Clinical trial NCT05387473: Added Value of Cognitive Behavioural Therapy for Insomnia in Persons With Knee Osteoarthritis
Official title: Towards PREcision MEdicine for Osteoarthritis: Added Value of Cognitive Behavioural Therapy for Insomnia.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Insomnia
Keywords: sleep initiation and maintenance problems
Arthritis
Pain
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorder
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
Collaborators: name: KU Leuven
name: Universitaire Ziekenhuizen KU Leuven
First posted: 2022-05-24
Enrollment: 128
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Change in Pain subscale Knee injury and Osteoarthritis Outcome Score
timeFrame: 6 months after the end of therapy
Secondary outcomes:
measure: Change in Pain subscale Knee injury and Osteoarthritis Outcome Score
timeFrame: Baseline, after 14 weeks (post-intervention), 3 months after the end of therapy, and 12 months after the end of therapy
measure: Change in impact of pain on functioning
timeFrame: 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
measure: Change in self-reported central sensitization symptoms
timeFrame: 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
measure: Change in sleep quality
timeFrame: 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
measure: Change in Dysfunctional Beliefs and Attitudes about Sleep
timeFrame: 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
measure: Change in sleep propensity
timeFrame: 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
measure: Change in pain-related fear of movement
timeFrame: 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
measure: Change in physical function
timeFrame: 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
measure: Global assessment
timeFrame: 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
measure: Change in physical activity and sleep behaviour
timeFrame: 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
measure: Change in physical activity and sleep behaviour during intervention
timeFrame: 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
measure: Change in pain intensity
timeFrame: 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
measure: Change in pain intensity during intervention
timeFrame: 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
measure: Change in insomnia Severity
timeFrame: 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
measure: Change in insomnia Severity during intervention
timeFrame: 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
measure: Change in fatigue severity
timeFrame: 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
measure: Change in fatigue severity during intervention
timeFrame: 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
measure: Change in pain catastrophizing
timeFrame: 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
measure: Change in pain catastrophizing during intervention
timeFrame: 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
measure: Change in anxiety and Depression
timeFrame: 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
measure: Change in anxiety and depression during intervention
timeFrame: 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
measure: Change in Pressure Pain Thresholds
timeFrame: Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
measure: Change in objective sleep assessed with polysomnography (PSG)
timeFrame: Baseline, after 14 weeks (post-intervention)
measure: Change in biomarkers for inflammation by blood analysis
timeFrame: Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
measure: Change in physical performance
timeFrame: Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
measure: Change in health care use
timeFrame: Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
measure: Change in productivity cost
timeFrame: Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
measure: Change in health-related quality of life
timeFrame: Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department Rehabilitation Science
Study officials:
affiliation: Vrije Universiteit Brussel
name: Jo Nijs
role: PRINCIPAL_INVESTIGATOR
References: