Exercise + Insomnia Treatment for Knee Osteoarthritis

Recruiting in Palo Alto (17 mi)

Overseen by Daniel Whibley, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Michigan

Disqualifiers: Rheumatoid arthritis, Active malignancy, Neurological, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{5 6 7 8 9}

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. ^{1 5 10 11 12}

Research Team

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.

Trial 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 (Behavioral Intervention)

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

Group I: Personalized exercise program Experimental Treatment 1 Intervention

Group II: Move and Snooze program Experimental Treatment 2 Interventions

This includes the personalized exercise program plus Cognitive Behavioral Therapy for Insomnia (CBT-I).

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Michigan Ann Arbor, MI

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1891

Patients Recruited

6,458,000+

National Institute on Aging (NIA)

Collaborator

Trials

1841

Patients Recruited

28,150,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes. Wagley, JN., Rybarczyk, B., Nay, WT., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioural therapy for primary insomnia: effectiveness in a clinical setting]. Van Houdenhove, L., Buyse, B., Gabriels, L., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-Guided Internet-Delivered Cognitive Behavioral Therapy for Insomnia in General Practice: Results from a Pragmatic Randomized Clinical Trial. Van der Zweerde, T., Lancee, J., Slottje, P., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. Wu, JQ., Appleman, ER., Salazar, RD., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise as an Adjunct Treatment to Cognitive Behavior Therapy for Insomnia. Passos, GS., Youngstedt, SD., Santana, MG.[2023]

Cognitive Behavioral Therapy for Insomnia (CBT-I) is an effective, evidence-based treatment for insomnia that is increasingly recognized as a standalone health issue, especially when it coexists with psychiatric disorders.

Recent studies indicate that CBT-I not only improves sleep quality but also positively impacts psychiatric symptoms in individuals with conditions like anxiety, depression, and PTSD, highlighting its dual benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioural Therapy for Insomnia in Psychiatric Disorders. Jansson-Fröjmark, M., Norell-Clarke, A.[2020]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. Trauer, JM., Qian, MY., Doyle, JS., et al.[2022]

Cognitive behavior therapy for insomnia (CBT-I) shows moderate to large treatment effects (Cohen's d range of 0.35-2.2) for patients with insomnia related to various medical and psychiatric conditions, indicating its efficacy beyond primary insomnia.

Improving sleep through CBT-I may also lead to better outcomes in managing comorbid medical and psychological conditions, highlighting the need for further research on adapting CBT-I for specific disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. Smith, MT., Huang, MI., Manber, R.[2022]

Cognitive-behavioral therapy for insomnia (CBT-I) significantly improved sleep quality in patients with knee osteoarthritis (OA) compared to an active placebo, leading to greater reductions in wake after sleep onset.

Improvements in sleep quality predicted reductions in clinical pain, indicating that CBT-I may enhance pain management in knee OA, although it did not affect pain modulation mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for insomnia in knee osteoarthritis: a randomized, double-blind, active placebo-controlled clinical trial. Smith, MT., Finan, PH., Buenaver, LF., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Skarpsno, ES., Simpson, MR., Seim, A., et al.[2023]

Cognitive-behavioral therapy (CBT) for insomnia significantly improved sleep quality in older adults with chronic conditions, outperforming a placebo stress management and wellness training in 8 out of 10 self-report measures.

The effectiveness of CBT was consistent regardless of the type of chronic disease, suggesting that psychological factors play a crucial role in insomnia, even when it is linked to medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A placebo-controlled test of cognitive-behavioral therapy for comorbid insomnia in older adults. Rybarczyk, B., Stepanski, E., Fogg, L., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

A Preliminary Examination of the Effects and Mechanisms of Cognitive Behavioral Therapy for Insomnia on Systemic Inflammation Among Patients with Knee Osteoarthritis. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of abbreviated CBT for insomnia in psychiatric outpatients: sleep and depression outcomes. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

[Cognitive-behavioural therapy for primary insomnia: effectiveness in a clinical setting]. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Nurse-Guided Internet-Delivered Cognitive Behavioral Therapy for Insomnia in General Practice: Results from a Pragmatic Randomized Clinical Trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia Comorbid With Psychiatric and Medical Conditions: A Meta-analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Exercise as an Adjunct Treatment to Cognitive Behavior Therapy for Insomnia. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive Behavioural Therapy for Insomnia in Psychiatric Disorders. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Chronic Insomnia: A Systematic Review and Meta-analysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for chronic insomnia occurring within the context of medical and psychiatric disorders. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for insomnia in knee osteoarthritis: a randomized, double-blind, active placebo-controlled clinical trial. [2022]

11. New Zealand pubmed.ncbi.nlm.nih.gov

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 States pubmed.ncbi.nlm.nih.gov

A placebo-controlled test of cognitive-behavioral therapy for comorbid insomnia in older adults. [2022]