FibromyalgiaNCT07054333
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
A study testing Internet-delivered exposure-based cognitive behavior therapy in people with Fibromyalgia, run by Karolinska Institutet at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Internet-delivered exposure-based cognitive behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSweden
- Study dates
- 8 Jul 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Karolinska Institutet
Solna, 17177
Nobels väg 9, Neuro
Stockholm, Stockholm County, 171 77
About this study
Official title: Objektiv Mätning av Smärtreglering Hos Personer Som Erhållit Internetförmedlad Exponeringsbaserad Kognitiv Beteendeterapi
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.
Read more
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.
Read the detailed description
Design The study is a longitudinal within-group study where participants who have received internet-delivered exposure therapy for 10 weeks are examined regarding pain regulation at 3 time points: 10 weeks before treatment start (T0), directly (within 3 days) before treatment start (T1), and directly (within 1 week) after treatment (T2). Measurements regarding subjective pain, other fibromyalgia symptoms, and function are taken weekly using electronic questionnaires from T0 to T2. Disability, fatigue, avoidance behaviors, depression, and anxiety are measured at T0, T1, and T2.
Recruitment Interested individuals are requested to register via the study's web portal where the participant receives a detailed description of the study and patient information/consent. During screening, the participant answers questions about FM symptoms, medical history, and symptoms of depression and anxiety. The Fibromyalgia Survey Questionnaire is also self-administered to evaluate diagnostic criteria and establish a diagnosis. Inclusion assessment (for inclusion and exclusion criteria, see 8.3 and 8.4) is conducted by a licensed psychologist or alternatively a psychology student under the supervision of a licensed psychologist with good knowledge in psychiatric assessment and FM. An important purpose of the assessment interview is to ensure that the potential research participants understand the study's design, as well as to ensure that participants with ongoing depression do not exhibit active suicidality by having the psychologist ask questions based on the self-assessment forms that the patients have filled out previously. Individuals who meet all criteria for participation, provide informed consent and complete the baseline assessment (T-10) are can be included in the study and scheduled for visits for pain regulation assessment and treatment (see Intervention below). The primary analysis population consists of all participants who completed the pre-measurement. Participants who withdraw their consent before the baseline assessment are not included in the analysis and are reported in the CONSORT flow as 'withdrew before baseline'.
Investigation of pain regulation
The participants will make three visits to the Karolinska Institute where different aspects of pain regulation are examined. If a significant within-group effect can be observed from pre- to post-treatment on any of the outcome measures 1-5 below, a forth assessment of pain regulation will be conducted at 12 months post treatment completion. The visits are approximately 30 min long and the examination is led by a research assistant who has been trained in the measurement procedure by Associate Professor Maria Lalouni and Professor Karin Jensen, both of whom have good knowledge in experimental pain measurement and extensive experience with the patient group. Research participants who are on pain relief medication and sleep medicine as needed are asked to refrain from using these medications 48 hours before the visits. During the visits, the following aspects of pain regulation are examined:
- Pain threshold.
- Pain tolerance.
- Temporal summation (TS). Measures pain facilitation.
- Conditioned pain modulation (CPM). Measures central, descending pain modulation according to the principle "pain inhibits pain." All above tests are conducted using two computer-controlled pressure cuffs, placed on the left and right calves (Nocitech, Denmark).
- Lingering effect. Measures remaining pain (verbal report) 15 seconds after the tonic pain stimulation in the CPM test above has stopped.
Intervention The treatment lasts 10 weeks and is delivered through a secure web platform, where participants access self-help texts and illustrations. The texts provide the participant with the same knowledge as in conventional face-to-face treatment, and the treatment is based on the same strategies and exercises. Each module includes specific tasks that the participant must complete in order to progress in the treatment. Throughout the treatment, the participant has regular contact with a psychologist or a psychology student under supervision, who guides the participant through the treatment via text messages. The treatment manual is the same as that tested against waitlist control and traditional CBT in previous RCTs. The primary component is exposure to various situations, stimuli, and activities that the participant avoids in order to prevent pain and discomfort, combined with exercises in observing and describing bodily sensations without trying to change them. The purpose of the exercises is to increase the ability to remain in bodily discomfort and thereby facilitate the work with exposure.
Data analysis To evaluate the treatment's effect on self-report scales, data is analyzed using mixed effects regression models according to intent-to-treat. The investigators will use logistic regression to calculate the proportion of participants who achieve a clinically significant improvement (≥14% reduction on the primary outcome measure in symptom levels.
Differences in measures of pain regulation before and after treatment are measured using the piecewise linear mixed effects regression models. Any potential association between changes in pain threshold, pain tolerance, CPM, and temporal summation on one hand and subjectively rated symptoms and adherence on the other hand will be analyzed through correlation analysis.
- Conditions
- Fibromyalgia
- Being tested
- Internet-delivered exposure-based cognitive behavior therapy
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered exposure-based cognitive behavior therapyBehavioural
Also called Exp-CBT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Internet-delivered exposure-based cognitive behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks).
Secondary outcomes (8)
Fibromyalgia severity
The Revised Fibromyalgia Impact Questionnaire, FIQR. Self-rated, range 0-100. Higher score indicate higher FM severity.
Measured: Screening, 10 weeks before treatment start, pre-treatment, weekly up to 10 weeks.
Fatigue
Fatigue Severity Scale, FSS. Range 9-63, higher score indicate worse outcome
Measured: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks)
Pain-related avoidance behavior
Psychological inflexibility in pain - avoidance subscale, PIPS-avoid. Range 7-56, higher score indicate worse outcome.
Measured: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks)
Pain severity
Severity subscale of Brief Pain Inventory-Short form (BPI-SF). Range 0-10 where higher score indicates worse outcome.
Measured: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks)
Disability
World Health Organization disability assessment schedule 2.0, 12-item version (WHODAS 2.0). Range 0-100 where a higher score indicates worse outcome
Measured: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks).
Anxiety
State-Trait Anxiety Inventory-State, STAI-S. Range 20-80 where higher score indicates worse outcome.
Measured: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks)
Depression
Beck Depression Inventory-2, BDI-2. Range 0-63 where higher score indicates worse outcome.
Measured: 10 weeks before treatment start, pre-treatment, post-treatment
Lingering effect
Verbally reported residual pain after tonic pressure pain stimulation on the non-dominant leg has been discontinued. Measured 15 s after Conditioned Pain Modulation test has been performed.
Measured: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start8 Jul 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Hedman-Lagerlöf, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054333
- Sponsor's protocol ID
- 2025-03044-01
- Other IDs
- 2025
- Status last verified
- Nov 2026
- First submitted
- 18 Jun 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data used in this study will not be publicly available. Reasonable requests may be directed to the principal investigator and will be considered on a case-by-case basis, in accordance with the local policies of the sponsor and the relevant Swedish and European Union data protection and privacy legislation.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objektiv Mätning av Smärtreglering Hos Personer Som Erhållit Internetförmedlad Exponeringsbaserad Kognitiv Beteendeterapi
- ClinicalTrials.gov ID
- NCT07054333
- Acronym / sponsor ID
- 2025-03044-01
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Design The study is a longitudinal within-group study where participants who have received internet-delivered exposure therapy for 10 weeks are examined regarding pain regulation at 3 time points: 10 weeks before treatment start (T0), directly (within 3 days) before treatment start (T1), and directly (within 1 week) after treatment (T2). Measurements regarding subjective pain, other fibromyalgia symptoms, and function are taken weekly using electronic questionnaires from T0 to T2. Disability, fatigue, avoidance behaviors, depression, and anxiety are measured at T0, T1, and T2.
Recruitment Interested individuals are requested to register via the study's web portal where the participant receives a detailed description of the study and patient information/consent. During screening, the participant answers questions about FM symptoms, medical history, and symptoms of depression and anxiety. The Fibromyalgia Survey Questionnaire is also self-administered to evaluate diagnostic criteria and establish a diagnosis. Inclusion assessment (for inclusion and exclusion criteria, see 8.3 and 8.4) is conducted by a licensed psychologist or alternatively a psychology student under the supervision of a licensed psychologist with good knowledge in psychiatric assessment and FM. An important purpose of the assessment interview is to ensure that the potential research participants understand the study's design, as well as to ensure that participants with ongoing depression do not exhibit active suicidality by having the psychologist ask questions based on the self-assessment forms that the patients have filled out previously. Individuals who meet all criteria for participation, provide informed consent and complete the baseline assessment (T-10) are can be included in the study and scheduled for visits for pain regulation assessment and treatment (see Intervention below). The primary analysis population consists of all participants who completed the pre-measurement. Participants who withdraw their consent before the baseline assessment are not included in the analysis and are reported in the CONSORT flow as 'withdrew before baseline'.
Investigation of pain regulation
The participants will make three visits to the Karolinska Institute where different aspects of pain regulation are examined. If a significant within-group effect can be observed from pre- to post-treatment on any of the outcome measures 1-5 below, a forth assessment of pain regulation will be conducted at 12 months post treatment completion. The visits are approximately 30 min long and the examination is led by a research assistant who has been trained in the measurement procedure by Associate Professor Maria Lalouni and Professor Karin Jensen, both of whom have good knowledge in experimental pain measurement and extensive experience with the patient group. Research participants who are on pain relief medication and sleep medicine as needed are asked to refrain from using these medications 48 hours before the visits. During the visits, the following aspects of pain regulation are examined:
- Pain threshold.
- Pain tolerance.
- Temporal summation (TS). Measures pain facilitation.
- Conditioned pain modulation (CPM). Measures central, descending pain modulation according to the principle "pain inhibits pain." All above tests are conducted using two computer-controlled pressure cuffs, placed on the left and right calves (Nocitech, Denmark).
- Lingering effect. Measures remaining pain (verbal report) 15 seconds after the tonic pain stimulation in the CPM test above has stopped.
Intervention The treatment lasts 10 weeks and is delivered through a secure web platform, where participants access self-help texts and illustrations. The texts provide the participant with the same knowledge as in conventional face-to-face treatment, and the treatment is based on the same strategies and exercises. Each module includes specific tasks that the participant must complete in order to progress in the treatment. Throughout the treatment, the participant has regular contact with a psychologist or a psychology student under supervision, who guides the participant through the treatment via text messages. The treatment manual is the same as that tested against waitlist control and traditional CBT in previous RCTs. The primary component is exposure to various situations, stimuli, and activities that the participant avoids in order to prevent pain and discomfort, combined with exercises in observing and describing bodily sensations without trying to change them. The purpose of the exercises is to increase the ability to remain in bodily discomfort and thereby facilitate the work with exposure.
Data analysis To evaluate the treatment's effect on self-report scales, data is analyzed using mixed effects regression models according to intent-to-treat. The investigators will use logistic regression to calculate the proportion of participants who achieve a clinically significant improvement (≥14% reduction on the primary outcome measure in symptom levels.
Differences in measures of pain regulation before and after treatment are measured using the piecewise linear mixed effects regression models. Any potential association between changes in pain threshold, pain tolerance, CPM, and temporal summation on one hand and subjectively rated symptoms and adherence on the other hand will be analyzed through correlation analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Behavioral: Internet-delivered exposure-based cognitive behavior therapy | Experimental | Behavioral: Internet-delivered exposure-based cognitive behavior therapyInternet-delivered exposure-based cognitive behavior therapy (Exp-CBT) 10-week self-help treatment delivered via a secure online platform, with regular therapist support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-delivered exposure-based cognitive behavior therapyAlso: Exp-CBTThe 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. | Behavioural | Behavioral: Internet-delivered exposure-based cognitive behavior therapy |
Primary outcome
Conditioned pain modulation
Time frame: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks).
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.
Pain tolerance
Time frame: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks).
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.
Pain threshold
Time frame: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks).
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.
Temporal summation
Time frame: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks).
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.
8 secondary outcomes
Fibromyalgia severity
Time frame: Screening, 10 weeks before treatment start, pre-treatment, weekly up to 10 weeks.
Fatigue
Time frame: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks)
Pain-related avoidance behavior
Time frame: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks)
Pain severity
Time frame: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks)
Disability
Time frame: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks).
Anxiety
Time frame: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks)
Depression
Time frame: 10 weeks before treatment start, pre-treatment, post-treatment
Lingering effect
Time frame: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No. The data used in this study will not be publicly available. Reasonable requests may be directed to the principal investigator and will be considered on a case-by-case basis, in accordance with the local policies of the sponsor and the relevant Swedish and European Union data protection and privacy legislation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered exposure-based cognitive behavior therapy in people with Fibromyalgia, run by Karolinska Institutet at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conditioned pain modulation (time frame: 10 weeks before treatment start, pre-treatment, post-treatment (10 weeks).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.