Treatments for Insomnia: Mediators, Moderators and Quality of Life

NCT ID: NCT02117388

Last Updated: 2019-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2019-08-23

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.

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive Behavioral Therapy

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.

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

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

Sleep Restriction therapy will limit the time participants spend in bed in order to make sure they are sleepy enough to fall asleep quickly.

Group Type: EXPERIMENTAL

Sleep Restriction

Intervention Type: BEHAVIORAL

Sleep Restriction therapy will limit the time spent in bed in order to make sure participants are sleepy enough to fall asleep quickly.

Combined Therapy Treatment for Insomnia

Combined Therapy involves combining Sleep Restriction and Cognitive Therapy so that the two therapies reinforce each other.

Group Type: EXPERIMENTAL

Combined Therapy

Intervention Type: BEHAVIORAL

Sleep Restriction and Cognitive Therapy will be combined so that the two therapies reinforce each other.

Interventions

Sleep Restriction

Sleep Restriction therapy will limit the time spent in bed in order to make sure participants are sleepy enough to fall asleep quickly.

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy

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.

Intervention Type: BEHAVIORAL

Combined Therapy

Sleep Restriction and Cognitive Therapy will be combined so that the two therapies reinforce each other.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

Palo Alto Veterans Institute for Research

OTHER

Sponsor Role: lead

Responsible Party

Jerome Yesavage

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jerome A. Yesavage, MD

Role: PRINCIPAL_INVESTIGATOR

VA/Stanford

Locations

VA Palo Alto Health Care System

Palo Alto, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40476601 (View on PubMed)

Other Identifiers

1R01MH101468-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

27264

Identifier Type: -

Identifier Source: org_study_id