- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02946957
OsteoArthritis and Therapy for Sleep (OATS)
2020년 4월 1일 업데이트: 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.
연구 개요
상태
알려지지 않은
상세 설명
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.
연구 유형
중재적
등록 (실제)
327
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Washington
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Seattle, Washington, 미국, 98101
- Kaiser Permanente Washington Research Institute
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
60년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
다른 이름들:
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활성 비교기: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Insomnia Severity Index (ISI)
기간: 12 months post baseline
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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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Insomnia Severity Index (ISI)
기간: 2 months post baseline
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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)
기간: 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)
기간: 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)
기간: 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)
기간: 12 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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12 months post baseline
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Flinders Fatigue Scale (FFS)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 12 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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12 months post baseline
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Western Ontario and McMaster Universities Arthritis Index (WOMAC)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Michael V Vitiello, PhD, University of Washington
- 수석 연구원: Michael Von Korff, ScD, University of Washington
- 수석 연구원: Kai Yeung, PhD, Kaiser Permanente
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2016년 10월 1일
기본 완료 (실제)
2019년 12월 1일
연구 완료 (예상)
2020년 11월 1일
연구 등록 날짜
최초 제출
2016년 10월 19일
QC 기준을 충족하는 최초 제출
2016년 10월 25일
처음 게시됨 (추정)
2016년 10월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 4월 3일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 4월 1일
마지막으로 확인됨
2020년 3월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Cognitive Behavior Therapy for Insomnia에 대한 임상 시험
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Masaryk UniversityMasaryk Memorial Cancer Institute모병
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Masaryk UniversityMasaryk Memorial Cancer Institute모병