A new approach to cognitive behavioral therapy for insomnia in patients with chronic spinal pain
Time to Step Up to Stepped Care: A Novel Strategy for Cognitive Behavioral Therapy for Insomnia in Chronic Spinal Pain - a Randomized Controlled Trial
This study is testing a new way of providing cognitive behavioral therapy for insomnia to see if it helps people with chronic spinal pain sleep better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 129 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Vrije Universiteit Brussel Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT06771856 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with moderate insomnia and chronic spinal pain lasting at least three months.
Not a fit: Patients with severe underlying sleep disorders, significant psychological conditions, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide effective treatment for insomnia in patients with chronic spinal pain, potentially alleviating both conditions.
How similar studies have performed: While the approach is innovative, previous studies have shown that addressing insomnia can positively impact chronic pain management, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Brussels
- Vrije Universiteit Brussel — Brussels, Belgium (Recruiting)
Study contacts
- Study coordinator: Anneleen Malfliet, PhD
- Email: StepUpStudy@vub.be
- Phone: 003224774531
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.