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

Launched by KAROLINSKA INSTITUTET · Jun 26, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to measure how internet-based exposure therapy affects pain in people with fibromyalgia, a condition that causes widespread pain and tiredness. While previous studies have shown that this type of online therapy can help reduce symptoms and improve daily functioning, this trial aims to see if the treatment actually changes how the brain processes pain. To do this, participants will take part in several pain tests before, during, and after the 10-week therapy program to track changes in pain sensitivity and pain control.

Adults diagnosed with fibromyalgia who live in Sweden and have internet access may be eligible to join. Participants should not have severe depression, certain other mental health conditions, or be using opioids, and they must be willing to avoid other psychological treatments during the study. Those who join will complete pain tests in person at the Karolinska Institutet on a few occasions and take part in the full 10-week online therapy. This study could help improve fibromyalgia treatment by better understanding how exposure therapy works in the brain, potentially leading to more effective care in the future.

Gender

ALL

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 and residing in Sweden
• • 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:
• • Depression or anxiety requiring treatment, 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 or a self-reported diagnosis of bipolar disorder, PTSD, or exhaustion syndrome
• • 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)
• • 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.