Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06771856

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

Led by Vrije Universiteit Brussel · Updated on 2025-02-14

129

Participants Needed

1

Research Sites

134 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 65 years
  • Moderate to severe insomnia with an Insomnia Severity Index score of 15 or higher
  • Chronic spinal pain lasting at least 3 months
  • Currently seeking care for chronic spinal pain
  • Pain severity of 3 or higher on the Brief Pain Inventory
  • Insomnia defined as sleep latency over 30 minutes or awake after sleep onset more than 3 nights per week for over 3 months
  • No other intrinsic sleep disorders or shift work
Not Eligible

You will not qualify if you...

  • Severe underlying sleep disorders confirmed by polysomnography
  • Pregnant or gave birth within the previous year
  • Chronic conditions causing other pain complaints
  • Severe psychological or psychiatric disorders
  • Dementia or cognitive impairment
  • Starting new treatments or medications during study participation
  • Unable to maintain usual non-physical therapy care for at least 6 weeks prior and during study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Vrije Universiteit Brussel

Brussels, Belgium, 1090

Actively Recruiting

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Research Team

A

Anneleen Malfliet, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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