NCT02946957

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
327

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

April 3, 2020

Status Verified

March 1, 2020

Enrollment Period

3.2 years

First QC Date

October 19, 2016

Last Update Submit

April 1, 2020

Conditions

Insomnia Related to Osteoarthritis Pain

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (18)

  • 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

  • +13 more secondary outcomes

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia is delivered by trained sleep therapists in six telephone sessions.

Behavioral: Cognitive Behavior Therapy for Insomnia

Education Control

ACTIVE COMPARATOR

Education Only Control is delivered by trained sleep therapists in six telephone sessions.

Behavioral: Education Only Control

Interventions

Cognitive Behavior Therapy for InsomniaBEHAVIORAL

Six telephone sessions that last 20-30 minutes presenting cognitive behavioral therapy for insomnia.

Also known as: CBT-I
Cognitive Behavioral Therapy
Education Only ControlBEHAVIORAL

Six telephone sessions that last 20-30 minutes presenting sleep and osteoarthritis education.

Also known as: EOC
Education Control

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Washington Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (4)

  • 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.

    PMID: 34516646DERIVED

  • 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.

    PMID: 33910159DERIVED

  • 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.

    PMID: 33616613DERIVED

  • 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.

    PMID: 31614214DERIVED

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Michael V Vitiello, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Susan M McCurry, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Michael Von Korff, ScD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Kai Yeung, PhD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

October 19, 2016

First Posted

October 27, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2019

Study Completion

November 1, 2020

Last Updated

April 3, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)