Cognitive Behavioral Therapy for Insomnia in Knee Osteoarthritis Patients
Towards PREcision MEdicine for Osteoarthritis: Added Value of Cognitive Behavioural Therapy for Insomnia.
This study tests if adding cognitive behavioral therapy for insomnia to standard care can help people with knee osteoarthritis sleep better and improve their overall quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Vrije Universiteit Brussel Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Leuven) |
| Trial ID | NCT05387473 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of cognitive behavioral therapy for insomnia (CBT-I) when integrated with best-evidence usual care for patients suffering from knee osteoarthritis (KOA). It aims to address the high prevalence of insomnia among KOA patients, which can exacerbate their symptoms and hinder effective management. By targeting insomnia as a comorbidity, the study seeks to improve overall patient outcomes and quality of life. Participants will receive CBT-I alongside standard care and information sessions to enhance their treatment experience.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45 and older who are fluent in Dutch and have a diagnosis of knee osteoarthritis and insomnia.
Not a fit: Patients currently undergoing supervised exercise therapy or joint infiltrations, or those who have received CBT-I in the past six months, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve sleep quality and overall well-being for patients with knee osteoarthritis.
How similar studies have performed: While the integration of CBT-I in osteoarthritis management is a novel approach, similar studies targeting comorbidities in chronic pain conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 45 years old or older Being a fluent Dutch speaker Commits to study requirements Knee Osteoarthritis classified using the American college of Rheumatology criteria (Knee pain + 3/6 for diagnosis): * age\>50 * morning stiffness \<30 minutes * crepitus * bony tenderness * bony enlargement * no palpable warmth Insomnia diagnosis using the DSM-5 criteria: * No shiftwork * No severe untreated sleep disorders * For at least \>3 days / week for \>3 months: \>30 minutes sleep latency and/or \>30 minutes awake after sleep onset and/or early-morning awakening with inability to return to sleep AND associated daytime symptoms Knee pain nominated by the patient as 3 or higher on a visual analogue scale on most days of the last 3 months Informed consent Exclusion Criteria: Treatment with supervised exercise therapy or joint infiltrations (e.g., corticosteroids, hyaluronic acid) or CBT-I in the preceding six months Change in any psychiatric or psychological treatment the last 3m or planned during the study period Concurrent intense psychological treatment (weekly basis) BMI \>30 Mini-Mental state examination score of 23 or lower Being on the waiting list for a knee replacement or having received knee replacement on symptomatic side Any contra-indication for exercise therapy Existing diagnose that has impact on sleep and patients are therefore unlikely to respond to CBT-I: any rheumatological condition (e.g. rheumatoid arthritis, Lupus, Sjogren's syndrome); any neurological conditions (e.g. stroke, Multiple sclerosis, Parkinson's disease), dementia or receiving cholinesterase inhibitors; cancer diagnosis in the past year and receiving chemotherapy or radiation therapy in the past year; Long-COVID or inpatient treatment for congestive heart failure within the prior six months. Having severe underlying sleep disorder (obstructive sleep apnea over AHI \>15, periodic leg movement disorder, restless leg syndrome, sleep-wake cycle disturbance, rapid eye movement behavior disorder) Being pregnant or given birth in the preceding year Having an external/ physical factor that limits the opportunity to sleep (E.g. newborn)
Where this trial is running
Leuven
- Department Rehabilitation Science — Leuven, Belgium (Recruiting)
Study contacts
- Principal investigator: Jo Nijs — Vrije Universiteit Brussel
- Study coordinator: Liesbet De Baets, PhD
- Email: liesbet.de.baets@vub.be
- Phone: 003226292010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.