSD severity among military personnel; both male and female, to assess military-related PTSD. Reliability evidence is very good. Items are based on DSM criteria (DSM-IV criteria for the latest version) and are rated on a 5-point Likert-type scale that allows the derivation of a quantifiable total score. | Baseline, Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up | No |
Secondary | Center for Epidemiologic Studies Depression Scale (CES-D) | The CES-D is one of the most common validated screening tests for helping an individual to determine his or her depression quotient. The 20-item test measures depressive feelings and behaviors during the past week. | Baseline, Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up | No |
Secondary | Mindfulness Assessment (Five-facet Mindfulness Questionnaire; FFMQ) | This is a validated questionnaire which tracks how facets of mindfulness may develop over time. It has 39 items and divides into 5 factors representing the various aspects of mindfulness. | Baseline, Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up | No |
Secondary | Connor-Davidson Resilience Scale (CD-RISC) | One of the few well-validated measures of resilience is the Connor-Davidson Resilience Scale (CD-RISC), comprising 25 items. | Baseline, Two weeks post MBB treatment/one week post Zolpidem treatment, 2 month follow up | No |
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