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Treatments for Insomnia: Mediators, Moderators and Quality of Life

Primary Purpose

Insomnia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sleep Restriction

Cognitive Behavioral Therapy

Combined Therapy

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Older adults, insomnia, CBT-I (cognitive behavioral therapy-insomnia), Behavioral Therapy, SRT (sleep restriction therapy), Cognitive Therapy

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

VA Palo Alto Health Care System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Cognitive Behavioral Therapy

Sleep Restriction

Combined Therapy Treatment for Insomnia

Arm Description

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

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

Outcomes

Primary Outcome Measures

Insomnia Severity Index

Subject's subjective evaluation of their sleep.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT02117388

First Posted

February 4, 2014

Last Updated

September 18, 2019

Sponsor

Palo Alto Veterans Institute for Research

Collaborators

National Institute of Mental Health (NIMH), US Department of Veterans Affairs

1. Study Identification

Unique Protocol Identification Number

NCT02117388

Brief Title

Treatments for Insomnia: Mediators, Moderators and Quality of Life

Official Title

Treatments for Insomnia: Mediators, Moderators and Quality of Life

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

September 2013 (Actual)

Primary Completion Date

August 23, 2019 (Actual)

Study Completion Date

August 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Palo Alto Veterans Institute for Research

Collaborators

National Institute of Mental Health (NIMH), US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia

Keywords

Older adults, insomnia, CBT-I (cognitive behavioral therapy-insomnia), Behavioral Therapy, SRT (sleep restriction therapy), Cognitive Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

128 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitive Behavioral Therapy

Arm Type

Experimental

Arm Description

Arm Title

Sleep Restriction

Arm Type

Experimental

Arm Description

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

Arm Title

Combined Therapy Treatment for Insomnia

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Sleep Restriction

Intervention Description

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

Intervention Name(s)

Cognitive Behavioral Therapy

Intervention Description

Intervention Type

Behavioral

Intervention Name(s)

Combined Therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Insomnia Severity Index

Description

Subject's subjective evaluation of their sleep.

Time Frame

Screening, End of 6-week treatment, 6-month follow-up

Secondary Outcome Measure Information:

Title

Cognitive Arousal

Description

Time Frame

Screening, end of 6-week treatment, 6-month followup

Title

Chronic Stress

Description

Time Frame

Screening, end of 6-week treatment, 6-month followup

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jerome A. Yesavage, MD

Organizational Affiliation

VA/Stanford

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Palo Alto Health Care System

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Treatments for Insomnia: Mediators, Moderators and Quality of Life

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