Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT07054333
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07054333
Study Brief:
Protocol Section:
NCT07054333