Somatic Symptom DisorderSOMEX0NCT04511286
Exposure-Based Treatment for Undifferentiated Somatic Symptom Disorder
A study testing Exposure in people with Somatic Symptom Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This study investigates the feasibility of a general exposure-based treatment protocol that is intended to work for a large variety of patient groups with a clinically significant preoccupation with physical symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Somatic Symptom Disorder
- What is being tested?
- Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSweden
- Study dates
- 11 Sep 2020to 24 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- DSM-5 somatic symptom disorder
- Interest in 8-week intensive psychological treatment to reduce distress and the impact of physical symptoms
- At least 18 years old
- Living in Sweden
- Fluent in Swedish
- Complete pre-treatment assessment
Who cannot join
- Preoccupation with physical symptoms better explained by another psychiatric condition such as illness anxiety disorder, panic disorder, or obsessive-compulsive disorder
- Severe psychiatric condition, such as bipolar disorder, suicidal ideation, or psychosis
- Medical risks associated with participating in exposure-based treatment, or somatic condition - or treatment for somatic condition - that is an obstacle to participating in exposure-based treatment
- Non-stable continuous pharmacotherapy (dosage changed during the past 4 weeks) and the drug is likely to affect outcome measures (primarily: antidepressants, anticonvulsants, benzodiazepines, nonbenzodiazepines, opioids)
- Alcohol or substance use that is a clear obstacle to therapy
- Planned absence for more than 1 week of the treatment period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-Arm Feasibility Study of Exposure-Based Treatment for Undifferentiated Somatic Symptom Disorder
This study investigates the feasibility of a general exposure-based treatment protocol that is intended to work for a large variety of patient groups with a clinically significant preoccupation with physical symptoms. This is a prospective single-group study based at Karolinska Institutet, Stockholm, Sweden, where 40 adults with DSM-5 somatic symptom disorder are enrolled in 8 weeks of therapist-guided exposure-based treatment via the Internet. Exposure is based on general principles but tailored to suit the needs of each patient. Outcomes include patient-reported credibility and expectancy, adherence to the treatment protocol, client satisfaction, and negative events. Within-group effects will also be quantified and discussed in relation to the existing literature.
Read the detailed description
Background:
A substantial portion of patients in routine care suffer from a recurrent preoccupation with physical symptoms, which often leads to substantial suffering and impairment. Exposure-based treatment - where the patient systematically seeks out that which gives rise to unwanted sensations, cognitions, or behavior - has been found to lead to beneficial effects in several types of symptom preoccupation. Yet, this form of treatment is rarely offered in routine care. This may be partially because existing treatment protocols have been developed for specific symptom clusters (e.g., functional somatic syndromes such as irritable bowel syndrome and fibromyalgia) or specific unwanted responses to symptoms (e.g., the fear of having a severe illness), and that many clinics do not have the resources to offer all these specialized protocols in parallel. An alternative approach could be to base exposure treatment on a more general protocol that may be tailored to suit a larger variety of patient groups who suffer from a recurrent preoccupation with physical symptoms. However, it is yet unclear if the use of such a general treatment protocol for symptom preoccupation would be feasible, for example in terms of patient-reported credibility, adherence, identification with the rationale, and general client satisfaction.
Aim:
To investigate the feasibility of delivering exposure-based treatment using a general protocol for clinically significant symptom preoccupation, without selecting patients based on any specific symptom cluster (such as a functional somatic syndrome) or specific unwanted response to physical symptoms (such as a frequent fear of illness).
Design:
This is a prospective single-group feasibility study based at Karolinska Institutet, Stockholm, Sweden, where 40 adults with somatic symptom disorder according to the Diagnostic and statistical manual of mental disorders 5 (DSM-5) are enrolled in 8 weeks of therapist-guided exposure-based treatment that is delivered via the Internet. Various aspects of feasibility are assessed; most notably: patient-reported credibility and expectancy, adherence to the treatment protocol, client satisfaction, and negative events. Within-group effects are also quantified.
- Conditions
- Somatic Symptom Disorder
- Being tested
- Exposure
- Keywords
- Exposure, Feasibility
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
| Study group | Role | What they receive |
|---|---|---|
| Internet-delivered exposure-based treatment | Experimental | Eight weeks of therapist-guided exposure-based treatment delivered via the Internet. Receives: Behavioral: Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility 1: Distribution of Physical Symptoms
According to the Patient Health Questionnaire-15 (PHQ-15, theoretical range: 0-30, higher score indicates more distressing physical symptoms)
Measured: Pre-treatment assessment (within 2 weeks before treatment)
Feasibility 2: Credibility/Expectancy Based on the Credibility/Expectancy Scale
Theoretical range: 0-50, higher score indicates higher credibility/expectancy
Measured: Week 3 of treatment
Feasibility 3: Adherence to the Protocol #1: Percentage Completed Modules in the Sample as a Whole
Preregistered target: at least 60% completed modules in the sample as a whole. In this study, all participants were enrolled in the same type of treatment and were thus offered to work with the same treatment modules. This outcome was the proportion of modules completed in total by all participants, out of the total modules available to all participants.
Measured: Adherence data collected over the entire course of the treatment, up to 8 weeks.
Feasibility 4: Patient-reported Adequacy of Rationale as Assessed Using a Questionnaire Developed Specifically for This Purpose (Theoretical Range: 0-10)
From 0 ("not at all relevant") to 10 ("extremely relevant"). Was originally intended to be administered at week 3, but was administered post-treatment due to an administrative error
Measured: Post-treatment assessment (immediately after treatment, completed within 45 days)
Feasibility 5: Adequacy of the Measurement Strategy
Preregistered target: less than 30% missing data at post-treatment, and at least 75% finding the measurement strategy acceptable (less than 7 on a scale from 0 ["Not at all stressful/bothering"] to 10 ["Extremely stressful/bothering"])
Measured: Post-treatment assessment (immediately after treatment, completed within 45 days)
Feasibility 6: Satisfaction With Treatment as Indicated by a Mean Client Satisfaction Questionnaire (CSQ-8) Score of at Least 22
Theoretical range: 8-32, higher score indicates higher satisfaction. This sum score is based on 8 items, each scored 1-4.
Measured: Post-treatment assessment (immediately after treatment, completed within 45 days)
Feasibility 7a: Adverse Events Measured Using Free-text Items #1: Total Number of Reported Events
The respondent was instructed to describe up to three adverse events.
Measured: Post-treatment assessment (immediately after treatment, completed within 45 days)
Feasibility 7b: Adverse Events Measured Using the 20-item Negative Effects Questionnaire (NEQ-20)
Theoretical range: 0-80, higher score indicates more severe adverse events
Measured: Post-treatment assessment (immediately after treatment, completed within 45 days)
Feasibility 3: Adherence to the Protocol #2: Percentage of Participants Completing at Least 2 Exposure Exercises
Preregistered target: at least 50% of participants completing at least 2 exposure exercises
Measured: Adherence data collected over the entire course of the treatment, up to 8 weeks.
Feasibility 7a: Adverse Events Measured Using Free-text Items #2: Number of Participants Who Reported at Least One Adverse Event
The respondent was instructed to describe up to three adverse events.
Measured: Post-treatment assessment (immediately after treatment, completed within 45 days)
Secondary outcomes (11)
Patient Health Questionnaire-15 (PHQ-15)
Change pre-post, as derived from linear mixed effects regression models fitted by maximum likelihood estimation using data from all 33 participants, and fitted on all 11 measurement points over the treatment phase (from pre-treatment to post-treatment). Theoretical range: 0-30, higher score indicates more distressing physical symptoms
Measured: Screening, pre-treatment assessment (within 2 weeks before treatment), weekly during treatment, Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment
Somatic Symptom Disorder-B Criteria Scale (SSD-12)
Change pre-post, as derived from linear mixed effects regression models fitted by maximum likelihood estimation using data from all 33 participants, and fitted on all 11 measurement points over the treatment phase (from pre-treatment to post-treatment). Theoretical range: 0-48, higher score indicates higher degree of preoccupation with symptoms
Measured: Screening, pre-treatment assessment (within 2 weeks before treatment), weekly during treatment, Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment
Symptom Preoccupation Scale (Preliminary Scale)
Under development, higher score indicates higher degree of preoccupation with symptoms. This is to be regarded as an item pool that will be further analyzed in 2024-2025, and in conjunction with data from other clinical trials. As of September 2023, it is therefore not yet possible to provide a theoretical range for this scale, and it is also not possible to provide outcomes.
Measured: Screening, pre-treatment assessment (within 2 weeks before treatment), weekly during treatment, Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment
14-item Health Anxiety Inventory (HAI-14)
Change pre-post, as derived from linear mixed effects regression models fitted by maximum likelihood estimation using data from all 33 participants, and fitted on all 11 measurement points over the treatment phase (from pre-treatment to post-treatment). Theoretical range: 0-42, higher score indicates more health anxiety
Measured: Screening, pre-treatment assessment (within 2 weeks before treatment), Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment
Anxiety Sensitivity Index (ASI)
Change pre-post, as derived from linear mixed effects regression models fitted by maximum likelihood estimation using data from all 33 participants, and fitted on all 11 measurement points over the treatment phase (from pre-treatment to post-treatment). Theoretical range: 0-64, higher score indicates more anxiety sensitivity
Measured: Screening, pre-treatment assessment (within 2 weeks before treatment), post-treatment assessment Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment
GAD-7
Change pre-post, as derived from linear mixed effects regression models fitted by maximum likelihood estimation using data from all 33 participants, and fitted on all 11 measurement points over the treatment phase (from pre-treatment to post-treatment). Theoretical range: 0-21, higher score indicates more general anxiety
Measured: Pre-treatment assessment (within 2 weeks before treatment), post-treatment assessment Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment
Patient Health Questionnaire (PHQ-9)
Change pre-post, as derived from linear mixed effects regression models fitted by maximum likelihood estimation using data from all 33 participants, and fitted on all 11 measurement points over the treatment phase (from pre-treatment to post-treatment). Theoretical range: 0-27, higher score indicates more symptoms of depression
Measured: Screening, pre-treatment assessment (within 2 weeks before treatment), weekly during treatments (suicidality), post-treatment assesment (immediately after treatment, completed within 45 days), 3 months after treatment
12-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Change pre-post, as derived from linear mixed effects regression models fitted by maximum likelihood estimation using data from all 33 participants, and fitted on all 11 measurement points over the treatment phase (from pre-treatment to post-treatment). Theoretical range: 0-100, higher score indicates more disability
Measured: Screening, pre-treatment assessment (within 2 weeks before treatment), post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment
Alcohol Use Disorders Identification Test (AUDIT)
Theoretical range: 0-40, higher score indicates more problematic alcohol use
Measured: Screening only
Drug Use Disorders Identification Test (DUDIT)
Theoretical range: 0-44, higher score indicates more problematic substance use
Measured: Screening only
Working Alliance Inventory (WAI)
Theoretical range: 6-42, higher score indicates better relationship with the therapist
Measured: Week 3 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start11 Sep 2020
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Somatic Symptom DisorderStudies 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
- Prospective single-group cohort study
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erland Axelsson, Karolinska Institutet
- Investigators
- Erland Axelsson, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511286
- Sponsor's protocol ID
- 2020-01740
- Acronym
- SOMEX0
- Status last verified
- Mar 2025
- First submitted
- 18 Jul 2020
- Last updated
- 19 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 accordingly. 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 study database, link the IPD to an identifiable living natural person.
Publications
Hybelius J, Gustavsson A, Af Winklerfelt Hammarberg S, Toth-Pal E, Johansson R, Ljotsson B, Axelsson E. A unified Internet-delivered exposure treatment for undifferentiated somatic symptom disorder: single-group prospective feasibility trial. Pilot Feasibility Stud. 2022 Jul 19;8(1):149. doi: 10.1186/s40814-022-01105-0.
PubMed 35854392
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Arm Feasibility Study of Exposure-Based Treatment for Undifferentiated Somatic Symptom Disorder
- ClinicalTrials.gov ID
- NCT04511286
- Acronym / sponsor ID
- SOMEX0 / 2020-01740
- Conditions
- Somatic Symptom Disorder
- Keywords
- Exposure, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 13 Aug 2020 (actual)
- Results
- Posted 19 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the feasibility of a general exposure-based treatment protocol that is intended to work for a large variety of patient groups with a clinically significant preoccupation with physical symptoms. This is a prospective single-group study based at Karolinska Institutet, Stockholm, Sweden, where 40 adults with DSM-5 somatic symptom disorder are enrolled in 8 weeks of therapist-guided exposure-based treatment via the Internet. Exposure is based on general principles but tailored to suit the needs of each patient. Outcomes include patient-reported credibility and expectancy, adherence to the treatment protocol, client satisfaction, and negative events. Within-group effects will also be quantified and discussed in relation to the existing literature.
Detailed description
Background:
A substantial portion of patients in routine care suffer from a recurrent preoccupation with physical symptoms, which often leads to substantial suffering and impairment. Exposure-based treatment - where the patient systematically seeks out that which gives rise to unwanted sensations, cognitions, or behavior - has been found to lead to beneficial effects in several types of symptom preoccupation. Yet, this form of treatment is rarely offered in routine care. This may be partially because existing treatment protocols have been developed for specific symptom clusters (e.g., functional somatic syndromes such as irritable bowel syndrome and fibromyalgia) or specific unwanted responses to symptoms (e.g., the fear of having a severe illness), and that many clinics do not have the resources to offer all these specialized protocols in parallel. An alternative approach could be to base exposure treatment on a more general protocol that may be tailored to suit a larger variety of patient groups who suffer from a recurrent preoccupation with physical symptoms. However, it is yet unclear if the use of such a general treatment protocol for symptom preoccupation would be feasible, for example in terms of patient-reported credibility, adherence, identification with the rationale, and general client satisfaction.
Aim:
To investigate the feasibility of delivering exposure-based treatment using a general protocol for clinically significant symptom preoccupation, without selecting patients based on any specific symptom cluster (such as a functional somatic syndrome) or specific unwanted response to physical symptoms (such as a frequent fear of illness).
Design:
This is a prospective single-group feasibility study based at Karolinska Institutet, Stockholm, Sweden, where 40 adults with somatic symptom disorder according to the Diagnostic and statistical manual of mental disorders 5 (DSM-5) are enrolled in 8 weeks of therapist-guided exposure-based treatment that is delivered via the Internet. Various aspects of feasibility are assessed; most notably: patient-reported credibility and expectancy, adherence to the treatment protocol, client satisfaction, and negative events. Within-group effects are also quantified.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective single-group cohort study
| Arm | Type | Receives |
|---|---|---|
| Internet-delivered exposure-based treatment | Experimental | Behavioral: ExposureEight weeks of therapist-guided exposure-based treatment 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)
- DSM-5 somatic symptom disorder
- Interest in 8-week intensive psychological treatment to reduce distress and the impact of physical symptoms
- At least 18 years old
- Living in Sweden
- Fluent in Swedish
Key exclusion criteria (6 listed)
- Preoccupation with physical symptoms better explained by another psychiatric condition such as illness anxiety disorder, panic disorder, or obsessive-compulsive disorder
- Severe psychiatric condition, such as bipolar disorder, suicidal ideation, or psychosis
- Medical risks associated with participating in exposure-based treatment, or somatic condition - or treatment for somatic condition - that is an obstacle to participating in exposure-based treatment
- Non-stable continuous pharmacotherapy (dosage changed during the past 4 weeks) and the drug is likely to affect outcome measures (primarily: antidepressants, anticonvulsants, benzodiazepines, nonbenzodiazepines, opioids)
- Alcohol or substance use that is a clear obstacle to therapy
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 |
Primary outcome
Feasibility 1: Distribution of Physical Symptoms
Time frame: Pre-treatment assessment (within 2 weeks before treatment)
According to the Patient Health Questionnaire-15 (PHQ-15, theoretical range: 0-30, higher score indicates more distressing physical symptoms)
Feasibility 2: Credibility/Expectancy Based on the Credibility/Expectancy Scale
Time frame: Week 3 of treatment
Theoretical range: 0-50, higher score indicates higher credibility/expectancy
Feasibility 3: Adherence to the Protocol #1: Percentage Completed Modules in the Sample as a Whole
Time frame: Adherence data collected over the entire course of the treatment, up to 8 weeks.
Preregistered target: at least 60% completed modules in the sample as a whole. In this study, all participants were enrolled in the same type of treatment and were thus offered to work with the same treatment modules. This outcome was the proportion of modules completed in total by all participants, out of the total modules available to all participants.
Feasibility 4: Patient-reported Adequacy of Rationale as Assessed Using a Questionnaire Developed Specifically for This Purpose (Theoretical Range: 0-10)
Time frame: Post-treatment assessment (immediately after treatment, completed within 45 days)
From 0 ("not at all relevant") to 10 ("extremely relevant"). Was originally intended to be administered at week 3, but was administered post-treatment due to an administrative error
Feasibility 5: Adequacy of the Measurement Strategy
Time frame: Post-treatment assessment (immediately after treatment, completed within 45 days)
Preregistered target: less than 30% missing data at post-treatment, and at least 75% finding the measurement strategy acceptable (less than 7 on a scale from 0 ["Not at all stressful/bothering"] to 10 ["Extremely stressful/bothering"])
Feasibility 6: Satisfaction With Treatment as Indicated by a Mean Client Satisfaction Questionnaire (CSQ-8) Score of at Least 22
Time frame: Post-treatment assessment (immediately after treatment, completed within 45 days)
Theoretical range: 8-32, higher score indicates higher satisfaction. This sum score is based on 8 items, each scored 1-4.
Feasibility 7a: Adverse Events Measured Using Free-text Items #1: Total Number of Reported Events
Time frame: Post-treatment assessment (immediately after treatment, completed within 45 days)
The respondent was instructed to describe up to three adverse events.
Feasibility 7b: Adverse Events Measured Using the 20-item Negative Effects Questionnaire (NEQ-20)
Time frame: Post-treatment assessment (immediately after treatment, completed within 45 days)
Theoretical range: 0-80, higher score indicates more severe adverse events
Feasibility 3: Adherence to the Protocol #2: Percentage of Participants Completing at Least 2 Exposure Exercises
Time frame: Adherence data collected over the entire course of the treatment, up to 8 weeks.
Preregistered target: at least 50% of participants completing at least 2 exposure exercises
Feasibility 7a: Adverse Events Measured Using Free-text Items #2: Number of Participants Who Reported at Least One Adverse Event
Time frame: Post-treatment assessment (immediately after treatment, completed within 45 days)
The respondent was instructed to describe up to three adverse events.
11 secondary outcomes
Patient Health Questionnaire-15 (PHQ-15)
Time frame: Screening, pre-treatment assessment (within 2 weeks before treatment), weekly during treatment, Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment
Somatic Symptom Disorder-B Criteria Scale (SSD-12)
Time frame: Screening, pre-treatment assessment (within 2 weeks before treatment), weekly during treatment, Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment
Symptom Preoccupation Scale (Preliminary Scale)
Time frame: Screening, pre-treatment assessment (within 2 weeks before treatment), weekly during treatment, Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment
14-item Health Anxiety Inventory (HAI-14)
Time frame: Screening, pre-treatment assessment (within 2 weeks before treatment), Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment
Anxiety Sensitivity Index (ASI)
Time frame: Screening, pre-treatment assessment (within 2 weeks before treatment), post-treatment assessment Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment
GAD-7
Time frame: Pre-treatment assessment (within 2 weeks before treatment), post-treatment assessment Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment
Patient Health Questionnaire (PHQ-9)
Time frame: Screening, pre-treatment assessment (within 2 weeks before treatment), weekly during treatments (suicidality), post-treatment assesment (immediately after treatment, completed within 45 days), 3 months after treatment
12-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: Screening, pre-treatment assessment (within 2 weeks before treatment), post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment
Alcohol Use Disorders Identification Test (AUDIT)
Time frame: Screening only
Drug Use Disorders Identification Test (DUDIT)
Time frame: Screening only
Working Alliance Inventory (WAI)
Time frame: Week 3 of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35854392Hybelius J, Gustavsson A, Af Winklerfelt Hammarberg S, Toth-Pal E, Johansson R, Ljotsson B, Axelsson E. A unified Internet-delivered exposure treatment for undifferentiated somatic symptom disorder: single-group prospective feasibility trial. Pilot Feasibility Stud. 2022 Jul 19;8(1):149. doi: 10.1186/s40814-022-01105-0.
- Individual participant dataSharing planned: No. We are willing to consider reasonable requests for individual participant data (IPD) and to consult the responsible parties accordingly. 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 study database, link the IPD to an identifiable living natural person.
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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.
Erland Axelsson, PhD principal investigator
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 in people with Somatic Symptom Disorder, run by Karolinska Institutet 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 19 Mar 2025. 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?
Yes. Results are posted in the registry (first posted 19 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility 1: Distribution of Physical Symptoms (time frame: Pre-treatment assessment (within 2 weeks before treatment)). The study lists 10 primary outcomes in all. 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 NCT04511286, 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 19 Mar 2025.