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

Study acronym: PREMEO
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Mar 2026 → Dec 2026
See other at-risk trials from Vrije Universiteit Brussel

Record History

  1. Notable Primary completion pushed from Mar 2026 to Dec 2026
    • Study completion date: Nov 2026 to Dec 2026
    v7
  2. Notable Primary completion date: May 2025 to Mar 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Nov 2025 to Nov 2026
    • Site details revised
    v6
  3. Minor Secondary endpoints: details revised at 1 of 28 entriesv5
  4. Notable Primary completion date: May 2024 to May 2025v4
  5. Minor Re-verified, no change to tracked fieldsv3
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2022 to May 25, 2022
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05387473
Lead Sponsor Vrije Universiteit Brussel
Collaborators: KU Leuven, Universitaire Ziekenhuizen KU Leuven
Conditions
(from sponsor)
Osteoarthritis, Knee, Insomnia
Related terms Arthritis, Dyssomnias, Osteoarthritis, Knee, Pain, Sleep Disorders, Intrinsic, Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
Enrollment 128 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov