Treatments for Insomnia: Mediators, Moderators and Quality of Life
Trial ID or NCT#
NCT02117388
Status
NOT RECRUITING
Purpose
The purpose of this study is to evaluate the relative efficacy and effectiveness of specific components of cognitive behavioral therapies for insomnia: sleep restriction (SR) and cognitive therapy (CT) in comparison to combined SR and CT (SR+CT).
Official Title
Treatments for Insomnia: Mediators, Moderators and Quality of Life
Eligibility Criteria
Ages Eligible for Study: Older than 60 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
- * Males or females of any racial or ethnic group, aged 60 years old or older* Independent living (not in nursing home, etc.)* English-speaking* Subjective complaint of insomnia associated with daytime impairment or distress* DSM 5 (Diagnostic and Statistical Manual V) diagnosis of insomnia* Score \>10 on the Insomnia Severity Indexa* Must live within 40 miles of Stanford University
Exclusion Criteria:
- * Montreal Cognitive Assessment Scale \<20* Apnea-hypopnea index \>10 or Periodic limb movement associated arousals \> 5 per hour* Use of medication specifically prescribed for sleep and unwilling or unable to discontinue \> one week prior to baseline data collection.* Acute or unstable chronic illness: including but not limited to insulin dependent diabetes (adult onset diabetes, controlled with oral medications or diet is acceptable); uncontrolled thyroid disease, kidney, prostate or bladder conditions causing excessively frequent urination (\> 3 times per night); medically unstable congestive heart failure, angina, other severe cardiac illness as defined by treatment regimen changes in the prior 3 months; stroke with serious sequelae; cancer if \< 1 year since end of treatment; asthma, emphysema, or other severe respiratory diseases uncontrolled with medications; conditions associated with chronic pain such as fibromyalgia; and neurological disorders such as Alzheimer's disease, Parkinson's disease and unstable epilepsy as defined by treatment regimen changes in the prior 3 months.* Use of CNS (central nervous system) active medications that would significantly impact sleep or alertness is allowed as long as the dose, timing, and formulation are stable (\> 4 weeks).* Excessive caffeine consumption (≥ three cups per day), excessive alcohol consumption (\> 14 drinks per week or \> 4 drinks per occasion), or illicit substances (by self-report).* Major psychiatric diagnosis on Axis I of DSM-IV as tested by the Mini International Neuropsychiatric Interview (Version 5.0).* Lives more than 40 miles from Stanford University
Investigator(s)
Jerome Yesavage
RachelÌýManber, PhD
Sleep specialist,
Pediatric sleep specialist,
Psychologist
Professor of Psychiatry and Behavioral Sciences (General Psychiatry and Psychology-Adult)
Clete A. Kushida, MD, PhD
Sleep specialist,
Neurologist
Professor of Psychiatry and Behavioral Sciences (Sleep Medicine)
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