NCT06771856 Time to Step Up to Stepped Care: A Novel Strategy for Cognitive Behavioral Therapy for Insomnia in Chronic Spinal Pain
| NCT ID | NCT06771856 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vrije Universiteit Brussel |
| Condition | Chronic Spinal Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 129 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 129 participants in total. It began in 2025-02-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Anneleen Malfliet, PhD
PRINCIPAL INVESTIGATOR
Vrije Universiteit Brussel
Frequently Asked Questions
Who can join the NCT06771856 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Spinal Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06771856 currently recruiting?
Yes, NCT06771856 is actively recruiting participants. Contact the research team at StepUpStudy@vub.be for enrollment information.
Where is the NCT06771856 trial being conducted?
This trial is being conducted at Brussels, Belgium.
Who is sponsoring the NCT06771856 clinical trial?
NCT06771856 is sponsored by Vrije Universiteit Brussel. The principal investigator is Anneleen Malfliet, PhD at Vrije Universiteit Brussel. The trial plans to enroll 129 participants.