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Core Outcome Domains for Clinical Trials on Somatic Symptom Disorder, Bodily Distress Disorder, and Functional Somatic Syndromes: European Network on Somatic Symptom Disorders Recommendations
Open accessAbstract
OBJECTIVE: The harmonization of core outcome domains in clinical trials facilitates comparison and pooling of data, and simplifies the preparation and review of research projects and comparison of risks and benefits of treatments. Therefore, we provide recommendations for the core outcome domains that should be considered in clinical trials on the efficacy and effectiveness of interventions for somatic symptom disorder, bodily distress disorder, and functional somatic syndromes. METHODS: The European Network on Somatic Symptom Disorders group of more than 20 experts in the field met twice in Hamburg to discuss issues of assessment and intervention research in somatic symptom disorder, bodily distress disorder, and functional somatic syndromes. The consensus meetings identified core outcome domains that should be considered in clinical trials evaluating treatments for somatic symptom disorder and associated functional somatic syndromes. RESULTS: The following core domains should be considered when defining ascertainment methods in clinical trials: a) classification of somatic symptom disorder/bodily distress disorder, associated functional somatic syndromes, and comorbid mental disorders (using structured clinical interviews), duration of symptoms, medical morbidity, and prior treatments; b) location, intensity, and interference of somatic symptoms; c) associated psychobehavioral features and biological markers; d) illness consequences (quality of life, disability, health care utilization, health care costs; e) global improvement and treatment satisfaction; and f) unwanted negative effects. CONCLUSIONS: The proposed criteria are intended to improve synergies of clinical trials and to facilitate decision making when comparing different treatment approaches. These recommendations should not result in inflexible guidelines, but increase consistency across investigations in this field.
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“and is chosen based on the recommendations from consensus groups in pain research and FSD [40,41].”
From Internet-delivered treatment for patients suffering from severe functional somatic disorders: Protocol for a randomized controlled trial (2023) · cites this paper as [41]
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“The assessment of self-ratings is in line with the recommendations by the EURONET-SOMA group [57].”
From Efficacy and Acceptance of Cognitive Behavioral Therapy in Adults with Chronic Fatigue Syndrome: A Meta-analysis. (2024) · cites this paper as [57]
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“the two numeric analog scale items on symptom intensity and symptom interference recommended by the European Network on Somatic Symptom Disorders in future adult trials (Rief et al., 2017)”
From Third wave treatments for functional somatic syndromes and health anxiety across the age span: A narrative review (2019) · cites this paper as Rief et al., 2017
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Management of functional somatic syndromes and bodily distress
Henningsen, P., Zipfel, S., Sattel, H., & Creed, F. (2018) · Psychotherapy and Psychosomatics · doi:10.1159/000484413 · Cited by 335
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Self-citationSomatic symptom disorder: a scoping review on the empirical evidence of a new diagnosis
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BackgroundSelf-citationMethodological Recommendations for Trials of Psychological Interventions
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Metadata
- Authors
- Rief, W., Burton, C., Frostholm, L., Henningsen, P., Kleinstäuber, M., Kop, W. J., Löwe, B., Martin, A., Malt, U., Rosmalen, J., Schröder, A., Shedden-Mora, M., Toussaint, A., & van der Feltz-Cornelis, C.
- Affiliations
- Philipps University of Marburg (DE)
- Corresponding author
- Rief, Winfried
- ORCID
- Venue
- Psychosomatic Medicine
- Published
- 2017-11
- Volume
- 79
- Issue
- 9
- Pages
- 1008-1015
- ISSN
- 0033-3174 (ISSN-L)
- 1534-7796
- OpenAlex
- W2728172048
- Cited by
- 129
- References
- 65
- Citations by year
- 2026: 12 · 2025: 16 · 2024: 16 · 2023: 15 · 2022: 20 · 2021: 12 · 2020: 15 · 2019: 10 · 2018: 10 · 2017: 3
- FWCI
- 8.54
- Type
- journal article
- Language
- en
- Open access
- Licence
- other-oa
- Locations
- Psychosomatic Medicine (publishedVersion)
- PubMed (publishedVersion)
- Digital Commons - USU (Utah State University) (submittedVersion)
- Research portal (Tilburg University) (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
- ResearchSpace (University of Auckland) (submittedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Psychosomatic Disorders and Their Treatments
- Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
- Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Medical Practices and Rehabilitation
- Keywords
- core outcome domains, somatic symptom disorder, functional somatic syndromes, clinical trial reporting, quality of life, disability, health care utilization, health care costs, treatment satisfaction, adverse effects, biomarkers, comorbid mental disorders, symptom duration
- MeSH terms
- Medically Unexplained Symptoms, Clinical Trials as Topic, Europe, Humans, Psychophysiologic Disorders, Societies, Medical, Somatoform Disorders, Outcome Assessment, Health Care
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