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Treatments for Insomnia: Mediators, Moderators and Quality of Life

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ClinicalTrials.gov Identifier: NCT02117388
Recruitment Status : Completed
First Posted : April 17, 2014
Last Update Posted : September 20, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
US Department of Veterans Affairs
Information provided by (Responsible Party):
Jerome Yesavage, Palo Alto Veterans Institute for Research

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).

Condition or disease Intervention/treatment Phase
Insomnia Behavioral: Sleep Restriction Behavioral: Cognitive Behavioral Therapy Behavioral: Combined Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatments for Insomnia: Mediators, Moderators and Quality of Life
Actual Study Start Date : September 2013
Actual Primary Completion Date : August 23, 2019
Actual Study Completion Date : August 23, 2019

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.




Primary Outcome Measures :
  1. Insomnia Severity Index [ Time Frame: Screening, End of 6-week treatment, 6-month follow-up ]
    Subject's subjective evaluation of their sleep.


Secondary Outcome Measures :
  1. Cognitive Arousal [ Time Frame: Screening, end of 6-week treatment, 6-month followup ]

    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.


  2. Chronic Stress [ Time Frame: Screening, end of 6-week treatment, 6-month followup ]
    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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117388


Locations
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United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Palo Alto Veterans Institute for Research
National Institute of Mental Health (NIMH)
US Department of Veterans Affairs
Investigators
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Principal Investigator: Jerome A. Yesavage, MD VA/Stanford
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Responsible Party: Jerome Yesavage, Principal Investigator, Palo Alto Veterans Institute for Research
ClinicalTrials.gov Identifier: NCT02117388    
Other Study ID Numbers: 27264
1R01MH101468-01 ( U.S. NIH Grant/Contract )
First Posted: April 17, 2014    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jerome Yesavage, Palo Alto Veterans Institute for Research:
Older adults
insomnia
CBT-I (cognitive behavioral therapy-insomnia)
Behavioral Therapy
SRT (sleep restriction therapy)
Cognitive Therapy
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders