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 trial tests whether combining a sleep improvement program with exercise reduces knee pain more effectively than exercise alone. It targets individuals with knee osteoarthritis who also experience insomnia. Participants will receive either personalized exercise coaching with sleep therapy (Cognitive Behavioral Therapy for Insomnia) or just exercise coaching. The study seeks individuals with persistent knee pain and sleep issues, without recent changes in pain or sleep medication. As an unphased trial, it offers a unique opportunity to explore innovative treatment combinations for managing knee pain and insomnia.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive Behavioral Therapy for Insomnia (CBT-I) is safe for individuals with knee osteoarthritis. One study found that CBT-I reduced pain and improved sleep without major side effects. Specifically, about one-third of patients experienced a 30% reduction in pain, indicating it is well-tolerated.

For the personalized exercise program, studies have demonstrated that customized exercises are safe and effective for managing knee osteoarthritis. Research confirms that these programs improve health and are generally safe. No significant negative effects have been reported, indicating they are usually well-tolerated by patients.

Both treatments have consistently shown positive safety results, with no major negative events reported. This makes them promising options for those considering participation in the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Move and Snooze program for knee osteoarthritis because it combines personalized exercise with Cognitive Behavioral Therapy for Insomnia (CBT-I). This approach is unique as it targets both physical and sleep-related aspects, potentially offering a more comprehensive improvement in quality of life compared to standard treatments like pain relievers or physical therapy alone. By addressing insomnia, the treatment could enhance recovery and reduce the perception of pain, which is not the primary focus of traditional therapies. Meanwhile, the personalized exercise program stands out by tailoring activities to individual needs, which could lead to better adherence and outcomes than generic exercise recommendations.

What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?

Research has shown that cognitive behavioral therapy for insomnia (CBT-I), which participants in this trial may receive, can help reduce pain in people with knee osteoarthritis. In one study, one-third of patients reported a 30% reduction in pain after CBT-I. Another study found that CBT-I improved sleep by reducing the time spent awake after falling asleep. Participants in this trial may also receive a personalized exercise program, which has proven effective in reducing pain and improving knee function. Combining CBT-I with exercise, as in the "Move and Snooze" program arm of this trial, might lead to even better results, as each offers unique benefits. ^{1 2 4 6 7}

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 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]

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 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]

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-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]

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]

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) 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) 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) 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25623343/

Cognitive-behavioral therapy for insomnia in knee osteoarthritis Patients in both groups reported significant and comparable reductions in pain over 6 months, with one-third reporting a 30% reduction in pain severity.

2. acrjournals.onlinelibrary.wiley.com acrjournals.onlinelibrary.wiley.com/doi/abs/10.1002/art.39048

Cognitive–Behavioral Therapy for Insomnia in Knee ... Patients in the CBT-I group had significantly greater reductions in wake after sleep onset (WASO), as measured by patient diary and PSG.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05387473

NCT05387473 | Added Value of Cognitive Behavioural ... The scientific objectives of the study are to assess 1) if cognitive behavioral therapy for insomnia (CBT-I) integrated in best-evidence usual care.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9853196/

Impact of cognitive behavior therapy on osteoarthritis ... During the follow-up period, we found that the use of CBT improved the severity of pain, insomnia, and depression. Nevertheless, sleep efficiency, fatigue, and ...

5. pure.johnshopkins.edu pure.johnshopkins.edu/en/publications/cognitive-behavioral-therapy-for-insomnia-in-knee-osteoarthritis--4

Cognitive-behavioral therapy for insomnia in knee ... Patients in the CBT-I group had significantly greater reductions in wake after sleep onset (WASO), as measured by patient diary and PSG.

6. academic.oup.com academic.oup.com/sleep/article/48/Supplement_1/A250/8134940

0575 Efficacy of Cognitive Behavioral Therapy for Insomnia in ... The study demonstrates that CBT-I decreases insomnia severity in patients recovering from knee or hip joint arthroplasty primarily due to ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2665913123000675

Measures of sleep are not routinely captured in trials ... Measures of sleep are not routinely captured in trials assessing treatment outcomes in knee osteoarthritis - A scoping systematic review and call to action.