Psychological Factors Affecting Other Medical ConditionsSOMEX2NCT07757854
Exposure Therapy for Reactivity to Symptoms
A study testing Planned, systematic, exposure exercises and Response prevention in people with Psychological Factors Affecting Other Medical Conditions and Somatic Symptom and Related Disorders, run by Region Stockholm at 1 site in Sweden.
Trial summary
It is unclear to what degree systematic exposure exercises contribute to the overall effects of exposure therapy (exposure and response prevention). This trial recruits individuals with high somatic symptom burden or reactivity to symptoms who, based on previous work, are likely to benefit specifically from exposure… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Factors Affecting Other Medical Conditions, Somatic Symptom and Related Disorders, Bodily Distress Disorder
- What is being tested?
- Planned, systematic, exposure exercises and Response prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2026to Dec 2031
- 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
- Bothered by at least one somatic symptom for at least 4 months.
- High symptom burden, defined as a PHQ-15≥15 or SSD-12≥25.
- Adult (≥18 years old).
- Living in Stockholm County (catchment area of the clinic).
- Sufficient technical knowledge with web-enabled device and fluent in Swedish.
- Complete pre-treatment assessment.
Who cannot join
- A maximum of half the sample (180 participants) will be included with health anxiety, i.e., a fear of or preoccupation with serious illness, as their principal clinical problem.
- Clinical picture dominated by non-somatoform psychiatric disorder such as depression, panic disorder, or primary insomnia. Comorbidities are allowed.
- Severe psychiatric condition (e.g., ongoing manic episode, psychotic disorder, severe depression) or markers for suicidality beyond sporadic ideation.
- Clear medical risk in taking part in exposure-based treatment (e.g., pregnancy), or somatic condition, or treatment for somatic condition, makes treatment unfeasible.
- Continuous psychotropic medication (antidepressants, anticonvulsants, mood-stabilizers, antipsychotics) is present and has either not been stable for at least 4 weeks, or is not expected to remain stable.
- Other psychotherapy or planned absence >1 week during intended main phase.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Liljeholmen University Primary Health Care Centre
Stockholm, 117 63
Erland Axelsson, PhD, +46852483930, erland.axelsson@ki.se
About this study
Official title: Randomized Controlled Dismantling Trial of Exposure Therapy for Reactivity to Symptoms
It is unclear to what degree systematic exposure exercises contribute to the overall effects of exposure therapy (exposure and response prevention). This trial recruits individuals with high somatic symptom burden or reactivity to symptoms who, based on previous work, are likely to benefit specifically from exposure therapy. The aim of the study is to evaluate to what degree the effect of exposure therapy for this group is driven by the addition of structured exposure exercises to response prevention. This will be evaluated on the basis of a randomized controlled trial (N=360) where participants are enrolled either in response prevention (n=180), or exposure and response prevention (n=180). Primary outcome will be the between-group differences in the reduction in reactivity to symptoms, as measured week-by-week using the somatic symptom disorder B-criteria scale (SSD-12). Results from this project will be informative for exposure-based and various multicomponent behavioral treatments for individuals with persistent physical symptoms worldwide.
Read the detailed description
Persistent physical symptoms refers to somatic complaints that persist for months or more and give rise to significant distress, regardless of etiology. Common complaints such as gastrointestinal symptoms, fatigue, and pain have been estimated to account for up to half of primary care consultations, can be difficult to classify, and often defy straightforward medical explanation. In light of substantial personal and socioeconomic repercussions, effective clinical interventions are needed. The investigators recently completed a randomized controlled trial in primary care (SOMEX1) where individuals with persistent physical symptoms were randomized to 10 weeks of exposure therapy or healthy lifestyle promotion. Based on that trial, exposure therapy appears to have a small average advantage over healthy lifestyle promotion in mean effect on symptom preoccupation, i.e., the patient's tendency to respond strongly to, and engage in behaviors contingent on, somatic symptoms, and also on patient satisfaction. In line with a priori hypotheses, this added effect on symptom preoccupation was larger, and an advantage in the effect on somatic symptom burden was also seen, when patients reported a very high general somatic symptom burden or symptom preoccupation before treatment. For example, a patient with a PHQ-15 score of 10 could expect a near-zero added effect of exposure therapy on somatic symptom burden (d = 0.08) and a small added effect on symptom preoccupation (d = 0.31), whereas a patient with a PHQ-15 score of 15 could expect a small to moderate added effect on somatic symptom burden (d = 0.37) and a moderate added effect on symptom preoccupation (d = 0.62). An unexpected finding, however, was that in exposure therapy, the correlation between the participant's number of exposure exercises and reduction in symptom preoccupation was weak (rs=0.21-0.26). This highlights the fact that it is yet unclear to what degree the two main components of exposure therapy - exposure and response prevention - contribute to the treatment effects. It is also unclear what patient- and contextual factors moderate the added effect of exposure.
The aim of the present project is to focus on the aforementioned subgroup of patients who benefit specifically from exposure therapy, and to determine to what degree this is driven by the addition of exposure to response prevention. This will be evaluated on the basis of a randomized controlled trial (N=360; SOMEX2) where participants with a high general somatic symptom burden or high symptom preoccupation are enrolled in response prevention (n=180), or exposure and response prevention (n=180). Primary outcome will be between-group differences in the reduction in symptom preoccupation as measured week-by-week using the somatic symptom disorder B-criteria scale (SSD-12). The participants will be blinded to the study design and the hypotheses of the investigators. Results from this project will be informative for exposure-based and various multicomponent behavioral treatments for primary care patients with persistent physical symptoms worldwide.
- Primary research question:
Is there a significant average advantage, d≥0.30, of exposure and response prevention, as compared to response prevention only, with regard to the reduction in symptom preoccupation (SSD-12) up to the post-treatment assessment? Hypothesis: Yes.
- Key secondary research questions:
Is the average advantage of adding exposure to response prevention moderated by the frequency of opportunities for response prevention as measured at baseline? Hypothesis: Yes, more opportunities are predictive of a smaller added effect of exposure exercises.
Is the average advantage of adding exposure to response prevention moderated by the temporality of unwanted outcomes as measured at baseline? Hypothesis: Yes, more distal unwanted outcomes are predictive of a larger added effect of exposure exercises.
Is the average advantage of adding exposure to response prevention moderated by anxiety sensitivity - i.e., reactivity to physiological arousal - at baseline? Hypothesis: Yes, a higher anxiety sensitivity is predictive of a larger added effect of exposure exercises.
Which additional variables act as moderators and mediators of added effects (below)?
Are there average advantages of adding exposure (superiority, ds≥0.30) with regard to general somatic symptom burden, core depressive symptoms, or functional impairment? Hypothesis: No.
What is the cost-effectiveness of exposure and response prevention versus response prevention? Exploratory analyses.
- Conditions
- Psychological Factors Affecting Other Medical Conditions, Somatic Symptom and Related Disorders, Bodily Distress Disorder
- Being tested
- Planned, systematic, exposure exercises, Response prevention
- Keywords
- exposure therapy, primary care, dismantling trial, persistent physical symptoms
- Medical subject headings
- Medically Unexplained Symptoms, Neurasthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planned, systematic, exposure exercisesBehavioural
Exposure exercises, planned on the basis of functional analysis. Participants are encouraged to evaluate the relevance of-, and if so work continuously with-, interceptive, in vivo, and imaginal exposure exercises which are planned at specific timepoints.
Response preventionBehavioural
Response prevention, planned on the basis of functional analysis. Participants make a plan to reduce presumably negatively reinforced behavior contingent on somatic symptoms and distress related to somatic symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Exposure with response prevention | Experimental | Full exposure therapy, i.e., exposure with response prevention. Receives: Behavioral: Planned, systematic, exposure exercises; Behavioral: Response prevention |
| Response prevention | Active comparator | Response prevention without conventional, planned, exposure exercises. Receives: Behavioral: Response prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Somatic Symptom Disorder-B Criteria Scale (SSD-12)
Theoretical range: 0-48. A higher score indicates higher degree of reactivity to symptoms.
Measured: Change over the main phase, as modeled using data from all 11 assessments from the baseline assessment to the primary endpoint (≤45 days after treatment). Additional analyses incorporate 6- and 12-months follow-up assessments.
Secondary outcomes (10)
Somatic Symptom Scale 8 (SSS-8)
Theoretical range: 0-32. A higher score indicates a higher subjective somatic symptom burden.
Measured: Change over the main phase, as modeled using data from all 11 assessments from the baseline assessment to the primary endpoint (≤45 days after treatment). Secondary analyses incorporate 6- and 12-months follow-up assessments.
GAD-7
Theoretical range: 0-21. A higher score indicates more general anxiety.
Measured: Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment). Additional analyses incorporate 6- and 12-months follow-up assessments.
Patient Health Questionnaire 9 (PHQ-9)
Theoretical range: 0-27. A higher score indicates more symptoms of depression.
Measured: Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment). Additional analyses incorporate 6- and 12-months follow-up assessments.
12-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Theoretical range: 0-100. A higher score indicates more disability.
Measured: Change over the main phase, as modeled using data from the baseline assessment and primary endpoint (≤45 days after treatment). Additional analyses incorporate 6- and 12-months follow-up assessments.
Seven questions probing into basic emotions related to somatic symptoms
For each emotion (anger, disgust, fear, joy, sadness, shame, surprise), theoretical range: 0-10. A higher score indicates presence of emotion.
Measured: Change over the main phase, as modeled using data from the baseline assessment and primary endpoint (≤45 days after treatment).
14-item Health Anxiety Inventory (HAI-14)
Theoretical range: 0-42. A higher score indicates more health anxiety.
Measured: Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment).
Adapted 11-item version of the Catastrophizing about Asthma Scale (CAS)
Domain-specific outcome, for participants with a mean score of at least 1 on the PHQ-15 cardiopulmonary domain. Theoretical range: 0-44. A higher score indicates more reactivity to cardiopulmonary symptoms.
Measured: Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment).
Reactivity to fatigue (study-specific)
Domain-specific outcome, for participants with a mean score of at least 1 on the PHQ-15 fatigue domain. Theoretical range: not yet finalized. A higher score indicates more reactivity to fatigue.
Measured: Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment).
Visceral Sensitivity Index (VSI)
Domain-specific outcome, for participants with a mean score of at least 1 on the PHQ-15 gastrointestinal domain. Theoretical range: 0-75. A higher score indicates reactivity to gastrointestinal symptoms
Measured: Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment).
Pain Catastrophizing Scale (PCS)
Domain-specific outcome, for participants with a mean score of at least 1 on the PHQ-15 pain domain. Theoretical range: 0-52. A higher score indicates more reactivity to pain.
Measured: Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological Factors Affecting Other Medical ConditionsStudies of the same condition, open and under way.
- More trials run by Region StockholmThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet, Stockholm University
- Responsible party
- Sponsor
- Investigators
- Erland Axelsson, PhD, Principal investigator, Region Stockholm and Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757854
- Sponsor's protocol ID
- 2026-02486-01
- Acronym
- SOMEX2
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are willing to consider reasonable requests for individual participant data (IPD) and to consult the responsible parties. However, we do not expect to be granted permission to share IPD as long as, under Swedish and European Union (EU) data protection and privacy legislation, the IPD constitutes personal data meaning that it is possible to, using the existing study database, link the IPD to an identifiable living natural person. Ten years after the last publication, the information necessary for individuals to be identified will be deleted and documentation from the trial will be archived for long-term storage. We expect to include anonymized IPD in this archive. It is our understanding that, under EU law, IPD without the existence of information necessary for individuals to be identified does not constitute personal because the IPD can no longer be linked to a living natural person. Thus, 10 years after the last publication and onwards, we expect to be able to share IPD on request.
Publications
Hybelius J, Af Winklerfelt Hammarberg S, Salomonsson S, Wachtler C, Epstein M, Olsson A, Strand E, Soderstrom Winter L, Akerlund T, Bjorkander D, Kosic A, Chahin G, Wallert J, Toth-Pal E, Nordin S, Axelsson E. Effect of internet-delivered exposure therapy versus healthy lifestyle promotion for patients with persistent physical symptoms (SOMEX1): a randomized controlled trial with planned moderator analysis. Psychol Med. 2025 Aug 8;55:e226. doi: 10.1017/S0033291725101244.
PubMed 40776412
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Dismantling Trial of Exposure Therapy for Reactivity to Symptoms
- ClinicalTrials.gov ID
- NCT07757854
- Acronym / sponsor ID
- SOMEX2 / 2026-02486-01
- Conditions
- Psychological Factors Affecting Other Medical Conditions, Somatic Symptom and Related Disorders, Bodily Distress Disorder
- Keywords
- exposure therapy, primary care, dismantling trial, persistent physical symptoms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet, Stockholm University
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 11 Aug 2026 (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.
It is unclear to what degree systematic exposure exercises contribute to the overall effects of exposure therapy (exposure and response prevention). This trial recruits individuals with high somatic symptom burden or reactivity to symptoms who, based on previous work, are likely to benefit specifically from exposure therapy. The aim of the study is to evaluate to what degree the effect of exposure therapy for this group is driven by the addition of structured exposure exercises to response prevention. This will be evaluated on the basis of a randomized controlled trial (N=360) where participants are enrolled either in response prevention (n=180), or exposure and response prevention (n=180). Primary outcome will be the between-group differences in the reduction in reactivity to symptoms, as measured week-by-week using the somatic symptom disorder B-criteria scale (SSD-12). Results from this project will be informative for exposure-based and various multicomponent behavioral treatments for individuals with persistent physical symptoms worldwide.
Detailed description
Persistent physical symptoms refers to somatic complaints that persist for months or more and give rise to significant distress, regardless of etiology. Common complaints such as gastrointestinal symptoms, fatigue, and pain have been estimated to account for up to half of primary care consultations, can be difficult to classify, and often defy straightforward medical explanation. In light of substantial personal and socioeconomic repercussions, effective clinical interventions are needed. The investigators recently completed a randomized controlled trial in primary care (SOMEX1) where individuals with persistent physical symptoms were randomized to 10 weeks of exposure therapy or healthy lifestyle promotion. Based on that trial, exposure therapy appears to have a small average advantage over healthy lifestyle promotion in mean effect on symptom preoccupation, i.e., the patient's tendency to respond strongly to, and engage in behaviors contingent on, somatic symptoms, and also on patient satisfaction. In line with a priori hypotheses, this added effect on symptom preoccupation was larger, and an advantage in the effect on somatic symptom burden was also seen, when patients reported a very high general somatic symptom burden or symptom preoccupation before treatment. For example, a patient with a PHQ-15 score of 10 could expect a near-zero added effect of exposure therapy on somatic symptom burden (d = 0.08) and a small added effect on symptom preoccupation (d = 0.31), whereas a patient with a PHQ-15 score of 15 could expect a small to moderate added effect on somatic symptom burden (d = 0.37) and a moderate added effect on symptom preoccupation (d = 0.62). An unexpected finding, however, was that in exposure therapy, the correlation between the participant's number of exposure exercises and reduction in symptom preoccupation was weak (rs=0.21-0.26). This highlights the fact that it is yet unclear to what degree the two main components of exposure therapy - exposure and response prevention - contribute to the treatment effects. It is also unclear what patient- and contextual factors moderate the added effect of exposure.
The aim of the present project is to focus on the aforementioned subgroup of patients who benefit specifically from exposure therapy, and to determine to what degree this is driven by the addition of exposure to response prevention. This will be evaluated on the basis of a randomized controlled trial (N=360; SOMEX2) where participants with a high general somatic symptom burden or high symptom preoccupation are enrolled in response prevention (n=180), or exposure and response prevention (n=180). Primary outcome will be between-group differences in the reduction in symptom preoccupation as measured week-by-week using the somatic symptom disorder B-criteria scale (SSD-12). The participants will be blinded to the study design and the hypotheses of the investigators. Results from this project will be informative for exposure-based and various multicomponent behavioral treatments for primary care patients with persistent physical symptoms worldwide.
- Primary research question:
Is there a significant average advantage, d≥0.30, of exposure and response prevention, as compared to response prevention only, with regard to the reduction in symptom preoccupation (SSD-12) up to the post-treatment assessment? Hypothesis: Yes.
- Key secondary research questions:
Is the average advantage of adding exposure to response prevention moderated by the frequency of opportunities for response prevention as measured at baseline? Hypothesis: Yes, more opportunities are predictive of a smaller added effect of exposure exercises.
Is the average advantage of adding exposure to response prevention moderated by the temporality of unwanted outcomes as measured at baseline? Hypothesis: Yes, more distal unwanted outcomes are predictive of a larger added effect of exposure exercises.
Is the average advantage of adding exposure to response prevention moderated by anxiety sensitivity - i.e., reactivity to physiological arousal - at baseline? Hypothesis: Yes, a higher anxiety sensitivity is predictive of a larger added effect of exposure exercises.
Which additional variables act as moderators and mediators of added effects (below)?
Are there average advantages of adding exposure (superiority, ds≥0.30) with regard to general somatic symptom burden, core depressive symptoms, or functional impairment? Hypothesis: No.
What is the cost-effectiveness of exposure and response prevention versus response prevention? Exploratory analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure with response prevention | Experimental | Behavioral: Planned, systematic, exposure exercises, Behavioral: Response preventionFull exposure therapy, i.e., exposure with response prevention. |
| Response prevention | Active comparator | Behavioral: Response preventionResponse prevention without conventional, planned, exposure exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Bothered by at least one somatic symptom for at least 4 months.
- High symptom burden, defined as a PHQ-15≥15 or SSD-12≥25.
- Adult (≥18 years old).
- Living in Stockholm County (catchment area of the clinic).
- Sufficient technical knowledge with web-enabled device and fluent in Swedish.
Key exclusion criteria (6 listed)
- A maximum of half the sample (180 participants) will be included with health anxiety, i.e., a fear of or preoccupation with serious illness, as their principal clinical problem.
- Clinical picture dominated by non-somatoform psychiatric disorder such as depression, panic disorder, or primary insomnia. Comorbidities are allowed.
- Severe psychiatric condition (e.g., ongoing manic episode, psychotic disorder, severe depression) or markers for suicidality beyond sporadic ideation.
- Clear medical risk in taking part in exposure-based treatment (e.g., pregnancy), or somatic condition, or treatment for somatic condition, makes treatment unfeasible.
- Continuous psychotropic medication (antidepressants, anticonvulsants, mood-stabilizers, antipsychotics) is present and has either not been stable for at least 4 weeks, or is not expected to remain stable.
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 |
|---|---|---|
| Planned, systematic, exposure exercisesExposure exercises, planned on the basis of functional analysis. Participants are encouraged to evaluate the relevance of-, and if so work continuously with-, interceptive, in vivo, and imaginal exposure exercises which are planned at specific timepoints. | Behavioural | Exposure with response prevention |
| Response preventionResponse prevention, planned on the basis of functional analysis. Participants make a plan to reduce presumably negatively reinforced behavior contingent on somatic symptoms and distress related to somatic symptoms. | Behavioural | Exposure with response prevention, Response prevention |
Primary outcome
Somatic Symptom Disorder-B Criteria Scale (SSD-12)
Time frame: Change over the main phase, as modeled using data from all 11 assessments from the baseline assessment to the primary endpoint (≤45 days after treatment). Additional analyses incorporate 6- and 12-months follow-up assessments.
Theoretical range: 0-48. A higher score indicates higher degree of reactivity to symptoms.
10 secondary outcomes
Somatic Symptom Scale 8 (SSS-8)
Time frame: Change over the main phase, as modeled using data from all 11 assessments from the baseline assessment to the primary endpoint (≤45 days after treatment). Secondary analyses incorporate 6- and 12-months follow-up assessments.
GAD-7
Time frame: Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment). Additional analyses incorporate 6- and 12-months follow-up assessments.
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment). Additional analyses incorporate 6- and 12-months follow-up assessments.
12-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: Change over the main phase, as modeled using data from the baseline assessment and primary endpoint (≤45 days after treatment). Additional analyses incorporate 6- and 12-months follow-up assessments.
Seven questions probing into basic emotions related to somatic symptoms
Time frame: Change over the main phase, as modeled using data from the baseline assessment and primary endpoint (≤45 days after treatment).
14-item Health Anxiety Inventory (HAI-14)
Time frame: Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment).
Adapted 11-item version of the Catastrophizing about Asthma Scale (CAS)
Time frame: Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment).
Reactivity to fatigue (study-specific)
Time frame: Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment).
Visceral Sensitivity Index (VSI)
Time frame: Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment).
Pain Catastrophizing Scale (PCS)
Time frame: Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment).
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 11 Aug 2026.
- Background: PubMed 40776412Hybelius J, Af Winklerfelt Hammarberg S, Salomonsson S, Wachtler C, Epstein M, Olsson A, Strand E, Soderstrom Winter L, Akerlund T, Bjorkander D, Kosic A, Chahin G, Wallert J, Toth-Pal E, Nordin S, Axelsson E. Effect of internet-delivered exposure therapy versus healthy lifestyle promotion for patients with persistent physical symptoms (SOMEX1): a randomized controlled trial with planned moderator analysis. Psychol Med. 2025 Aug 8;55:e226. doi: 10.1017/S0033291725101244.
- Individual participant dataSharing planned: No. We are willing to consider reasonable requests for individual participant data (IPD) and to consult the responsible parties. However, we do not expect to be granted permission to share IPD as long as, under Swedish and European Union (EU) data protection and privacy legislation, the IPD constitutes personal data meaning that it is possible to, using the existing study database, link the IPD to an identifiable living natural person. Ten years after the last publication, the information necessary for individuals to be identified will be deleted and documentation from the trial will be archived for long-term storage. We expect to include anonymized IPD in this archive. It is our understanding that, under EU law, IPD without the existence of information necessary for individuals to be identified does not constitute personal because the IPD can no longer be linked to a living natural person. Thus, 10 years after the last publication and onwards, we expect to be able to share IPD on request.
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.
Erland Axelsson, PhD principal investigator
Region Stockholm and Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Planned, systematic, exposure exercises and Response prevention in people with Psychological Factors Affecting Other Medical Conditions and Somatic Symptom and Related Disorders, run by Region Stockholm at 1 site 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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Erland Axelsson, PhD (+46852483930, erland.axelsson@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Somatic Symptom Disorder-B Criteria Scale (SSD-12) (time frame: Change over the main phase, as modeled using data from all 11 assessments from the baseline assessment to the primary endpoint (≤45 days after treatment). Additional analyses incorporate 6- and 12-months follow-up assessments.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07757854, which also lists 1 linked publication.
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 11 Aug 2026.