Back to resultsAdded Value of Cognitive Behavioural Therapy for Insomnia in Persons With Knee Osteoarthritis (PREMEO)
Primary Purpose
Osteoarthritis, Knee, Insomnia
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cognitive behavioral therapy for insomnia (CBT-I) integrated in best-evidence usual care (CBTi-UC)
Best-evidence usual care (UC) plus information sessions
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring sleep initiation and maintenance problems, Arthritis, Pain, Sleep Disorders, Intrinsic, Dyssomnias, Sleep Wake Disorder
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)
Sites / Locations
- Department Rehabilitation ScienceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
cognitive behavioral therapy for insomnia (CBT-I) integrated in best-evidence usual care (CBTi-UC)
Best-evidence usual care (UC) plus information sessions
Arm Description
18 individual sessions provided by physiotherapists, over 14 weeks.
18 individual sessions provided by physiotherapists, over 14 weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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.
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.
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.
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.
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
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
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).
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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.
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
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.
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.
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
Full Information
NCT ID
NCT05387473
First Posted
May 12, 2022
Last Updated
June 3, 2022
Sponsor
Vrije Universiteit Brussel
Collaborators
KU Leuven, Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT05387473
Brief Title
Added Value of Cognitive Behavioural Therapy for Insomnia in Persons With Knee Osteoarthritis
Acronym
PREMEO
Official Title
Towards PREcision MEdicine for Osteoarthritis: Added Value of Cognitive Behavioural Therapy for Insomnia.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
November 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel
Collaborators
KU Leuven, Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Insomnia
Keywords
sleep initiation and maintenance problems, Arthritis, Pain, Sleep Disorders, Intrinsic, Dyssomnias, Sleep Wake Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cognitive behavioral therapy for insomnia (CBT-I) integrated in best-evidence usual care (CBTi-UC)
Arm Type
Experimental
Arm Description
18 individual sessions provided by physiotherapists, over 14 weeks.
Arm Title
Best-evidence usual care (UC) plus information sessions
Arm Type
Active Comparator
Arm Description
18 individual sessions provided by physiotherapists, over 14 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioral therapy for insomnia (CBT-I) integrated in best-evidence usual care (CBTi-UC)
Intervention Description
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
Intervention Name(s)
Best-evidence usual care (UC) plus information sessions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pain subscale Knee injury and Osteoarthritis Outcome Score
Description
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.
Time Frame
6 months after the end of therapy
Secondary Outcome Measure Information:
Title
Change in Pain subscale Knee injury and Osteoarthritis Outcome Score
Description
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.
Time Frame
Baseline, after 14 weeks (post-intervention), 3 months after the end of therapy, and 12 months after the end of therapy
Title
Change in impact of pain on functioning
Description
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).
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
Title
Change in self-reported central sensitization symptoms
Description
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.
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
Title
Change in sleep quality
Description
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.
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
Title
Change in Dysfunctional Beliefs and Attitudes about Sleep
Description
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.
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
Title
Change in sleep propensity
Description
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.
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
Title
Change in pain-related fear of movement
Description
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
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
Title
Change in physical function
Description
Change in physical function is assessed with the function in daily living subscale of the Knee injury. and Osteoarthritis Outcome Score
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
Title
Global assessment
Description
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).
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
Title
Change in physical activity and sleep behaviour
Description
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
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
Title
Change in physical activity and sleep behaviour during intervention
Description
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
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
Title
Change in pain intensity
Description
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.
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
Title
Change in pain intensity during intervention
Description
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.
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
Title
Change in insomnia Severity
Description
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.
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
Title
Change in insomnia Severity during intervention
Description
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.
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
Title
Change in fatigue severity
Description
The Brugmann Fatigue Scale investigates self-reported fatigue severity. Score ranges from 0 to 24, with higher scores indicating higher subjective levels of fatigue.
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
Title
Change in fatigue severity during intervention
Description
The Brugmann Fatigue Scale investigates self-reported fatigue severity. Score ranges from 0 to 24, with higher scores indicating higher subjective levels of fatigue.
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
Title
Change in pain catastrophizing
Description
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.
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
Title
Change in pain catastrophizing during intervention
Description
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.
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
Title
Change in anxiety and Depression
Description
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.
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
Title
Change in anxiety and depression during intervention
Description
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.
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
Title
Change in Pressure Pain Thresholds
Description
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).
Time Frame
Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
Title
Change in objective sleep assessed with polysomnography (PSG)
Description
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).
Time Frame
Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
Title
Change in biomarkers for inflammation by blood analysis
Description
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.
Time Frame
Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
Title
Change in physical performance
Description
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
Time Frame
Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
Title
Change in health care use
Description
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.
Time Frame
Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
Title
Change in productivity cost
Description
The Productivity Cost Questionnaire will be used to obtain data regarding productivity losses. This questionnaire is easy-to-use and generate valid data.
Time Frame
Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
Title
Change in health-related quality of life
Description
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
Time Frame
Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liesbet De Baets, PhD
Phone
003226292010
Email
liesbet.de.baets@vub.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jo Nijs
Organizational Affiliation
Vrije Universiteit Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department Rehabilitation Science
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline Labie, MSc
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Added Value of Cognitive Behavioural Therapy for Insomnia in Persons With Knee Osteoarthritis
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