Treatments for Insomnia: Mediators, Moderators and Quality of Life

As many as one in three older adults may experience insomnia. Older adults are the most
frequent users of hypnotic medications. Although safer, use of even the latest "sleeping
pills" can lead to cognitive impairment and risk of falls. Thus, it is not surprising that
non-pharmacological treatments for insomnia have been pursued as alternatives to medications,
with some suggesting they should be the "first line of therapy". We propose a randomized
clinical trial to evaluate the relative efficacy and effectiveness of specific components of
cognitive behavioral therapies for insomnia (CBT-I): sleep restriction (SR) and cognitive
therapy (CT) in comparison to combined SR and CT (SR+CT). We hypothesize that because the
proposed mechanisms of action of CT versus SR substantially differ, their combination may
have additive effects. Even though the mechanisms of action of SR and CT may differ, no data
exists to document that the addition of one to the other provides more overall clinical
benefit than either intervention alone. Finally, to better understand "how" and "in whom" SR
and CT work, we plan to formally evaluate selected mediators and moderators of the clinical
effect including physiological measures of anxiety and arousal. Three treatments (SR, CT, and
SR+CT) will be compared in a randomized clinical trial with a parallel groups design.
Efficacy and effectiveness data will be collected prior to the beginning of treatment, after
6 weeks of treatment, and at the end of a 6-month follow-up. These efforts follow the
National Institute of Mental Health Strategic Plan Strategy 3.1 to develop innovative
interventions and designs for intervention studies, in this case, to promote a new
intervention trial that focuses on the mediators and moderators of treatment response.

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