Treatments for Insomnia: Mediators, Moderators and Quality of Life

Not Recruiting

Trial ID: NCT02117388


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

Stanford Investigator(s)

Clete A. Kushida, MD, PhD
Clete A. Kushida, MD, PhD

Professor of Psychiatry and Behavioral Sciences (Sleep Medicine)

Rachel Manber, PhD
Rachel Manber, PhD

Professor of Psychiatry and Behavioral Sciences (General Psychiatry and Psychology-Adult)


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

   - 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

   - 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


behavioral: Sleep Restriction

behavioral: Cognitive Behavioral Therapy

behavioral: Combined Therapy

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305