Towards PREcision MEdicine for Osteoarthritis: Added Value of Cognitive Behavioural Therapy for Insomnia.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Vrije Universiteit Brussel
- Enrollment
- 128
- Locations
- 1
- Primary Endpoint
- Change in Pain subscale Knee injury and Osteoarthritis Outcome Score
- Status
- Active, not recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
Jo Nijs
Professor
Vrije Universiteit Brussel
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):
- •morning stiffness \<30 minutes
- •bony tenderness
- •bony enlargement
- •no palpable warmth
- •Insomnia diagnosis using the DSM-5 criteria:
- •No shiftwork
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)
- •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)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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 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)
- Change in productivity cost(Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy)
- Change in health-related quality of life(Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy)
- 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 physical function(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(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(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 anxiety and Depression(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(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(Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy)
- Change in biomarkers for inflammation by blood analysis(Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy)
- Change in physical performance(Baseline, after 14 weeks (post-intervention), and 12 months after the end of therapy)
- Change in pain-related fear of movement(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(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(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(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(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(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 physical activity and sleep behaviour during intervention(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 insomnia Severity during intervention(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 objective sleep assessed with polysomnography (PSG)(Baseline, after 14 weeks (post-intervention))
- Change in health care use(Baseline, after 14 weeks (post-intervention), 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 propensity(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(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(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)