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

NCT07054333 | Recruiting

• 1 other identifier: 2025-03044-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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 list. The results showed that iExp had a strong effect on central FM symptoms, pain, fatigue, function and pain-related anxiety. The study also showed that iExp, compared to no treatment, is cost-effective, and that reduced FM-related avoidance behaviors drove the treatment effect. In the second study, participants (N=274) were randomized to Exp-CBT or internet-based traditional CBT (T-CBT). The results showed no significant difference between the groups after treatment. Both groups showed a marked improvement, with an average of 60% (Exp-CBT) and 59% (T-CBT) achieving a reliable change in their symptoms. People with fibromyalgia who receive exposure-based CBT thus appear to experience, on average, a reduction in symptoms and increased function. To date, studies investigating exposure-based treatment for chronic pain have used self-assessment scales to measure the effect of treatment, which is reasonable since pain is a subjective experience. However, one limitation of this is that the investigators therefore have no objective data on whether the aforementioned treatment can also lead to changes in various aspects of pain regulation, i.e., that the brain changes the way it interprets and processes pain. Objective measurement of pain regulation The present study is a longitudinal within-group study, in which the investigators intend to objectively measure various aspects of pain regulation in participants with fibromyalgia (N=45) before and after they have received internet-based exposure-based CBT. Participants undergo pain testing 10 weeks before (T0), at the start of treatment (T1), and at the end of treatment (T2), in order to measure the effect of treatment on participants' pain thresholds, pain tolerance, descending pain inhibitory function, and pain upregulation. Significant potential benefits for patients, healthcare, and society In this study, the investigators want to investigate whether the investigators can objectively see if different aspects of pain regulation are affected in participants who receive the aforementioned treatment. The study is a so-called mechanistic study, i.e., a study to understand more about how our treatment achieves its effect. Such a study makes it possible to be more precise and likely to make the treatment even more effective. The study would also contribute important knowledge to better understand the pain mechanisms in fibromyalgia, a condition with high prevalence and considered very difficult to treat.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (4)

• Conditioned pain modulation

  The degree to which pain in one area of the body is reduced when a different painful stimulus is applied elsewhere. Measured by quantitative sensory testing; a test battery with various psychophysical pain tests combined with a visual analog scale. The test is performed using two computer-controlled pressure cuffs, placed on the left and right calves, for controlled induction of pain using pressure.

  10 weeks before treatment start, pre-treatment, post-treatment (10 weeks).

• Pain tolerance

  Measured by quantitative sensory testing; a test battery with various psychophysical pain tests combined with a visual analog scale. The test is performed using two computer-controlled pressure cuffs, placed on the left and right calves, for controlled induction of pain using pressure.

  10 weeks before treatment start, pre-treatment, post-treatment (10 weeks).

• Pain threshold

  Measured by quantitative sensory testing; a test battery with various psychophysical pain tests combined with a visual analog scale. The test is performed using two computer-controlled pressure cuffs, placed on the left and right calves, for controlled induction of pain using pressure.

  10 weeks before treatment start, pre-treatment, post-treatment (10 weeks).

• Temporal summation

  The subjective pain response at repetitive pain stimulation. Measured by quantitative sensory testing; a test battery with various psychophysical pain tests combined with a visual analog scale. The test is performed using two computer-controlled pressure cuffs, placed on the left and right calves, for controlled induction of pain using pressure.

  10 weeks before treatment start, pre-treatment, post-treatment (10 weeks).

Secondary Outcomes (8)

• Fibromyalgia severity

  Screening, 10 weeks before treatment start, pre-treatment, weekly up to 10 weeks.

• Fatigue

  10 weeks before treatment start, pre-treatment, post-treatment (10 weeks)

• Pain-related avoidance behavior

  10 weeks before treatment start, pre-treatment, post-treatment (10 weeks)

• Pain severity

  10 weeks before treatment start, pre-treatment, post-treatment (10 weeks)

• Disability

  10 weeks before treatment start, pre-treatment, post-treatment (10 weeks).

Study Arms (1)

Behavioral: Internet-delivered exposure-based cognitive behavior therapy

EXPERIMENTAL

Internet-delivered exposure-based cognitive behavior therapy (Exp-CBT) 10-week self-help treatment delivered via a secure online platform, with regular therapist support.

Behavioral: Internet-delivered exposure-based cognitive behavior therapy

Interventions

Internet-delivered exposure-based cognitive behavior therapy BEHAVIORAL

The primary treatment component is exposure to stimuli (situations and activities) that give rise to pain, distress, and unwanted emotional responses. The treatment proceeds in accordance with functional analysis. Exercises are tailored for the patient so that, for example, individuals whose main coping strategy is to be overly active (i.e., persistence behavior) are encouraged to sit down and observe pain and other aversive bodily sensations as they arise. The protocol also includes regular exercises where the participant is encouraged to observe and name physical sensations without acting on them.

Also known as: Exp-CBT

Behavioral: Internet-delivered exposure-based cognitive behavior therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (2)

Nobels väg 9, Neuro

Stockholm, Stockholm County, 171 77, Sweden

RECRUITING

Karolinska Institutet

Solna, 17177, Sweden

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Maria Hedman-Lagerlöf, PhD

CONTACT

+46709348082; maria.hedman-lagerlof@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Within-group experimental study with participants acting as their own control. Participants are assessed regarding aspects of pain regulation at 10 weeks before treatment start, at treatment start (\<3 days week before treatment start), at post-treatment (within 1 week of treatment completion). If we see any significant effects on any of the outcomes another assessment is made at 12 months post-treatment completion

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: July 8, 2025
• Study Start: July 8, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)