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

NCT05387473 | Active Not Recruiting

• 1 other identifier: FWO TBM T000521N
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

Keywords

sleep initiation and maintenance problems; Arthritis; Pain; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Pain subscale Knee injury and Osteoarthritis Outcome Score

  The pain subscale of the Knee injury and Osteoarthritis Outcome Score (KOOS) will be used as primary outcome to assess change in pain. The KOOS shows adequate content validity, internal consistency, reliability, content validity and responsiveness for age and condition relevant subscales. The pain scale consists of 9 items. A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems). The total score ranges from 0 to 36.

  6 months after the end of therapy

Secondary Outcomes (28)

• Change in Pain subscale Knee injury and Osteoarthritis Outcome Score

  Baseline, after 14 weeks (post-intervention), 3 months after the end of therapy, and 12 months after the end of therapy

• Change in impact of pain on functioning

  Baseline, after 14 weeks (post-intervention), 3 months after the end of therapy, 6 months after the end of therapy and 12 months after the end of therapy

• Change in self-reported central sensitization symptoms

  Baseline, after 14 weeks (post-intervention), 3 months after the end of therapy, 6 months after the end of therapy and 12 months after the end of therapy

• Change in sleep quality

  Baseline, after 14 weeks (post-intervention), 3 months after the end of therapy, 6 months after the end of therapy and 12 months after the end of therapy

• Change in Dysfunctional Beliefs and Attitudes about Sleep

  Baseline, after 14 weeks (post-intervention), 3 months after the end of therapy, 6 months after the end of therapy and 12 months after the end of therapy

Study Arms (2)

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

EXPERIMENTAL

18 individual sessions provided by physiotherapists, over 14 weeks.

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

Best-evidence usual care (UC) plus information sessions

ACTIVE COMPARATOR

18 individual sessions provided by physiotherapists, over 14 weeks.

Behavioral: Best-evidence usual care (UC) plus information sessions

Interventions

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

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

Best-evidence usual care (UC) plus information sessions 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.

Best-evidence usual care (UC) plus information sessions

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• KU Leuven: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (1)

Department Rehabilitation Science

Leuven, Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Sleep Initiation and Maintenance Disorders; Arthritis; Pain; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jo Nijs

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 24, 2022
• Study Start: May 25, 2022
• Primary Completion: March 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)