Measuring changes in pain regulation after online exposure-based CBT for fibromyalgia
Objektiv Mätning av Smärtreglering Hos Personer Som Erhållit Internetförmedlad Exponeringsbaserad Kognitiv Beteendeterapi
This study tests whether a 10-week internet-delivered exposure-based cognitive behavioral therapy changes objective pain regulation in adults with fibromyalgia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 2 sites (Stockholm, Stockholm County and 1 other locations) |
| Trial ID | NCT07054333 on ClinicalTrials.gov |
What this trial studies
This is a longitudinal within-group study of adults with fibromyalgia who complete 10 weeks of internet-delivered exposure-based CBT, with objective pain regulation measured at three time points: about 10 weeks before treatment, within three days before treatment start, and within one week after treatment end. Participants complete weekly electronic questionnaires about pain, fibromyalgia symptoms, and function from baseline to post-treatment, and additional measures of disability, fatigue, avoidance, depression, and anxiety at the three main time points. A licensed psychologist (or supervised trainee) conducts clinical screening and confirms fibromyalgia criteria before inclusion, and participants attend Karolinska Institutet for 3–4 in-person pain tests.
Who should consider this trial
Good fit: Adults (≥18) with a physician-diagnosed fibromyalgia confirmed by the Fibromyalgia Survey Questionnaire, living in Sweden or Finland, with internet access, stable relevant medications, and willingness to attend in-person pain testing and avoid other psychological treatment during the study.
Not a fit: Patients with severe, untreated depressive or anxiety disorders, PTSD, exhaustion syndrome, unstable or unmedicated bipolar disorder, or those unable to attend in-person testing or who live outside Sweden/Finland are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could show that online exposure-based CBT produces measurable improvements in pain regulation and symptoms, supporting broader use of this accessible treatment.
How similar studies have performed: Previous randomized studies of internet-delivered exposure-based CBT for fibromyalgia have reported strong effects on core symptoms, so this protocol builds on promising prior results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥18 years of age * Diagnosed with fibromyalgia (indicated by a diagnosis from a physician and confirmed by the Fibromyalgia Survey Questionnaire during the assessment interview) * Access to the internet * Willing to refrain from other psychological treatment during the study, * Registered with Swedish personal ID number and residing in Sweden or Finland * If taking antidepressant or antiepileptic medication, this must be stable for 4 weeks prior to baseline measurement, * Willing to come to Karolinska Institutet and participate in pain tests on 3-4 occasions, and * Gives informed consent Exclusion Criteria: * Treatment-requiring depressive- or anxiety disorder, eating disorder or stress-related ill health, indicated by a score of ≥35 on the Montgomery-Åsberg Depression Rating Scale-Self-Rated (MADRS-S) and confirmed in a clinical assessment interview as severe depression; ongoing diagnosis of PTSD or exhaustion syndrome, unstable or unmedicated bipolar syndrome, severe obsessive-compulsive disorder or eating disorder * Active suicidality, indicated by ≥4 on item 9 of the MADRS-S and confirmed in a clinical assessment interview * Psychotic illness * Late pregnancy (≥29 weeks at treatment start) * Other somatic conditions requiring immediate treatment and/or assessed as the participant's primary problem, including other dominant pain problems and chronic fatigue syndrome (ME/CFS) * Ongoing alcohol or substance abuse * Opioid use * Insufficient knowledge of Swedish or computer use to benefit from text-based treatment.
Where this trial is running
Stockholm, Stockholm County and 1 other locations
- Nobels väg 9, Neuro — Stockholm, Stockholm County, Sweden (Recruiting)
- Karolinska Institutet — Solna, Sweden (Recruiting)
Study contacts
- Study coordinator: Maria Hedman-Lagerlöf, PhD
- Email: maria.hedman-lagerlof@ki.se
- Phone: +46709348082
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.