Insomnia Clinical Trials

Find Insomnia Clinical Trials Near You

Time to Step Up to Stepped Care: A Novel Strategy for Cognitive Behavioral Therapy for Insomnia in Chronic Spinal Pain - a Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
Vrije Universiteit Brussel
RECRUITING
Brussels
Contact Information
Primary
Anneleen Malfliet, PhD
StepUpStudy@vub.be
003224774531
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2027-09
Participants
Target number of participants: 129
Treatments
Experimental: Stepped Care CBTi
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.
Active_comparator: Standard Care CBTi
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.
No_intervention: Usual Care group
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.
Related Therapeutic Areas
Sponsors
Leads: Vrije Universiteit Brussel

This content was sourced from clinicaltrials.gov