Somatic Symptom and Related DisordersSOMEX1NCT04942028
Exposure Therapy vs. Standardized Education for Distress Related to Somatic Symptoms
A study testing Exposure, Standardized education and Prolonged assessment in people with Somatic Symptom and Related Disorders and Medically Unexplained Symptoms, run by Region Stockholm at 1 site in Sweden.
Trial summary
The annual societal cost of medically unexplained symptoms in Sweden is approximately 40 billion SEK, i.e., similar to the annual cost of cancer. Prevalent chronic diseases like asthma and diabetes are also commonly associated with somatic symptoms that lead to significant distress and pervasive behavioral changes… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Somatic Symptom and Related Disorders, Medically Unexplained Symptoms, Psychological Factors Affecting Other Medical Conditions
- What is being tested?
- Exposure, Standardized education and Prolonged assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteSweden
- Study dates
- 7 Oct 2021to 2 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- (i) Either much bothered by at least one somatic symptom (2 points on at least one item of the PHQ-15) or at least a moderate overall somatic symptom burden (PHQ-15 sum ≥10), with (ii) recurrent distress related to somatic symptoms ≥4 months
- Interested in completing an intense psychological treatment with the aim of reducing distress associated with physical symptoms
- Adult (≥18 years old)
- Living in Stockholm County
- Can read and write in Swedish
- Complete baseline assessment
Who cannot join
- Symptoms best explained by, or clinical picture dominated by, severe health anxiety or a non-somatoform psychiatric disorder such as depression, panic disorder, primary insomnia, a chronic stress disorder, or an acute stress disorder
- Severe psychiatric condition or suicidal ideation
- Clear medical risk in taking part in exposure-based treatment (e.g., pregnancy) or somatic condition (e.g., recent cancer diagnosis), or treatment for somatic condition (e.g., recent chemotherapy), makes treatment unfeasible
- Continuous psychotropic medication (antidepressants, anticonvulsants, mood-stabilizers, antipsychotics) not stable in past 4 weeks, or not expected to remain stable over the main phase of the trial
- Severe alcohol or substance use disorder likely to interfere with treatment
- Planned absence for more than 1 week during the intended main phase
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Liljeholmen University Primary Health Care Centre
Stockholm, 11763
About this study
Official title: Randomized Controlled Trial of Internet-delivered Exposure-based Treatment vs. Standardized Education for Distress Related to Somatic Symptoms in Primary Care
The annual societal cost of medically unexplained symptoms in Sweden is approximately 40 billion SEK, i.e., similar to the annual cost of cancer. Prevalent chronic diseases like asthma and diabetes are also commonly associated with somatic symptoms that lead to significant distress and pervasive behavioral changes that result in functional impairment and place added strain on the health care system. Exposure-based treatment, where the patient willingly engages with stimuli that give rise to unwanted physical sensations or distress, has shown promise in reducing somatic symptom load and increasing quality of life in several conditions where patients commonly report substantial distress related to somatic symptoms, such as in asthma, musculoskeletal pain, and functional gastrointestinal syndromes. In routine care, however, access to such exposure-based treatment is limited. One reason for this is probably that there exists no flexible exposure-based treatment protocol that can be easily tailored to suit a wide spectrum of patient groups who suffer from distress related to recurrent somatic symptoms. In a recent single group feasibility trial (N=33) at Karolinska Institutet, Sweden, the investigators found that such a tailored exposure-based treatment delivered in an online text-based format can be acceptable, with high treatment adherence, adequate treatment satisfaction, large and lasting within-group improvement, and no serious adverse events. This is a randomized controlled trial (N=160) where the investigators aim to test if the same tailored internet-delivered exposure-based treatment is more efficacious than a standardized education control for adult patients with clinically significant distress related to somatic symptoms in a primary care setting. Primary outcome is change in self-rated somatic symptom burden as modelled using linear mixed models fitted on weekly Patient Health Questionnaire 15 sum scores over the treatment period. Long-term efficacy is assessed up to one year after treatment and cost-effectiveness is investigated based on the incremental cost-effectiveness ratio.
Read the detailed description
Approximately one fifth of primary care patients seek care for symptoms that cannot readily be given a medical explanation. In addition, primary care is tasked with offering care for prevalent chronic diseases such as asthma and diabetes where somatic symptoms often lead to distress and pervasive behavioral changes. Though a concern with somatic symptoms can be fully warranted, helpful, and transient, it can also be persistent and lead to much unnecessary suffering. Existing treatments commonly yield insufficient effects on medically unexplained symptoms.
Psychological factors - in particular the preoccupation with symptoms - have been found to affect the perception and intensity of a large number of physical symptoms, both with and without a clear medical genesis. In pain, it has for example been found that fear and the preoccupation with symptoms can have a more substantial predictive value for chronicity than pain itself. In general, in individuals who suffer from clinically significant symptom preoccupation, behaviors intended to evaluate symptoms, seek information about symptoms, or avoid discomfort have been found to often contribute to worsened function and increased symptom burden in the long term.
This makes exposure, where the patient willingly and systematically approaches stimuli that give rise to unwanted symptoms or discomfort while refraining from acting on symptoms, a logical intervention. There are several examples where exposure-based treatment has been found to be efficacious when protocols were written to suit a particular group of patients where distress associated with somatic symptoms is common, e.g., a particular functional somatic syndrome in terms of fibromyalgia and irritable bowel syndrome, or a chronic somatic condition such as asthma or atrial fibrillation. Typically, effects on symptoms and the preoccupation with symptoms have been large, and there is evidence to suggests that a reduction in somatic symptom burden may have been mediated by a reduction in symptom preoccupation or behaviors that serve to reduce distress in the short term.
Generalist primary care clinics typically do not have the resources necessary for administering specific psychological treatments for a large number specific functional somatic syndromes or chronic somatic conditions. The investigators suspect that a more general treatment protocol that can be tailored to suit a wide spectrum of physical symptoms could dramatically improve access to exposure-based treatment for patients with distress related to somatic symptoms. This may be particularly true if treatment can be delivered via the internet, which requires less therapist time but often results in similar effects as face-to-face treatment.
The investigators recently completed a feasibility trial at Karolinska Institutet, Sweden (NCT04511286), where the investigators found that an internet-delivered flexible exposure-based treatment for individuals with high levels of symptom preoccupation regardless of somatic symptom domain (N=33; e.g., functional gastrointestinal symptoms, atrial fibrillation, migraine) can be delivered with high treatment adherence, adequate client satisfaction, large and lasting improvement in self-reported somatic symptoms and symptom preoccupation, and no serious adverse events. It is thus motivated to evaluate this treatment format further.
In further evaluating the flexible exposure-based treatment approach for patients with distress related to somatic symptoms it is imperative to conduct a randomized controlled trial versus an informative control condition, focusing on effects on somatic symptoms and symptom preoccupation. It is also important to evaluate if the treatment can be effective in a routine clinical setting and when patients are referred via a clinician such as a general practitioner. In this trial, the investigators aim to evaluate if flexible internet-delivered exposure-based treatment is more effective than an internet-delivered standardized routine care education program for patients with distress related to somatic symptoms in primary care.
- Primary research question:
Compared to the control condition, does flexible internet-delivered exposure-based treatment lead to a larger average improvement in self-rated somatic symptom burden as assessed using the Patient Health Questionnaire 15 (PHQ-15)? Hypothesis: Yes.
- Key secondary research questions:
Compared to the control condition, does flexible internet-delivered exposure-based treatment lead to a larger average improvement in symptom preoccupation, psychiatric symptom burden, and functional impairment? Hypothesis: Yes.
In flexible internet-delivered exposure-based treatment, are effects typically maintained up to 12 months after treatment? Hypothesis: Yes.
Is flexible internet-delivered exposure-based treatment cost-effective compared to the control condition? Hypothesis: Yes.
Is the controlled effect of the flexible exposure-based treatment on self-rated somatic symptoms moderated by baseline symptoms and preoccupation? Hypothesis: Yes.
Is the effect of the flexible exposure-based treatment on self-rated somatic symptom burden mediated by a reduction in symptom preoccupation? Hypothesis: Yes.
- Conditions
- Somatic Symptom and Related Disorders, Medically Unexplained Symptoms, Psychological Factors Affecting Other Medical Conditions
- Being tested
- Exposure, Standardized education, Prolonged assessment
- Keywords
- exposure, primary care
- Medical subject headings
- Medically Unexplained Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExposureBehavioural
Systematic confrontation with stimuli associated with symptom-related distress, to achieve therapeutic changes in cognitions or behavior
Standardized educationBehavioural
Standardized routine care education for individuals suffering from distress related to somatic symptoms, primarily focusing on healthy lifestyle behaviors such as sleep, diet, and exercise
Prolonged assessmentBehavioural
Patients are encouraged to keep a rudimentary symptom diary to track if and how their symptoms interact with mood and lifestyle behaviors
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered exposure-based treatment | Experimental | 10 weeks of therapist-guided exposure-based treatment delivered via the Internet. Receives: Behavioral: Exposure |
| Internet-delivered standardized education and prolonged assessment | Active comparator | 10 weeks of therapist-guided intervention based on prolonged assessment and routine care educational material delivered via the Internet. Receives: Behavioral: Standardized education; Behavioral: Prolonged assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-15 (PHQ-15)
Theoretical range: 0-30. A higher score indicates a higher subjective somatic symptom burden.
Measured: Change over the main phase, as modelled 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.
Secondary outcomes (15)
Somatic Symptom Disorder-B Criteria Scale (SSD-12)
Theoretical range: 0-48. A higher score indicates higher degree of preoccupation with symptoms.
Measured: Change over the main phase, as modelled 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.
Symptom Preoccupation Scale (preliminary scale)
Under development. A higher score indicates higher degree of preoccupation with symptoms.
Measured: Change over the main phase, as modelled 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.
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 (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 modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment). Additional analyses incorporate 6- and 12-months follow-up assessments.
14-item Health Anxiety Inventory (HAI-14)
Theoretical range: 0-42. A higher score indicates more health anxiety.
Measured: Screening only
Alcohol Use Disorders Identification Test (AUDIT)
Theoretical range: 0-40. A higher score indicates more problematic alcohol use.
Measured: Screening only
Drug Use Disorders Identification Test (DUDIT)
Theoretical range: 0-44. A higher score indicates more problematic substance use.
Measured: Screening only
Credibility/Expectancy scale (C/E scale)
Theoretical range: 0-50. A higher score indicates higher credibility/expectancy.
Measured: Week 3 of main phase
Working Alliance Inventory (WAI)
Theoretical range: 6-42. A higher score indicates better relationship with the therapist.
Measured: Week 3 of main phase
Client Satisfaction Questionnaire (CSQ-8)
Theoretical range: 8-32. A higher score indicates higher satisfaction with treatment.
Measured: Primary endpoint assessment (≤45 days after treatment)
EuroQol 5D (EQ-5D)
Theoretical range: 0-1, i.e., scored as utility for the purpose of calculating quality-adjusted life years for health economic analysis. A higher utility score indicates a higher health-related quality of life.
Measured: Data from the baseline assessment, the primary endpoint, and the 6- and 12-month follow-up are used for health economic analysis focusing on the main phase.
Trimbos Institute and Institute of Medical Technology Questionnaire for Costs Associated with Psychiatric Illness (TIC-P)
This instrument is scored in terms of resource use for the purpose of calculating societal costs for health economic analysis.
Measured: Data from the baseline assessment, the primary endpoint, and the 6- and 12-month follow-up are used for health economic analysis focusing on the main phase.
Four questions corresponding to presumed components of subjective somatic symptom burden
These questions concern (1) somatic symptom severity, (2) somatic symptom frequency/duration, (3) distress related to somatic symptoms, and (4) the impact of somatic symptoms on disability. Answers are given on visual analogue scales.
Measured: Measured at screening, baseline assessment, and the primary endpoint
Seven questions probing into basic emotions related to somatic symptoms
Answers are given on visual analogue scales.
Measured: Measured at screening, baseline assessment, and the primary endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start7 Oct 2021
- Primary completion2 Jan 2025
- Study completion2 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Somatic Symptom and Related DisordersStudies 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
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Erland Axelsson, PhD, Principal investigator, Region Stockholm and Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942028
- Sponsor's protocol ID
- 2021-01400
- Acronym
- SOMEX1
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2021
- Last updated
- 23 Jun 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 40776412Hybelius J, Af Winklerfelt Hammarberg S, Salomonsson S, Wachtler C, Epstein M, Olsson A, Strand E, Soderstrom Winter L, Ahnlund Hoffmann A, Spansk E, Akerlund T, Bjorkander D, Kosic A, Chahin G, Wallert J, Toth-Pal E, Nordin S, Witthoft M, Axelsson E. Basic emotions reported by individuals with persistent physical symptoms receiving exposure therapy versus healthy lifestyle promotion in primary care. Sci Rep. 2026 Feb 17;16(1):7170. doi: 10.1038/s41598-026-39962-x.
PubMed 41702998
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Internet-delivered Exposure-based Treatment vs. Standardized Education for Distress Related to Somatic Symptoms in Primary Care
- ClinicalTrials.gov ID
- NCT04942028
- Acronym / sponsor ID
- SOMEX1 / 2021-01400
- Conditions
- Somatic Symptom and Related Disorders, Medically Unexplained Symptoms, Psychological Factors Affecting Other Medical Conditions
- Keywords
- exposure, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 2 Jan 2025 (actual)
- Study completion
- 2 Jan 2025 (actual)
- First posted
- 28 Jun 2021 (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.
The annual societal cost of medically unexplained symptoms in Sweden is approximately 40 billion SEK, i.e., similar to the annual cost of cancer. Prevalent chronic diseases like asthma and diabetes are also commonly associated with somatic symptoms that lead to significant distress and pervasive behavioral changes that result in functional impairment and place added strain on the health care system. Exposure-based treatment, where the patient willingly engages with stimuli that give rise to unwanted physical sensations or distress, has shown promise in reducing somatic symptom load and increasing quality of life in several conditions where patients commonly report substantial distress related to somatic symptoms, such as in asthma, musculoskeletal pain, and functional gastrointestinal syndromes. In routine care, however, access to such exposure-based treatment is limited. One reason for this is probably that there exists no flexible exposure-based treatment protocol that can be easily tailored to suit a wide spectrum of patient groups who suffer from distress related to recurrent somatic symptoms. In a recent single group feasibility trial (N=33) at Karolinska Institutet, Sweden, the investigators found that such a tailored exposure-based treatment delivered in an online text-based format can be acceptable, with high treatment adherence, adequate treatment satisfaction, large and lasting within-group improvement, and no serious adverse events. This is a randomized controlled trial (N=160) where the investigators aim to test if the same tailored internet-delivered exposure-based treatment is more efficacious than a standardized education control for adult patients with clinically significant distress related to somatic symptoms in a primary care setting. Primary outcome is change in self-rated somatic symptom burden as modelled using linear mixed models fitted on weekly Patient Health Questionnaire 15 sum scores over the treatment period. Long-term efficacy is assessed up to one year after treatment and cost-effectiveness is investigated based on the incremental cost-effectiveness ratio.
Detailed description
Approximately one fifth of primary care patients seek care for symptoms that cannot readily be given a medical explanation. In addition, primary care is tasked with offering care for prevalent chronic diseases such as asthma and diabetes where somatic symptoms often lead to distress and pervasive behavioral changes. Though a concern with somatic symptoms can be fully warranted, helpful, and transient, it can also be persistent and lead to much unnecessary suffering. Existing treatments commonly yield insufficient effects on medically unexplained symptoms.
Psychological factors - in particular the preoccupation with symptoms - have been found to affect the perception and intensity of a large number of physical symptoms, both with and without a clear medical genesis. In pain, it has for example been found that fear and the preoccupation with symptoms can have a more substantial predictive value for chronicity than pain itself. In general, in individuals who suffer from clinically significant symptom preoccupation, behaviors intended to evaluate symptoms, seek information about symptoms, or avoid discomfort have been found to often contribute to worsened function and increased symptom burden in the long term.
This makes exposure, where the patient willingly and systematically approaches stimuli that give rise to unwanted symptoms or discomfort while refraining from acting on symptoms, a logical intervention. There are several examples where exposure-based treatment has been found to be efficacious when protocols were written to suit a particular group of patients where distress associated with somatic symptoms is common, e.g., a particular functional somatic syndrome in terms of fibromyalgia and irritable bowel syndrome, or a chronic somatic condition such as asthma or atrial fibrillation. Typically, effects on symptoms and the preoccupation with symptoms have been large, and there is evidence to suggests that a reduction in somatic symptom burden may have been mediated by a reduction in symptom preoccupation or behaviors that serve to reduce distress in the short term.
Generalist primary care clinics typically do not have the resources necessary for administering specific psychological treatments for a large number specific functional somatic syndromes or chronic somatic conditions. The investigators suspect that a more general treatment protocol that can be tailored to suit a wide spectrum of physical symptoms could dramatically improve access to exposure-based treatment for patients with distress related to somatic symptoms. This may be particularly true if treatment can be delivered via the internet, which requires less therapist time but often results in similar effects as face-to-face treatment.
The investigators recently completed a feasibility trial at Karolinska Institutet, Sweden (NCT04511286), where the investigators found that an internet-delivered flexible exposure-based treatment for individuals with high levels of symptom preoccupation regardless of somatic symptom domain (N=33; e.g., functional gastrointestinal symptoms, atrial fibrillation, migraine) can be delivered with high treatment adherence, adequate client satisfaction, large and lasting improvement in self-reported somatic symptoms and symptom preoccupation, and no serious adverse events. It is thus motivated to evaluate this treatment format further.
In further evaluating the flexible exposure-based treatment approach for patients with distress related to somatic symptoms it is imperative to conduct a randomized controlled trial versus an informative control condition, focusing on effects on somatic symptoms and symptom preoccupation. It is also important to evaluate if the treatment can be effective in a routine clinical setting and when patients are referred via a clinician such as a general practitioner. In this trial, the investigators aim to evaluate if flexible internet-delivered exposure-based treatment is more effective than an internet-delivered standardized routine care education program for patients with distress related to somatic symptoms in primary care.
- Primary research question:
Compared to the control condition, does flexible internet-delivered exposure-based treatment lead to a larger average improvement in self-rated somatic symptom burden as assessed using the Patient Health Questionnaire 15 (PHQ-15)? Hypothesis: Yes.
- Key secondary research questions:
Compared to the control condition, does flexible internet-delivered exposure-based treatment lead to a larger average improvement in symptom preoccupation, psychiatric symptom burden, and functional impairment? Hypothesis: Yes.
In flexible internet-delivered exposure-based treatment, are effects typically maintained up to 12 months after treatment? Hypothesis: Yes.
Is flexible internet-delivered exposure-based treatment cost-effective compared to the control condition? Hypothesis: Yes.
Is the controlled effect of the flexible exposure-based treatment on self-rated somatic symptoms moderated by baseline symptoms and preoccupation? Hypothesis: Yes.
Is the effect of the flexible exposure-based treatment on self-rated somatic symptom burden mediated by a reduction in symptom preoccupation? Hypothesis: Yes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered exposure-based treatment | Experimental | Behavioral: Exposure10 weeks of therapist-guided exposure-based treatment delivered via the Internet. |
| Internet-delivered standardized education and prolonged assessment | Active comparator | Behavioral: Standardized education, Behavioral: Prolonged assessment10 weeks of therapist-guided intervention based on prolonged assessment and routine care educational material delivered via the Internet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- (i) Either much bothered by at least one somatic symptom (2 points on at least one item of the PHQ-15) or at least a moderate overall somatic symptom burden (PHQ-15 sum ≥10), with (ii) recurrent distress related to somatic symptoms ≥4 months
- Interested in completing an intense psychological treatment with the aim of reducing distress associated with physical symptoms
- Adult (≥18 years old)
- Living in Stockholm County
- Can read and write in Swedish
Key exclusion criteria (6 listed)
- Symptoms best explained by, or clinical picture dominated by, severe health anxiety or a non-somatoform psychiatric disorder such as depression, panic disorder, primary insomnia, a chronic stress disorder, or an acute stress disorder
- Severe psychiatric condition or suicidal ideation
- Clear medical risk in taking part in exposure-based treatment (e.g., pregnancy) or somatic condition (e.g., recent cancer diagnosis), or treatment for somatic condition (e.g., recent chemotherapy), makes treatment unfeasible
- Continuous psychotropic medication (antidepressants, anticonvulsants, mood-stabilizers, antipsychotics) not stable in past 4 weeks, or not expected to remain stable over the main phase of the trial
- Severe alcohol or substance use disorder likely to interfere with treatment
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 |
|---|---|---|
| ExposureSystematic confrontation with stimuli associated with symptom-related distress, to achieve therapeutic changes in cognitions or behavior | Behavioural | Internet-delivered exposure-based treatment |
| Standardized educationStandardized routine care education for individuals suffering from distress related to somatic symptoms, primarily focusing on healthy lifestyle behaviors such as sleep, diet, and exercise | Behavioural | Internet-delivered standardized education and prolonged assessment |
| Prolonged assessmentPatients are encouraged to keep a rudimentary symptom diary to track if and how their symptoms interact with mood and lifestyle behaviors | Behavioural | Internet-delivered standardized education and prolonged assessment |
Primary outcome
Patient Health Questionnaire-15 (PHQ-15)
Time frame: Change over the main phase, as modelled 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.
Theoretical range: 0-30. A higher score indicates a higher subjective somatic symptom burden.
15 secondary outcomes
Somatic Symptom Disorder-B Criteria Scale (SSD-12)
Time frame: Change over the main phase, as modelled 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.
Symptom Preoccupation Scale (preliminary scale)
Time frame: Change over the main phase, as modelled 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.
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 (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 modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment). Additional analyses incorporate 6- and 12-months follow-up assessments.
14-item Health Anxiety Inventory (HAI-14)
Time frame: Screening only
Alcohol Use Disorders Identification Test (AUDIT)
Time frame: Screening only
Drug Use Disorders Identification Test (DUDIT)
Time frame: Screening only
Credibility/Expectancy scale (C/E scale)
Time frame: Week 3 of main phase
Working Alliance Inventory (WAI)
Time frame: Week 3 of main phase
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Primary endpoint assessment (≤45 days after treatment)
EuroQol 5D (EQ-5D)
Time frame: Data from the baseline assessment, the primary endpoint, and the 6- and 12-month follow-up are used for health economic analysis focusing on the main phase.
Trimbos Institute and Institute of Medical Technology Questionnaire for Costs Associated with Psychiatric Illness (TIC-P)
Time frame: Data from the baseline assessment, the primary endpoint, and the 6- and 12-month follow-up are used for health economic analysis focusing on the main phase.
Four questions corresponding to presumed components of subjective somatic symptom burden
Time frame: Measured at screening, baseline assessment, and the primary endpoint
Seven questions probing into basic emotions related to somatic symptoms
Time frame: Measured at screening, baseline assessment, and the primary endpoint
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Results publication: 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.
- Results publication: PubMed 41702998Hybelius J, Af Winklerfelt Hammarberg S, Salomonsson S, Wachtler C, Epstein M, Olsson A, Strand E, Soderstrom Winter L, Ahnlund Hoffmann A, Spansk E, Akerlund T, Bjorkander D, Kosic A, Chahin G, Wallert J, Toth-Pal E, Nordin S, Witthoft M, Axelsson E. Basic emotions reported by individuals with persistent physical symptoms receiving exposure therapy versus healthy lifestyle promotion in primary care. Sci Rep. 2026 Feb 17;16(1):7170. doi: 10.1038/s41598-026-39962-x.
- Simple exposure protocol administered over 10 weeksLink provided by the sponsor.
- 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.
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Safety, Psychological, Acceptability of Health Care
Recruiting
Grappling With Trauma: Brazilian Jiu-Jitsu for First Responders
Post-traumatic Stress Disorder (PTSD), Trauma and Stress Related Disorders
Not yet recruiting
Exposure Therapy for Reactivity to Symptoms
Psychological Factors Affecting Other Medical Conditions, Somatic Symptom and Related Disorders
Active, not recruiting
Interdisciplinary E-health Based Follow-up of Preterm Born Children
Preterm Birth
RecruitingPhase 2
Study of Dextromethorphan in OCD and Related Disorders
Obsessive-Compulsive Disorder, Illness Anxiety Disorder
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.
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 Exposure, Standardized education and Prolonged assessment in people with Somatic Symptom and Related Disorders and Medically Unexplained Symptoms, 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: finished, as of the sponsor's last update on 23 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient Health Questionnaire-15 (PHQ-15) (time frame: Change over the main phase, as modelled 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.). 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 NCT04942028, which also lists 2 linked publications.
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 23 Jun 2026.