NCT02946957|UnknownDMC
OsteoArthritis and Therapy for Sleep
OATS
Efficacy of Scalable CBT for Insomnia in Older Adults With Osteoarthritis Pain
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OATS
Efficacy of Scalable CBT for Insomnia in Older Adults With Osteoarthritis Pain
Sponsor study identifier
interventional
327
1 country
1
Study Start
October 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2019
Actual (reported)Study Completion
November 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2016
Date type not reportedThis date has not been verified as actual or estimated.
October 19, 2016
Actual (reported)October 27, 2016
Actual (reported)December 2019
Actual (reported)November 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Insomnia Severity Index (ISI)
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.
12 months post baseline
Insomnia Severity Index (ISI)
2 months post baseline
Pittsburgh Sleep Quality Index (PSQI)
2 months post baseline
Pittsburgh Sleep Quality Index (PSQI)
12 months post baseline
Brief Pain Inventory-short form (BPI-sf)
2 months post baseline
Brief Pain Inventory-short form (BPI-sf)
12 months post baseline
Cognitive Behavioral Therapy for Insomnia is delivered by trained sleep therapists in six telephone sessions.
Education Only Control is delivered by trained sleep therapists in six telephone sessions.
Six telephone sessions that last 20-30 minutes presenting cognitive behavioral therapy for insomnia.
Six telephone sessions that last 20-30 minutes presenting sleep and osteoarthritis education.
Kaiser Permanente Washington Research Institute
Seattle, Washington, 98101, United States
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.
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.
Michael V Vitiello, PhD
University of Washington
Susan M McCurry, PhD
University of Washington
Michael Von Korff, ScD
University of Washington
Kai Yeung, PhD
Kaiser Permanente
327 participants (actual enrollment reported by the registry).
First Submitted
October 19, 2016
First Posted
October 27, 2016
Study Start
October 2016
Date type not reportedThis date has not been verified as actual or estimated.
A Conversational Agent (Cecebot) to Improve Insomnia in Stage I-III Breast Cancer Survivors
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Primary Completion
December 2019
Actual (reported)Study Completion
November 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 3, 2020
Record last verified: 2020-03
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