Clinical trial NCT02946957: OsteoArthritis and Therapy for Sleep
Official title: Efficacy of Scalable CBT for Insomnia in Older Adults With Osteoarthritis Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia Related to Osteoarthritis Pain
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
First posted: 2016-10-27
Enrollment: 327
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: 12 months post baseline
Secondary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: 2 months post baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 2 months post baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 12 months post baseline
measure: Brief Pain Inventory-short form (BPI-sf)
timeFrame: 2 months post baseline
measure: Brief Pain Inventory-short form (BPI-sf)
timeFrame: 12 months post baseline
measure: Flinders Fatigue Scale (FFS)
timeFrame: 2 months post baseline
measure: Flinders Fatigue Scale (FFS)
timeFrame: 12 months post baseline
measure: Patient Health Questionnaire (PHQ-8)
timeFrame: 2 months post baseline
measure: Patient Health Questionnaire (PHQ-8)
timeFrame: 12 months post baseline
measure: Sleep Hygiene Index (SHI)
timeFrame: 2 months post baseline
measure: Sleep Hygiene Index (SHI)
timeFrame: 12 months post baseline
measure: EuroQoL 5D (EQ-5D)
timeFrame: 2 months post baseline
measure: EuroQoL 5D (EQ-5D)
timeFrame: 12 months post baseline
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: 2 months post baseline
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: 12 months post baseline
measure: Use of sleep and pain medications
timeFrame: Baseline through 24 months
measure: Outpatient visits
timeFrame: Baseline through 24 months
measure: Health care costs
timeFrame: Baseline through 24 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente Washington Research Institute
state: Washington
Study officials:
affiliation: University of Washington
name: Michael V Vitiello, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Susan M McCurry, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington
name: Michael Von Korff, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Kai Yeung, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.