288 Participants Needed

Exercise + Insomnia Treatment for Knee Osteoarthritis

JT
KP
DW
Overseen ByDaniel Whibley, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Michigan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

You won't have to stop taking your current medications, but you must not change your pain or sleep medications during the study.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Insomnia (CBT-I) for knee osteoarthritis?

Research suggests that CBT-I can help reduce systemic inflammation, which is important in knee osteoarthritis, by improving sleep quality. Additionally, CBT-I is effective in treating insomnia in people with other medical and psychiatric conditions, which may indirectly benefit those with knee osteoarthritis.12345

Is Cognitive Behavioral Therapy for Insomnia (CBT-I) safe for humans?

Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally considered safe for humans, as it is a non-drug treatment that avoids the risks of side effects associated with medications. It is widely recommended as a first-line treatment for chronic insomnia and has been studied in various conditions, showing positive effects without significant safety concerns.56789

How does the treatment of exercise combined with insomnia therapy differ for knee osteoarthritis?

This treatment is unique because it combines exercise with cognitive behavioral therapy for insomnia (CBT-I), which not only addresses sleep issues but also aims to reduce inflammation and pain associated with knee osteoarthritis. By improving sleep, it may help lower levels of interleukin-6 (IL-6), a marker of inflammation, potentially leading to better pain management and overall joint health.15101112

What is the purpose of this trial?

This research will compare the effectiveness of a remotely delivered personalized exercise coaching plus an evidence-based sleep improvement intervention to remotely delivered personalized exercise coaching alone for knee osteoarthritis pain.The study team hypothesize that the combined intervention will result in greater improvements in patient-reported pain intensity, recorded with real-time data capture, than remotely delivered exercise coaching alone.

Research Team

DW

Daniel Whibley, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for older adults with knee osteoarthritis who also suffer from insomnia. Participants should have a confirmed diagnosis of knee osteoarthritis, moderate to severe persistent pain, and symptoms of insomnia. They must not have changed any pain or sleep medication in the last three months and agree not to change these during the study.

Inclusion Criteria

I have ongoing moderate to severe knee pain from arthritis.
I have been diagnosed with knee osteoarthritis by a doctor.
I can read and understand web surveys on my own.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a remotely delivered personalized exercise coaching plus an evidence-based sleep improvement intervention or exercise coaching alone

8 weeks
Remote sessions

Follow-up

Participants are monitored for changes in pain intensity and other outcomes post-intervention

8 weeks

Treatment Details

Interventions

  • Cognitive behavioral therapy for Insomnia
Trial Overview The study tests if adding cognitive behavioral therapy for insomnia to personalized exercise coaching can better improve pain outcomes than exercise alone in those with knee osteoarthritis. The effectiveness will be measured by patient-reported pain intensity.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Personalized exercise programExperimental Treatment1 Intervention
Group II: Move and Snooze programExperimental Treatment2 Interventions
This includes the personalized exercise program plus Cognitive Behavioral Therapy for Insomnia (CBT-I).

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Findings from Research

Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly improved sleep maintenance disturbance in individuals with knee osteoarthritis and insomnia, but did not lead to a significant reduction in interleukin-6 (IL-6) levels, a marker of systemic inflammation.
While CBT-I showed benefits for sleep quality, it did not provide convincing evidence that these improvements translate into reduced systemic inflammation, indicating that CBT-I alone may not be sufficient for addressing inflammation in this patient group.
A Preliminary Examination of the Effects and Mechanisms of Cognitive Behavioral Therapy for Insomnia on Systemic Inflammation Among Patients with Knee Osteoarthritis.Mun, CJ., Speed, TJ., Finan, PH., et al.[2023]
Cognitive-behavioral therapy for insomnia (CBT-I) showed positive effects on sleep quality and depressive symptoms in a study of 30 psychiatric outpatients, with 38% achieving normal sleep after treatment.
While CBT-I led to significant improvements within the treatment group over 4 and 8 weeks, there were no significant differences when compared to the control group, suggesting that while beneficial, the effects may not be strong enough to outperform standard care alone.
Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes.Wagley, JN., Rybarczyk, B., Nay, WT., et al.[2022]
Cognitive Behavioral Therapy for Insomnia (CBT-I) significantly improved sleep quality, sleep onset, and sleep efficiency in 76 patients with primary insomnia over a 6-week group course in a clinical setting.
CBT-I also led to reductions in medication use and improvements in patients' overall health and cognitive functioning, highlighting its effectiveness beyond just sleep improvement.
[Cognitive-behavioural therapy for primary insomnia: effectiveness in a clinical setting].Van Houdenhove, L., Buyse, B., Gabriels, L., et al.[2018]

References

A Preliminary Examination of the Effects and Mechanisms of Cognitive Behavioral Therapy for Insomnia on Systemic Inflammation Among Patients with Knee Osteoarthritis. [2023]
Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes. [2022]
[Cognitive-behavioural therapy for primary insomnia: effectiveness in a clinical setting]. [2018]
Nurse-Guided Internet-Delivered Cognitive Behavioral Therapy for Insomnia in General Practice: Results from a Pragmatic Randomized Clinical Trial. [2021]
Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. [2022]
Exercise as an Adjunct Treatment to Cognitive Behavior Therapy for Insomnia. [2023]
Cognitive Behavioural Therapy for Insomnia in Psychiatric Disorders. [2020]
Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. [2022]
Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Cognitive-behavioral therapy for insomnia in knee osteoarthritis: a randomized, double-blind, active placebo-controlled clinical trial. [2022]
App-Delivered Cognitive-Behavioral Therapy for Insomnia Among Patients with Comorbid Musculoskeletal Complaints and Insomnia Referred to 4-Week Inpatient Multimodal Rehabilitation: Protocol for a Randomized Clinical Trial. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
A placebo-controlled test of cognitive-behavioral therapy for comorbid insomnia in older adults. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity