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Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy

RecruitingNAAges 18 Years - anyAllKarolinska Institutet
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In plain words

What the trial is, and whether it could suit you

Fibromyalgia: a common problem that requires treatment Fibromyalgia (FM) is a highly prevalent pain syndrome characterized by generalized pain and fatigue, often leading to extensive somatic and psychological distress. The condition is associated with significant suffering and low functional capacity, and also entails high societal costs, as those affected have high levels of healthcare consumption, sick leave, and unemployment. The cause of FM is still unclear and there is no effective treatment. The most evaluated treatment is traditional cognitive behavioral therapy (CBT), which, however, appears to have only minor effects on FM. Exposure-based treatment promising Internet-based exposure-based CBT (Exp-CBT) has previously been evaluated for fibromyalgia in two randomized controlled studies. In the first study, participants (N=140) were randomised to 10 weeks of Exp-CBT or a waiting l

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Internet-delivered exposure-based cognitive behavior therapy
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Where

2 sites
Nobels väg 9, Neuro
Stockholm, Sweden
Karolinska Institutet
Solna, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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