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Time to Step Up to Stepped Care: A Novel Strategy for Cognitive Behavioral Therapy for Insomnia in Chronic Spinal Pain

Study acronym: StepUp
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Mar 2027 → Dec 2027
See other at-risk trials from Vrije Universiteit Brussel

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Mar 2027 to Dec 2027
    • Study completion pushed from Sep 2027 to Dec 2027
    v4
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2025 to Feb 1, 2025
    • Site details revised
    v3
  3. Minor Study title shortened, about 5 wordsv2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Chronic spinal pain (i.e., chronic neck pain and chronic low back pain) are highly prevalent, and are known for their immens personal and socio-economic burden. Chronic spinal pain is impacted by many aspects, and in this story, insomnia plays an important role. Clinical insomnia symptoms are very common in people suffering from chronic spinal pain, and the presence of insomnia is known to aggravate the chronic spinal pain symptoms. While research shows that tackling insomnia in these patients is helpful for these patients, the availability of cognitive behavioral therapy, the golden standard to treat insomnia, is unfortunately extremely limited. Therefore this study aims to investigate whether a stepped care approach to cognitive behavioral therapy is a solution to this problem.
Trial Details
NCT Number NCT06771856
Lead Sponsor Vrije Universiteit Brussel
Conditions
(from sponsor)
Chronic Spinal Pain
Related terms Sleep Initiation and Maintenance Disorders
Enrollment 129 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov