Treatments for Insomnia: Mediators, Moderators and Quality of Life

Completed · Not applicable

Conditions studied: Insomnia

In brief

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).

Key facts

Study ID

NCT02117388

Run by

Palo Alto Veterans Institute for Research

People needed

128

Starts

2013-09-01

Expected to finish

2019-08-23

Last updated by the study team

2019-09-20

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA Palo Alto Health Care System — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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