Exposure-Based Treatment for Undifferentiated Somatic Symptom Disorder
Somatic Symptom Disorder
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 18 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 33 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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 full 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not applicable
- Masking
- No masking
Internet-delivered exposure-based treatment
Eight weeks of therapist-guided exposure-based treatment delivered via the Internet.
Behavioral: Exposure
Exposure BEHAVIORAL
Systematic confrontation with stimuli associated with symptom-related distress, to achieve therapeutic changes in cognitions or behavior
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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.
Secondary measures
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
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
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
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
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
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.
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
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
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
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
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
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
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
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
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
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
Alcohol Use Disorders Identification Test (AUDIT)
Time frame: Screening only
Theoretical range: 0-40, higher score indicates more problematic alcohol use
Drug Use Disorders Identification Test (DUDIT)
Time frame: Screening only
Theoretical range: 0-44, higher score indicates more problematic substance use
Working Alliance Inventory (WAI)
Time frame: Week 3 of treatment
Theoretical range: 6-42, higher score indicates better relationship with the therapist
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Karolinska InstitutetStockholm, SwedenStatus unknown
Study team and timeline
- Lead sponsor
- Karolinska Institutet
- Study start
- Sep 11, 2020 Actual
- Primary completion
- Feb 24, 2021 Actual
- Study completion
- Feb 24, 2021 Actual
- First posted
- Aug 13, 2020 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
Single-Arm Feasibility Study of Exposure-Based Treatment for Undifferentiated Somatic Symptom Disorder
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026