- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02946957
OsteoArthritis and Therapy for Sleep (OATS)
April 1, 2020 updated by: Michael Vitiello, University of Washington
Efficacy of Scalable CBT for Insomnia in Older Adults With Osteoarthritis Pain
Osteoarthritis (OA) pain affects 50 percent of older adults, more than half of whom also experience significant sleep disturbance.
This randomized trial will determine whether a telephone-based cognitive behavioral treatment targeting insomnia in older adults with chronic severe OA-related insomnia and pain results in substantially greater reductions in insomnia severity and in related improvements in pain, fatigue, mood, quality of life and healthcare costs compared to telephone-delivered education (attention control) about insomnia.
The trial will test an intervention that if demonstrated to have long term efficacy is scalable and has the potential for wide-scale deployment in healthcare systems.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Twenty-five percent of older adults experience significant osteoarthritis (OA)-related comorbid sleep disturbance.
Insomnia is associated with substantial negative effects on function, mood, and medical resource utilization.
Cognitive behavioral therapy for insomnia (CBT-I) is evidence based and has been shown to be efficacious in populations with a variety of comorbid conditions including OA-related chronic pain.
However, in-person CBT interventions are unlikely to be widely deployable in healthcare systems.
Telephone delivery has the advantage of giving patients access to personalized, efficacious CBT-I interventions from home, increasing generalizability, and outreach to minority, rural, and other underserved populations.
Older (60+ yrs) primary care patients across Washington State will be screened for severe persistent OA-related insomnia and pain.
Two hundred and seventy patients will be randomized to either CBT-I or an education only attention control (EOC).
Each treatment will consist of six 20-30 minute telephone-based sessions over an eight week period.
Pre-treatment, post-treatment (2 months and 12 month) assessments will include measures of sleep, pain, fatigue, mood, and quality of life.
A cost effectiveness evaluation of the intervention will also be conducted.
The proposed research will determine if telephone CBT-I improves OA insomnia and associated outcomes in a state-wide primary care population of older adults, and inform policy decisions about widespread dissemination of telephone CBT-I in this and related patient populations.
Study Type
Interventional
Enrollment (Actual)
327
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Washington
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Seattle, Washington, United States, 98101
- Kaiser Permanente Washington Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 60+ with one or more health care visits for OA in the prior 3 years
- Score of ≥6 on 4-item ISI at first screening and ≥11 on full ISI at second screening
- Score of ≥9 on two items from the Brief Pain Inventory (BPI) asking about average pain intensity in the past 2 weeks (0-10 scale) and activity interference due to pain (0-10 scale) at first and second screening
Exclusion Criteria:
- Not continuously enrolled at Group Health Cooperative for at least one year
- Prior diagnosis of a primary sleep disorder: sleep apnea with an AHI/RDI score of 15+ or current use of a CPAP machine; periodic leg movement disorder; restless leg syndrome; sleep-wake cycle disturbance; or rapid eye movement behavior disorder
- Diagnosis in the medical record of: rheumatoid arthritis, terminal disease, being considered for major surgery, active chemotherapy or radiation for cancer, or inpatient treatment for congestive heart failure within the previous 6 months
- Diagnosis of dementia, use of acetylcholinesterase inhibitor and/or memantine for cognitive impairment, or cognitive impairment (>6 on the Short Orientation-Memory-Concentration Test)
- Hearing or speech impairment sufficient to preclude participation in a telephone intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive Behavioral Therapy
Cognitive Behavioral Therapy for Insomnia is delivered by trained sleep therapists in six telephone sessions.
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Six telephone sessions that last 20-30 minutes presenting cognitive behavioral therapy for insomnia.
Other Names:
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Active Comparator: Education Control
Education Only Control is delivered by trained sleep therapists in six telephone sessions.
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Six telephone sessions that last 20-30 minutes presenting sleep and osteoarthritis education.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insomnia Severity Index (ISI)
Time Frame: 12 months post baseline
|
A 7-item questionnaire that is a global measure of perceived insomnia severity.
Items use a 5-point scale for total scores of 0-28, with >15 considered moderate severity.
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12 months post baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Insomnia Severity Index (ISI)
Time Frame: 2 months post baseline
|
A 7-item questionnaire that is a global measure of perceived insomnia severity.Items use a 5-point scale for total scores of 0-28, with >15 considered moderate severity.
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2 months post baseline
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Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 2 months post baseline
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Self-rating of overall sleep quality and disturbances using 7 sleep.
components.
PSQI global >5 is highly sensitive and specific for distinguishing good and poor sleepers.
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2 months post baseline
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Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 12 months post baseline
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Self-rating of overall sleep quality and disturbances using 7 sleep components.
PSQI global >5 is highly sensitive and specific for distinguishing good and poor sleepers.
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12 months post baseline
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Brief Pain Inventory-short form (BPI-sf)
Time Frame: 2 months post baseline
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A questionnaire to assess pain intensity and interference with activities.
The BPI-sf rates pain intensity (4 items) and interference (7 items) from 0 to 10 and is validated for use in clinical trials with OA pain patients.
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2 months post baseline
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Brief Pain Inventory-short form (BPI-sf)
Time Frame: 12 months post baseline
|
A questionnaire to assess pain intensity and interference with activities.
The BPI-sf rates pain intensity (4 items) and interference (7 items) from 0 to 10 and is validated for use in clinical trials with OA pain patients.
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12 months post baseline
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Flinders Fatigue Scale (FFS)
Time Frame: 2 months post baseline
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A 7-item self-report questionnaire to measure fatigue level in a variety of situations.
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2 months post baseline
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Flinders Fatigue Scale (FFS)
Time Frame: 12 months post baseline
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A 7-item self-report questionnaire to measure fatigue level in a variety of situations.
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12 months post baseline
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Patient Health Questionnaire (PHQ-8)
Time Frame: 2 months post baseline
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4-point scale rates frequency of occurrence of 8 depressive symptoms.
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2 months post baseline
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Patient Health Questionnaire (PHQ-8)
Time Frame: 12 months post baseline
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4-point scale rates frequency of occurrence of 8 depressive symptoms.
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12 months post baseline
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Sleep Hygiene Index (SHI)
Time Frame: 2 months post baseline
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A 13-item scale that rates how often participants engage in specific sleep hygiene related behaviors, including continued adherence to CBT-I recommendations over time.
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2 months post baseline
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Sleep Hygiene Index (SHI)
Time Frame: 12 months post baseline
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A 13-item scale that rates how often participants engage in specific sleep hygiene related behaviors, including continued adherence to CBT-I recommendations over time.
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12 months post baseline
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EuroQoL 5D (EQ-5D)
Time Frame: 2 months post baseline
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Rates health status on five dimensions and overall health status from 0 to 100.
The most widely used measure in clinical trials assessing general quality of life of OA patients.
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2 months post baseline
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EuroQoL 5D (EQ-5D)
Time Frame: 12 months post baseline
|
Rates health status on five dimensions and overall health status from 0 to 100.
The most widely used measure in clinical trials assessing general quality of life of OA patients.
|
12 months post baseline
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Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame: 2 months post baseline
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A 24-item questionnaire rating pain, stiffness, and physical functioning in everyday activities.
It is the most widely used condition-specific quality of life measure for arthritis cost-effectiveness studies.
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2 months post baseline
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Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time Frame: 12 months post baseline
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A 24-item questionnaire rating pain, stiffness, and physical functioning in everyday activities.
It is the most widely used condition-specific quality of life measure for arthritis cost-effectiveness studies.
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12 months post baseline
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Use of sleep and pain medications
Time Frame: Baseline through 24 months
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NSAID, analgesic, sedative, and anti-depressant medication use.
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Baseline through 24 months
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Outpatient visits
Time Frame: Baseline through 24 months
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The number of visits for OA, for sleep problems, and for visits irrespective of associated diagnosis.
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Baseline through 24 months
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Health care costs
Time Frame: Baseline through 24 months
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The Group Health cost database will be used to estimate costs (from study entry to 24 months post enrollment) of ambulatory healthcare for all conditions, arthritis and sleep problems, and inpatient care.
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Baseline through 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael V Vitiello, PhD, University of Washington
- Principal Investigator: Michael Von Korff, ScD, University of Washington
- Principal Investigator: Kai Yeung, PhD, Kaiser Permanente
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Thakral M, Von Korff M, McCurry SM, Morin CM, Vitiello MV. ISI-3: evaluation of a brief screening tool for insomnia. Sleep Med. 2021 Jun;82:104-109. doi: 10.1016/j.sleep.2020.08.027. Epub 2020 Aug 27.
- Vitiello MV, Zhu W, Von Korff M, Wellman R, Morin CM, Yeung K, McCurry SM. Long-term improvements in sleep, pain, depression, and fatigue in older adults with comorbid osteoarthritis pain and insomnia. Sleep. 2022 Feb 14;45(2):zsab231. doi: 10.1093/sleep/zsab231.
- McCurry SM, Zhu W, Von Korff M, Wellman R, Morin CM, Thakral M, Yeung K, Vitiello MV. Effect of Telephone Cognitive Behavioral Therapy for Insomnia in Older Adults With Osteoarthritis Pain: A Randomized Clinical Trial. JAMA Intern Med. 2021 Apr 1;181(4):530-538. doi: 10.1001/jamainternmed.2020.9049.
- McCurry SM, Von Korff M, Morin CM, Cunningham A, Pike KC, Thakral M, Wellman R, Yeung K, Zhu W, Vitiello MV. Telephone interventions for co-morbid insomnia and osteoarthritis pain: The OsteoArthritis and Therapy for Sleep (OATS) randomized trial design. Contemp Clin Trials. 2019 Dec;87:105851. doi: 10.1016/j.cct.2019.105851. Epub 2019 Oct 13.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Actual)
December 1, 2019
Study Completion (Anticipated)
November 1, 2020
Study Registration Dates
First Submitted
October 19, 2016
First Submitted That Met QC Criteria
October 25, 2016
First Posted (Estimate)
October 27, 2016
Study Record Updates
Last Update Posted (Actual)
April 3, 2020
Last Update Submitted That Met QC Criteria
April 1, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 52176
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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