Time to Step Up to Stepped Care: A Novel Strategy for Cognitive Behavioral Therapy for Insomnia in Chronic Spinal Pain
Recruiting now · Not applicable
Conditions studied: Chronic Spinal Pain
In brief
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.
Key facts
- Study ID
- NCT06771856
- Run by
- Vrije Universiteit Brussel
- People needed
- 129
- Starts
- 2025-02-01
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2025-02-14
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Vrije Universiteit Brussel — Brussels, Belgium (enrolling)
Full record on ClinicalTrials.gov
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