Osteoarthritis, KneePREMEONCT05387473
Added Value of Cognitive Behavioural Therapy for Insomnia in Persons With Knee Osteoarthritis
A study of Osteoarthritis, Knee and Insomnia, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteBelgium
- Study dates
- 25 May 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Towards PREcision MEdicine for Osteoarthritis: Added Value of Cognitive Behavioural Therapy for Insomnia.
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
- Being tested
- Cognitive behavioral therapy for insomnia (CBT-I) integrated in best-evidence usual care (CBTi-UC), Best-evidence usual care (UC) plus information sessions
- Keywords
- sleep initiation and maintenance problems, Arthritis, Pain, Sleep Disorders, Intrinsic, Dyssomnias, Sleep Wake Disorder
- Medical subject headings
- Osteoarthritis, Knee, Sleep Initiation and Maintenance Disorders, Arthritis, Pain, Sleep Disorders, Intrinsic, Dyssomnias, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy for insomnia (CBT-I) integrated in best-evidence usual care (CBTi-UC)Behavioural
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 sessionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Best-evidence usual care (UC) plus information sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after the end of therapy
Secondary outcomes (28)
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.
Measured: 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
The Brief Pain Inventory (BPI) evaluates the impact of pain on functioning. The BPI measures how much pain interferes with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep on an 11-point Numeric Rating Scale (ranging from 0-10).
Measured: 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
The Central Sensitization Inventory investigates self-reported central sensitization symptoms. Score ranges from 0 to 100, with higher scores indicating more self-reported symptoms of central sensitization.
Measured: 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
The Pittsburg Sleep Quality Index investigates self-reported perceived sleep quality. Score ranges from 0 to 21, 0 indicating no difficulty and 21 indicating severe sleep difficulties.
Measured: 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
The Dysfunctional Beliefs and Attitudes about Sleep questionnaire investigates self-reported dysfunctional beliefs and attitudes about sleep. Score ranges from 0 to 10. Scores above 4 indicate unrealistic expectations for sleep or unrealistic thoughts about sleep.
Measured: 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 propensity
The Epworth Sleepiness Scale investigates self-reported sleep propensity. Score ranges from 0 to 24, with 0 indicating normal daytime sleepiness and 24 indicating severe excessive daytime sleepiness.
Measured: 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 pain-related fear of movement
The Tampa Scale for Kinesiophobia - 17 item version investigates pain-related fear of movement and (re)injury. Each item is scored on a 4-point Likert Scale, ranging from one ("strongly disagree") to four ("strongly agree"). The total score ranges between 17 and 68, with higher values reflecting greater fear of movement
Measured: 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 physical function
Change in physical function is assessed with the function in daily living subscale of the Knee injury. and Osteoarthritis Outcome Score
Measured: 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
Global assessment
The patient global assessment is a recommended question in clinical trials of rehabilitation interventions for OA and it measures the improvement or deterioration of their condition since baseline, and therefore since the intervention has started. It will be assessed by patients on a 7-point Likert scale (very much improved, much improved, slightly improved, not changed, slightly worsened, much worsened, and vastly worsened).
Measured: 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 physical activity and sleep behaviour
Using Fitbit Sense, physical activity measures such as the number of steps as well as sleep parameters will be retrieved with custom-made algorithms to quantify daily movement/sleep behaviours
Measured: 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 physical activity and sleep behaviour during intervention
Using Fitbit Sense, physical activity measures such as the number of steps as well as sleep parameters will be retrieved with custom-made algorithms to quantify daily movement/sleep behaviours
Measured: after intervention week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14
Change in pain intensity
The Numeric Rating Scale for pain assesses the intensity of pain. It is an 11-point scale that requires the patient to select a number ranging from zero ("no pain") to ten ("worst possible pain"). The average and worst pain intensity in last week is questioned.
Measured: 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 pain intensity during intervention
The Numeric Rating Scale for pain assesses the intensity of pain. It is an 11-point scale that requires the patient to select a number ranging from zero ("no pain") to ten ("worst possible pain"). The average and worst pain intensity in last week is questioned.
Measured: Bafter intervention week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14
Change in insomnia Severity
The Insomnia Severity Index investigates self-reported insomnia severity. Score ranges from 0 to 28, with 0 indicating no clinically significant insomnia and 28 indicating severe clinical insomnia.
Measured: 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 insomnia Severity during intervention
The Insomnia Severity Index investigates self-reported insomnia severity. Score ranges from 0 to 28, with 0 indicating no clinically significant insomnia and 28 indicating severe clinical insomnia.
Measured: after intervention week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14
Change in fatigue severity
The Brugmann Fatigue Scale investigates self-reported fatigue severity. Score ranges from 0 to 24, with higher scores indicating higher subjective levels of fatigue.
Measured: 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 fatigue severity during intervention
The Brugmann Fatigue Scale investigates self-reported fatigue severity. Score ranges from 0 to 24, with higher scores indicating higher subjective levels of fatigue.
Measured: after intervention week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14
Change in pain catastrophizing
The Pain Catastrophizing Scale assesses negative thoughts and feelings when experiencing pain. Each item is scored from zero ("not at all") to four ("all the time"). Its total score ranges between 0 and 52, with a higher total score indicating higher levels of pain catastrophizing.
Measured: 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 pain catastrophizing during intervention
The Pain Catastrophizing Scale assesses negative thoughts and feelings when experiencing pain. Each item is scored from zero ("not at all") to four ("all the time"). Its total score ranges between 0 and 52, with a higher total score indicating higher levels of pain catastrophizing.
Measured: after intervention week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14
Change in anxiety and Depression
The Hospital Anxiety and Depression rating scale investigates self-reported affective symptoms. Score ranges from 0 to 21, with 0 indicating absence of depression or anxiety and 21 indicating the presence of depression or anxiety.
Measured: Baseline, after 14 weeks (post-intervention), 3 months after the end of therapy, 6 months after the end of therapyand 12 months after the end of therapy
Change in anxiety and depression during intervention
The Hospital Anxiety and Depression rating scale investigates self-reported affective symptoms. Score ranges from 0 to 21, with 0 indicating absence of depression or anxiety and 21 indicating the presence of depression or anxiety.
Measured: after intervention week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14
Change in Pressure Pain Thresholds
Pressure Pain Thresholds are measured with a digital pressure algometer (Wagner Instruments), both at symptomatic level (knee) and at remote sites (i.e. secondary hyperalgesia).
Measured: Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
Change in objective sleep assessed with polysomnography (PSG)
Participants will be monitored in the comfort of their own home by ambulatory PSG, one night at echt timepoint. PSG will provide sleep related outcomes (time in bed, total sleep time, sleep onset latency, wake duration after sleep onset, early morning awakening, sleep staging N1, N2, N3, REM in durations and % of total sleep time, sleep efficiency, respiratory parameters, myoclonic activity).
Measured: Baseline, after 14 weeks (post-intervention)
Change in biomarkers for inflammation by blood analysis
A relevant panel of biomarkers for chronic low-grade inflammation, modulation of inflammation and pain will be investigated (ultra-sensitivity ELISA for hsCRP, interleukin (IL)1β, IL1RA, IL6, IL8, IL10, MCP1, tumor necrosis factor (TNF-α, sTNFR1\&2, CXCL-10, CX3CL1). Blood sampling will be performed at the hospital after overnight fasting.
Measured: Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
Change in physical performance
30sec chair stand test to test leg strength and endurance.While monitoring the participant's performance to ensure proper form, the tester silently counts the completion of each correct stand. The score is the total number of stands within 30 seconds
Measured: Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
Change in health care use
Health care use (including co-interventions) will be recorded using the Medical Consumption Questionnaire, a generic instrument for measuring total, (in-)direct medical consumption. This questionnaire is easy-to-use and generates valid data.
Measured: Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
Change in productivity cost
The Productivity Cost Questionnaire will be used to obtain data regarding productivity losses. This questionnaire is easy-to-use and generate valid data.
Measured: Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
Change in health-related quality of life
The EQ-5D-5L will be used to assess health-related quality of life and to calculated utility health states for the cost-utility analysis. The EQ-5D-5L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The descriptive system comprises five dimensions, with each dimension consisting of 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. Higher scores indicate a higher quality of life
Measured: Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start25 May 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Jo Nijs, Vrije Universiteit Brussel
- Investigators
- Jo Nijs, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387473
- Sponsor's protocol ID
- FWO TBM T000521N
- Acronym
- PREMEO
- Status last verified
- Aug 2025
- First submitted
- 12 May 2022
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards PREcision MEdicine for Osteoarthritis: Added Value of Cognitive Behavioural Therapy for Insomnia.
- ClinicalTrials.gov ID
- NCT05387473
- Acronym / sponsor ID
- PREMEO / FWO TBM T000521N
- Conditions
- Osteoarthritis, Knee, Insomnia
- Keywords
- sleep initiation and maintenance problems, Arthritis, Pain, Sleep Disorders, Intrinsic, Dyssomnias, Sleep Wake Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Collaborators
- KU Leuven, Universitaire Ziekenhuizen KU Leuven
- Study start
- 25 May 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cognitive behavioral therapy for insomnia (CBT-I) integrated in best-evidence usual care (CBTi-UC) | Experimental | Behavioral: Cognitive behavioral therapy for insomnia (CBT-I) integrated in best-evidence usual care (CBTi-UC)18 individual sessions provided by physiotherapists, over 14 weeks. |
| Best-evidence usual care (UC) plus information sessions | Active comparator | Behavioral: Best-evidence usual care (UC) plus information sessions18 individual sessions provided by physiotherapists, over 14 weeks. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | cognitive behavioral therapy for insomnia (CBT-I) integrated in best-evidence usual care (CBTi-UC) |
| Best-evidence usual care (UC) plus information sessionsIn 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. | Behavioural | Best-evidence usual care (UC) plus information sessions |
Primary outcome
Change in Pain subscale Knee injury and Osteoarthritis Outcome Score
Time frame: 6 months after the end of therapy
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.
28 secondary outcomes
Change in Pain subscale Knee injury and Osteoarthritis Outcome Score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 propensity
Time frame: 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 pain-related fear of movement
Time frame: 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 physical function
Time frame: 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
Global assessment
Time frame: 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 physical activity and sleep behaviour
Time frame: 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 physical activity and sleep behaviour during intervention
Time frame: after intervention week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14
Change in pain intensity
Time frame: 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 pain intensity during intervention
Time frame: Bafter intervention week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14
Change in insomnia Severity
Time frame: 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 insomnia Severity during intervention
Time frame: after intervention week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14
Change in fatigue severity
Time frame: 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 fatigue severity during intervention
Time frame: after intervention week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14
Change in pain catastrophizing
Time frame: 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 pain catastrophizing during intervention
Time frame: after intervention week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14
Change in anxiety and Depression
Time frame: Baseline, after 14 weeks (post-intervention), 3 months after the end of therapy, 6 months after the end of therapyand 12 months after the end of therapy
Change in anxiety and depression during intervention
Time frame: after intervention week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12, week 13, week 14
Change in Pressure Pain Thresholds
Time frame: Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
Change in objective sleep assessed with polysomnography (PSG)
Time frame: Baseline, after 14 weeks (post-intervention)
Change in biomarkers for inflammation by blood analysis
Time frame: Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
Change in physical performance
Time frame: Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
Change in health care use
Time frame: Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
Change in productivity cost
Time frame: Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
Change in health-related quality of life
Time frame: Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jo Nijs principal investigator
Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Osteoarthritis, Knee and Insomnia, run by Vrije Universiteit Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain subscale Knee injury and Osteoarthritis Outcome Score (time frame: 6 months after the end of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.