A new approach to cognitive behavioral therapy for insomnia in patients with chronic spinal pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates a stepped care approach to cognitive behavioral therapy (CBT) for treating insomnia in individuals suffering from chronic spinal pain. Chronic spinal pain is a prevalent condition that significantly impacts quality of life and is often exacerbated by insomnia. The study aims to determine whether this novel approach can improve access to effective CBT for insomnia, which is currently limited. Participants will receive either standard care CBT or the stepped care CBT intervention, allowing for a comparison of outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Insomniacs (18-65y/o), with an Insomnia Severity Index score ≥15 (i.e., at least moderate insomnia) suffering from CSP, defined as non-specific spinal pain of at least 3 month's duration, currently seeking care for CSP, with a pain severity of ≥3/10 on the Brief Pain Inventory are recruited. In the absence of other intrin-sic sleep disorders and shift work, insomnia is defined as \>30 minutes sleep latency and/or minutes awake after sleep onset for \>3 days/week for \>3 months.

Exclusion Criteria:

Having severe underlying sleep pathology, being pregnant or given birth in the preceding year, suffering from a chronic condition which is currently causing other pain complaints, or suffering from severe psychological or psychiatric dis-eases, dementia or cognitive impairment. Eligible participants are asked not to start new treatments or medication, and continuing the usual non-physical thera-py care (6 weeks prior to and during study participation to obtain a steady state). A sleep-related anamnesis and a polysomnography assessment are performed to determine and exclude severe underlying comorbid sleep disorders.

Where it's running

• Vrije Universiteit Brussel
  Brussels, Belgium Recruiting

Study contacts

• Principal investigator: Anneleen Malfliet, PhD — Vrije Universiteit Brussel
• Study coordinator: Anneleen Malfliet, PhD
• Email: StepUpStudy@vub.be
• Phone: 003224774531

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.