Cognitive Behavioral Therapy for Chronic Spinal Pain and Insomnia
Time to Step Up to Stepped Care: A Novel Strategy for Cognitive Behavioral Therapy for Insomnia in Chronic Spinal Pain
Recruiting
N/AInterventional Study
Chronic Spinal Pain
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
129 (estimated)
Sponsor
Vrije Universiteit Brussel · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 65 who have insomnia and chronic spinal pain. Participants will receive a new approach to cognitive behavioral therapy to help improve their sleep and manage their pain.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 65 years old.
I have insomnia that is at least moderate.
I have chronic spinal pain that has lasted for at least 3 months.
I currently seek care for my chronic spinal pain.
My pain severity is at least 3 out of 10.
I have trouble sleeping for more than 30 minutes before falling asleep.
I wake up for extended periods after falling asleep for more than 3 days a week.
You may not be able to join if
I have severe underlying sleep disorders.
I am pregnant or have given birth in the past year.
I have a chronic condition that is causing other pain.
I have severe psychological or psychiatric diseases.
I have dementia or cognitive impairment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 aggrava…
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.
Trial Locations
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Eligibility 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 a…
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.
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