Clinical trial NCT02117388: Treatments for Insomnia: Mediators, Moderators and Quality of Life
Official title: Treatments for Insomnia: Mediators, Moderators and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Older adults
insomnia
CBT-I (cognitive behavioral therapy-insomnia)
Behavioral Therapy
SRT (sleep restriction therapy)
Cognitive Therapy
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: US Department of Veterans Affairs
First posted: 2014-04-17
Enrollment: 128
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: Screening, End of 6-week treatment, 6-month follow-up
Secondary outcomes:
measure: Cognitive Arousal
timeFrame: Screening, end of 6-week treatment, 6-month followup
measure: Chronic Stress
timeFrame: Screening, end of 6-week treatment, 6-month followup
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
affiliation: VA/Stanford
name: Jerome A. Yesavage, MD
role: PRINCIPAL_INVESTIGATOR
References: