Insomnia Related to Osteoarthritis PainOATSNCT02946957
OsteoArthritis and Therapy for Sleep
A study testing Cognitive Behavior Therapy for Insomnia in people with Insomnia Related to Osteoarthritis Pain, run by University of Washington at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Insomnia Related to Osteoarthritis Pain
- What is being tested?
- Cognitive Behavior Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Washington Research Institute
Seattle, Washington, 98101
About this study
Official title: 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.
Read the 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.
- Conditions
- Insomnia Related to Osteoarthritis Pain
- Being tested
- Cognitive Behavior Therapy for Insomnia, Education Only Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior Therapy for InsomniaBehavioural
Also called CBT-I
Six telephone sessions that last 20-30 minutes presenting cognitive behavioral therapy for insomnia.
Education Only ControlBehavioural
Also called EOC
Six telephone sessions that last 20-30 minutes presenting sleep and osteoarthritis education.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Cognitive Behavioral Therapy for Insomnia is delivered by trained sleep therapists in six telephone sessions. Receives: Behavioral: Cognitive Behavior Therapy for Insomnia |
| Education Control | Active comparator | Education Only Control is delivered by trained sleep therapists in six telephone sessions. Receives: Behavioral: Education Only Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months post baseline
Secondary outcomes (18)
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.
Measured: 2 months post baseline
Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: 2 months post baseline
Pittsburgh Sleep Quality Index (PSQI)
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.
Measured: 12 months post baseline
Brief Pain Inventory-short form (BPI-sf)
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.
Measured: 2 months post baseline
Brief Pain Inventory-short form (BPI-sf)
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.
Measured: 12 months post baseline
Flinders Fatigue Scale (FFS)
A 7-item self-report questionnaire to measure fatigue level in a variety of situations.
Measured: 2 months post baseline
Flinders Fatigue Scale (FFS)
A 7-item self-report questionnaire to measure fatigue level in a variety of situations.
Measured: 12 months post baseline
Patient Health Questionnaire (PHQ-8)
4-point scale rates frequency of occurrence of 8 depressive symptoms.
Measured: 2 months post baseline
Patient Health Questionnaire (PHQ-8)
4-point scale rates frequency of occurrence of 8 depressive symptoms.
Measured: 12 months post baseline
Sleep Hygiene Index (SHI)
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.
Measured: 2 months post baseline
Sleep Hygiene Index (SHI)
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.
Measured: 12 months post baseline
EuroQoL 5D (EQ-5D)
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.
Measured: 2 months post baseline
EuroQoL 5D (EQ-5D)
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.
Measured: 12 months post baseline
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
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.
Measured: 2 months post baseline
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
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.
Measured: 12 months post baseline
Use of sleep and pain medications
NSAID, analgesic, sedative, and anti-depressant medication use.
Measured: Baseline through 24 months
Outpatient visits
The number of visits for OA, for sleep problems, and for visits irrespective of associated diagnosis.
Measured: Baseline through 24 months
Health care costs
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.
Measured: Baseline through 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2019
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Insomnia Related to Osteoarthritis PainStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente
- Responsible party
- Principal investigator, Michael Vitiello, University of Washington
- Investigators
- Michael V Vitiello, PhD, Principal investigator, University of WashingtonSusan M McCurry, PhD, Principal investigator, University of WashingtonMichael Von Korff, ScD, Principal investigator, University of WashingtonKai Yeung, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946957
- Sponsor's protocol ID
- 52176
- Acronym
- OATS
- Status last verified
- Mar 2020
- First submitted
- 19 Oct 2016
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34516646Thakral 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.
PubMed 33910159McCurry 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.
PubMed 33616613McCurry 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.
PubMed 31614214
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Scalable CBT for Insomnia in Older Adults With Osteoarthritis Pain
- ClinicalTrials.gov ID
- NCT02946957
- Acronym / sponsor ID
- OATS / 52176
- Conditions
- Insomnia Related to Osteoarthritis Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 327 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Kaiser Permanente
- Study start
- Oct 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Nov 2020 (estimated)
- First posted
- 27 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavior Therapy for InsomniaCognitive Behavioral Therapy for Insomnia is delivered by trained sleep therapists in six telephone sessions. |
| Education Control | Active comparator | Behavioral: Education Only ControlEducation Only Control is delivered by trained sleep therapists in six telephone sessions. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavior Therapy for InsomniaAlso: CBT-ISix telephone sessions that last 20-30 minutes presenting cognitive behavioral therapy for insomnia. | Behavioural | Cognitive Behavioral Therapy |
| Education Only ControlAlso: EOCSix telephone sessions that last 20-30 minutes presenting sleep and osteoarthritis education. | Behavioural | Education Control |
Primary outcome
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.
18 secondary outcomes
Insomnia Severity Index (ISI)
Time frame: 2 months post baseline
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 2 months post baseline
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 12 months post baseline
Brief Pain Inventory-short form (BPI-sf)
Time frame: 2 months post baseline
Brief Pain Inventory-short form (BPI-sf)
Time frame: 12 months post baseline
Flinders Fatigue Scale (FFS)
Time frame: 2 months post baseline
Flinders Fatigue Scale (FFS)
Time frame: 12 months post baseline
Patient Health Questionnaire (PHQ-8)
Time frame: 2 months post baseline
Patient Health Questionnaire (PHQ-8)
Time frame: 12 months post baseline
Sleep Hygiene Index (SHI)
Time frame: 2 months post baseline
Sleep Hygiene Index (SHI)
Time frame: 12 months post baseline
EuroQoL 5D (EQ-5D)
Time frame: 2 months post baseline
EuroQoL 5D (EQ-5D)
Time frame: 12 months post baseline
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 2 months post baseline
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 12 months post baseline
Use of sleep and pain medications
Time frame: Baseline through 24 months
Outpatient visits
Time frame: Baseline through 24 months
Health care costs
Time frame: Baseline through 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Derived from this study: PubMed 34516646Vitiello 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.
- Derived from this study: PubMed 33910159Thakral 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.
- Derived from this study: PubMed 33616613McCurry 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.
- Derived from this study: PubMed 31614214McCurry 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael V Vitiello, PhD principal investigator
University of Washington
Susan M McCurry, PhD principal investigator
University of Washington
Michael Von Korff, ScD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Therapy for Insomnia in people with Insomnia Related to Osteoarthritis Pain, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: 12 months post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02946957, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.