Trial Search Results

Treatments for Insomnia: Mediators, Moderators and Quality of Life

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).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Palo Alto Veterans Institute for Research

Collaborator: National Institute of Mental Health (NIMH)


  • Behavioral: Sleep Restriction
  • Behavioral: Cognitive Behavioral Therapy
  • Behavioral: Combined Therapy




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 (‚Č• 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

Ages Eligible for Study

60 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting