Treatments for Insomnia: Mediators, Moderators and Quality of Life
2 other identifiers
interventional
128
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 4, 2014
CompletedFirst Posted
Study publicly available on registry
April 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 23, 2019
CompletedSeptember 20, 2019
September 1, 2019
6 years
February 4, 2014
September 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Insomnia Severity Index
Subject's subjective evaluation of their sleep.
Screening, End of 6-week treatment, 6-month follow-up
Secondary Outcomes (2)
Cognitive Arousal
Screening, end of 6-week treatment, 6-month followup
Chronic Stress
Screening, end of 6-week treatment, 6-month followup
Study Arms (3)
Cognitive Behavioral Therapy
EXPERIMENTALCognitive Behavioral Therapy is designed to identify incorrect ideas about sleep, challenge their validity, and replace them with correct information. This therapy tries to reduce worry, anxiety, and fear that one won't sleep by providing accurate information about sleep.
Sleep Restriction
EXPERIMENTALSleep Restriction therapy will limit the time participants spend in bed in order to make sure they are sleepy enough to fall asleep quickly.
Combined Therapy Treatment for Insomnia
EXPERIMENTALCombined Therapy involves combining Sleep Restriction and Cognitive Therapy so that the two therapies reinforce each other.
Interventions
Sleep Restriction therapy will limit the time spent in bed in order to make sure participants are sleepy enough to fall asleep quickly.
Cognitive Behavioral Therapy is designed to identify incorrect ideas about sleep, challenge their validity, and replace them with correct information. This therapy tries to reduce worry, anxiety, and fear that one won't sleep by providing accurate information about sleep.
Sleep Restriction and Cognitive Therapy will be combined so that the two therapies reinforce each other.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Palo Alto Health Care System
Palo Alto, California, 94304, United States
Related Publications (1)
O'Hora KP, Morehouse AB, Freidman L, Posner D, Ahmadi M, Hernandez B, Burda KF, Kushida C, Zeitzer JM, Lazzeroni LC, Manber R, Yesavage J, Goldstein-Piekarski AN. Comparative effectiveness and predictors of cognitive behavioral therapy for insomnia and its components in older adults: main outcomes of a randomized dismantling trial. J Clin Sleep Med. 2025 Oct 1;21(10):1679-1695. doi: 10.5664/jcsm.11756.
PMID: 40476601DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jerome A. Yesavage, MD
VA/Stanford
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 4, 2014
First Posted
April 17, 2014
Study Start
September 1, 2013
Primary Completion
August 23, 2019
Study Completion
August 23, 2019
Last Updated
September 20, 2019
Record last verified: 2019-09