N/A
N=33
Exposure-Based Treatment for Undifferentiated Somatic Symptom Disorder
Somatic Symptom Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04511286 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Feasibility 1: Distribution of Physical Symptoms — 11.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exposure (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Karolinska Institutet
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility 1: Distribution of Physical Symptoms |
11.8 | — |
| PRIMARY Feasibility 2: Credibility/Expectancy Based on the Credibility/Expectancy Scale |
34.5 | — |
| PRIMARY Feasibility 3: Adherence to the Protocol #1: Percentage Completed Modules in the Sample as a Whole |
150 | — |
| PRIMARY Feasibility 4: Patient-reported Adequacy of Rationale as Assessed Using a Questionnaire Developed Specifically for This Purpose (Theoretical Range: 0-10) |
8.4 | — |
| PRIMARY Feasibility 5: Adequacy of the Measurement Strategy |
1; 27 | — |
| PRIMARY Feasibility 6: Satisfaction With Treatment as Indicated by a Mean Client Satisfaction Questionnaire (CSQ-8) Score of at Least 22 |
25.3 | — |
| PRIMARY Feasibility 7a: Adverse Events Measured Using Free-text Items #1: Total Number of Reported Events |
6 | — |
| PRIMARY Feasibility 7b: Adverse Events Measured Using the 20-item Negative Effects Questionnaire (NEQ-20) |
5.7 | — |
| PRIMARY Feasibility 3: Adherence to the Protocol #2: Percentage of Participants Completing at Least 2 Exposure Exercises |
32 | — |
| PRIMARY Feasibility 7a: Adverse Events Measured Using Free-text Items #2: Number of Participants Who Reported at Least One Adverse Event |
5 | — |
| SECONDARY Patient Health Questionnaire-15 (PHQ-15) |
-4.2 | — |
| SECONDARY Somatic Symptom Disorder-B Criteria Scale (SSD-12) |
-13.0 | — |
| SECONDARY Symptom Preoccupation Scale (Preliminary Scale) |
— | — |
| SECONDARY 14-item Health Anxiety Inventory (HAI-14) |
-6.7 | — |
| SECONDARY Anxiety Sensitivity Index (ASI) |
-9.5 | — |
| SECONDARY GAD-7 |
-3.4 | — |
| SECONDARY Patient Health Questionnaire (PHQ-9) |
-3.2 | — |
| SECONDARY 12-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) |
-8.8 | — |
| SECONDARY Alcohol Use Disorders Identification Test (AUDIT) |
4.7 | — |
| SECONDARY Drug Use Disorders Identification Test (DUDIT) |
0.2 | — |
| SECONDARY Working Alliance Inventory (WAI) |
35.2 | — |
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. 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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04511286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.