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

Key facts

Who runs it
Vrije Universiteit Brussel
Where
Belgium1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
129 people, planned
Started
1 Feb 2025
Expected to end
Dec 2027
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Standard Care CBTi
  • Stepped Care CBTi
Record updated
19 August 2026

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

  • Stepped Care CBTiTreatment being tested

    Stepped Care Cognitive Behavioral Therapy for Insomnia (CBTi). The stepped care approach in CBTi entails a two-step approach. Participants in this group all receive an initial entry level session of 1 hour delivered by a trained physiotherapist. Whether or not they are afterwards referred to the second step (standard care CBTi) depends on their remission status.

    Treatment: Standard Care CBTi and Stepped Care CBTi

  • Standard Care CBTiExisting treatment, for comparison

    Standard Care CBTi will take 10 weeks, during which the participant will have access to an online platform and will have and 2 online face-to-face talks with a certified psychologist. For the online lessons, a validated and effective online intervention will be used. The construction of this online intervention was based on self-help materials, research of the literature, and pa-tient interviews. Standard Care CBTi consists of weekly online webinars and/or exercises and incorporates elements commonly used in face-to-face CBTi. The 10-week program covers the follow-ing topics: the sleep-wake system, how sleep problems arise, bed restriction, reprogram the internal clock, daily habits, stress system, etc. The intervention is supported by online coaching: at two specific time points (around week 3 and week 8) the therapist and participant will have a face-to-face online meeting.

  • Usual Care groupNo study treatment, for comparison

    In the usual care group, participants will be asked to continue as usual regarding their sleep behavior and pain-related medical use. They can follow regular care for their pain- and/or sleep problem as recommended by their general practitioner. Their medical use and behavior will be monitored. Once data collection has ended in a usual care participant (i.e., at 12 months follow-up), they are offered a Standard Care CBTi intervention.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Time to Step Up to Stepped Care: A Novel Strategy for Cognitive Behavioral Therapy for Insomnia in Chronic Spinal Pain - a Randomized Controlled Trial
Fit questions
Built from NCT06771856, who can take part
Record updated
19 August 2026