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Treatments for Insomnia: Mediators, Moderators and Quality of Life

Trial ID or NCT#

NCT02117388

Status

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: Yes

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

View All Criteria

Investigator(s)

Jerome Yesavage

Clete A. Kushida, MD, PhD, FAASM

Sleep specialist, Neurologist

Professor of Psychiatry and Behavioral Sciences at the Stanford University Medical Center

Rachel Manber, PhD

Sleep specialist, Pediatric sleep specialist, Psychologist

Professor of Psychiatry and Behavioral Sciences (General Psychiatry and Psychology-Adult) at the Stanford University Medical Center

CONTACT

SPECTRUM

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View on ClinicalTrials.gov

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