Added Value of Cognitive Behavioural Therapy for Insomnia in Persons With Knee Osteoarthritis

NCT ID: NCT05387473

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-25
• Study Completion Date: 2026-11-30

Brief Summary

Knee osteoarthritis (KOA) is the leading and fastest increasing cause of disability in older adults. It is a serious health issue related with a high health care utilisation. The first-line KOA management is nonsurgical care, with education and exercise therapy as key elements. Nevertheless, treatment effects of exercise therapy and behavioral pain management on improvements in pain, function and quality of life are small to moderate at best. This shows that there is an urgent need for better KOA care. The innovative solution may lie in thinking beyond joints, by targeting KOA subgroups through comorbidity-specific interventions, which fits well in the global move towards precision medicine. With a prevalence rate up to 50%, the presence of insomnia symptoms is a highly prevalent KOA comorbidity, contributing to symptom severity. If left untreated, it represents a barrier for effective conservative management. Since insomnia is nowadays hardly addressed in the often joint-targeted KOA care, the scientific objectives of the study are to assess 1) if cognitive behavioral therapy for insomnia (CBT-I) integrated in best-evidence usual care, consisting of education and exercise therapy, (CBTi-UC) is more effective than best-evidence usual care alone (UC), i.e. education and exercise therapy, at 6 months follow-up in improving clinical outcomes and 2) if CBTi-UC is more cost-effective than UC in KOA patients with comorbid insomnia.

Conditions

Osteoarthritis, Knee; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

cognitive behavioral therapy for insomnia (CBT-I) integrated in best-evidence usual care (CBTi-UC)

18 individual sessions provided by physiotherapists, over 14 weeks.

Group Type: EXPERIMENTAL

Cognitive behavioral therapy for insomnia (CBT-I) integrated in best-evidence usual care (CBTi-UC)

Intervention Type: BEHAVIORAL

In the first two weeks, the participants will receive three sessions of education and advice based on current best-practice guidelines. In the following three weeks, the participants will be provided with once weekly exercise therapy and once weekly CBT-I. This is then spread out more over the next five weeks in which participants will receive once weekly sessions of either CBT-I or exercise therapy in alternating order. In the last four weeks of the intervention period, the participants will receive once weekly exercise therapy.

Best-evidence usual care (UC) plus information sessions

18 individual sessions provided by physiotherapists, over 14 weeks.

Group Type: ACTIVE_COMPARATOR

Best-evidence usual care (UC) plus information sessions

Intervention Type: BEHAVIORAL

In the first two weeks, the participants will receive three sessions of education and advice based on current best-practice guidelines. In the following three weeks, the participants will be provided with once weekly exercise therapy and once weekly general information sessions (general education sessions in line with recommendations from best-practice guidelines and recent evidence). This is then spread out more over the next five weeks in which participants will receive once weekly sessions of either CBT-I or exercise therapy in alternating order. In the last four weeks of the intervention period, the participants will receive once weekly exercise therapy.

Interventions

Cognitive behavioral therapy for insomnia (CBT-I) integrated in best-evidence usual care (CBTi-UC)

In the first two weeks, the participants will receive three sessions of education and advice based on current best-practice guidelines. In the following three weeks, the participants will be provided with once weekly exercise therapy and once weekly CBT-I. This is then spread out more over the next five weeks in which participants will receive once weekly sessions of either CBT-I or exercise therapy in alternating order. In the last four weeks of the intervention period, the participants will receive once weekly exercise therapy.

Intervention Type: BEHAVIORAL

Best-evidence usual care (UC) plus information sessions

In the first two weeks, the participants will receive three sessions of education and advice based on current best-practice guidelines. In the following three weeks, the participants will be provided with once weekly exercise therapy and once weekly general information sessions (general education sessions in line with recommendations from best-practice guidelines and recent evidence). This is then spread out more over the next five weeks in which participants will receive once weekly sessions of either CBT-I or exercise therapy in alternating order. In the last four weeks of the intervention period, the participants will receive once weekly exercise therapy.

Intervention Type: BEHAVIORAL

Eligibility 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)

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: collaborator

Vrije Universiteit Brussel

OTHER

Sponsor Role: lead

Responsible Party

Jo Nijs

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jo Nijs

Role: PRINCIPAL_INVESTIGATOR

Vrije Universiteit Brussel

Locations

Department Rehabilitation Science

Leuven, Leuven, Belgium

Countries

Belgium

Other Identifiers

FWO TBM T000521N

Identifier Type: -

Identifier Source: org_study_id