Recruiting NA Fibromyalgia

New treatment option for Fibromyalgia

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

ClinicalTrials.gov ID: NCT07054333

What this study is testing

What it's testing
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.
  • Time commitment: about 10 weeks
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • ≥18 years of age
  • Diagnosed with fibromyalgia (indicated by a diagnosis from a physician and confirmed by the Fibromyalgia Survey Questionnaire during the assessment...
  • 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

You likely can't join if

  • Treatment-requiring depressive- or anxiety disorder, eating disorder or stress-related ill health, indicated by a score of ≥35 on the...
  • 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...
  • Ongoing alcohol or substance abuse
See the full eligibility criteria
Who can join
  • ≥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
What rules you out
  • 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...
  • 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Stockholm, Stockholm County, Sweden
  • Solna, Sweden

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The study runs about 10 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Stockholm, Stockholm County, Sweden; Solna, Sweden. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.