Exercise + Insomnia Treatment for Knee Osteoarthritis

Overseen By Daniel Whibley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Rheumatoid arthritis, Active malignancy, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

288 Participants Needed

What You Need to Know Before You Apply

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.

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. ^{1 2 3 4 5}

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. ^{3 6 7 8 9}

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. ^{3 6 10 11 12}

Who Is on the Research Team?

Daniel Whibley, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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).

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+

Published Research Related to This Trial

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.

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]

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.

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]

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.

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]

Nurse-guided Internet-delivered cognitive behavioral therapy for insomnia (I-CBT-I) significantly reduced insomnia severity in 134 patients, with a large effect size (Cohen's d = 1.66) observed at 8 weeks, indicating its effectiveness as a treatment option.

The benefits of I-CBT-I persisted at 26 weeks, with continued significant improvements in insomnia severity and sleep quality, while no adverse events were reported, suggesting it is a safe intervention for patients in general practice.

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]

Cognitive behavioral therapy for insomnia (CBT-I) significantly improves insomnia symptoms, with 36% of patients achieving remission compared to only 16.9% in control groups, indicating its efficacy for those with comorbid conditions.

CBT-I shows medium to large effect sizes for various sleep parameters, such as sleep efficiency and sleep onset latency, and has a small positive effect on comorbid symptoms, particularly benefiting patients with psychiatric conditions more than those with medical conditions.

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]

Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective for many, but 30% to 40% of patients do not respond, highlighting a need for additional treatment options.

This review suggests that combining CBT-I with exercise could enhance insomnia treatment outcomes, as both interventions have shown positive effects on sleep, although clinical trials on their combined effects are currently lacking.

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]

Cognitive Behavioral Therapy for insomnia (CBT-i) is an effective first-line treatment for chronic insomnia, showing significant improvements in sleep onset latency (SOL) by about 19 minutes and wake after sleep onset (WASO) by about 26 minutes based on a review of 20 studies involving 1162 participants.

The benefits of CBT-i, which includes techniques like cognitive therapy and sleep hygiene, appear to be sustained over time, and importantly, no adverse effects were reported, making it a safe alternative to pharmacological treatments.

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]

This randomized clinical trial aims to evaluate the effectiveness of an app-delivered cognitive-behavioral therapy for insomnia (CBT-I) in conjunction with inpatient rehabilitation for patients with chronic musculoskeletal complaints and insomnia, with assessments planned at multiple time points up to 12 months.

The primary outcome of the study is to measure insomnia severity at 3 months, which will help determine if the app-delivered CBT-I can significantly improve sleep quality compared to usual care alone.

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]

Citations

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]