Treatments for Insomnia: Mediators, Moderators and Quality of Life

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).

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy; Behavioral: Sleep Restriction; Behavioral: Combined Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • VA Palo Alto Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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.	Behavioral: 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.
Experimental: Combined Therapy Treatment for Insomnia; Combined Therapy involves combining Sleep Restriction and Cognitive Therapy so that the two therapies reinforce each other.	Behavioral: Combined Therapy; Sleep Restriction and Cognitive Therapy will be combined so that the two therapies reinforce each other.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index	Subject's subjective evaluation of their sleep.	Screening, End of 6-week treatment, 6-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Arousal	Score on Penn State Worry Questionnaire, and Dysfunctional Beliefs and Attitudes about Sleep Scale. Both measures have been found to be successful in measuring mediators and moderators of treatment response.	Screening, end of 6-week treatment, 6-month followup
Chronic Stress	We are using two of the most widely utilized psychometric indices of past, present and chronic stress exposure: 1) the Trauma History Questionnaire, and 2) the Life Stressor Checklist revised, a clinical interview for lifetime exposure to stressful life events.	Screening, end of 6-week treatment, 6-month followup

Collaborators and Investigators

• Sponsor: Palo Alto Veterans Institute for Research
• Collaborators: National Institute of Mental Health (NIMH); US Department of Veterans Affairs
• Investigators: Principal Investigator: Jerome A. Yesavage, MD, VA/Stanford

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): August 23, 2019
• Study Completion (Actual): August 23, 2019

Study Registration Dates

• First Submitted: February 4, 2014
• First Submitted That Met QC Criteria: April 15, 2014
• First Posted (Estimate): April 17, 2014

Study Record Updates

• Last Update Posted (Actual): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: insomnia; Older adults; Cognitive Therapy; Behavioral Therapy; CBT-I (cognitive behavioral therapy-insomnia); SRT (sleep restriction therapy)
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 27264; 1R01MH101468-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED