Can online therapy rewire the Brain's pain response in fibromyalgia?

NCT ID NCT07054333

Knowledge-focused Sponsor: Karolinska Institutet Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study aims to objectively measure how internet-based exposure-based cognitive behavioral therapy (Exp-CBT) affects pain regulation in people with fibromyalgia. About 45 participants will undergo pain tests before and after 10 weeks of online therapy to see if their pain thresholds, tolerance, and pain inhibition change. The goal is to understand the mechanisms behind the treatment, not to test its effectiveness directly.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Internet-delivered exposure-based cognitive behavioral therapy (Exp-CBT)
What this could lead to: If successful, this study could reveal how online therapy changes the brain's pain processing, leading to more effective treatments for fibromyalgia.
What could go wrong: This is a small, early mechanistic study with no control group, so results may not prove cause and effect or apply to all patients. The therapy may not work for everyone.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

fibromyalgia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibromyalgia

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

2 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Can online therapy rewire the Brain's pain response in fibromyalgia?

What the study statuses mean