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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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“The set of outcomes follows the recommendations of the European expert network of clinicians and researchers on persistent somatic symptoms (EURONETSOMA) designed to harmonize core outcome domains in clinical trials on PPS (Rief et al., 2017).”
BackgroundKlewinghaus, L., & Martin, A. (2022) · Verhaltenstherapie · doi:10.1159/000522419 · Cited by 7
Self-citationJunge, M., Hüsing, P., Löwe, B., & Weigel, A. (2023) · Journal of Psychosomatic Research · doi:10.1016/j.jpsychores.2023.111347 · Cited by 6
Self-citationPersonalized treatment outcomes in patients with somatoform disorder: A concept mapping study
Klemm, S., Kloth, S. A. M., van Vliet, S., Oosterhuis, L., & Geenen, R. (2018) · Journal of Psychosomatic Research · doi:10.1016/j.jpsychores.2018.03.009 · Cited by 11
“…may re fl ect that somatoform disorder is di ffi cult to treat or that outcome measurements are not su ffi ciently sensitive to change and show large variability [22], an additional explanation is that the commonly used outcome measures do not validly re fl ect the changes that are pursued in treatment.”
Ajluni, V. (2024) · Journal of General and Family Medicine · doi:10.1002/jgf2.725 · Cited by 5
Kitselaar, W. M., Büchner, F. L., van der Vaart, R., Sutch, S. P., Bennis, F. C., Evers, A. W. M., & Numans, M. E. (2023) · BMJ Open · doi:10.1136/bmjopen-2022-066183 · Cited by 6
Hüsing, P., Löwe, B., Hartman, T. O., Frostholm, L., & Weigel, A. (2021) · BMJ Open · doi:10.1136/bmjopen-2020-044244 · Cited by 5
Self-citationPedersen, H. F., Lamm, T. T., Fink, P., Ørnbøl, E., & Frostholm, L. (2023) · Contemporary Clinical Trials Communications · doi:10.1016/j.conctc.2023.101069 · Cited by 4
Self-citationEngelmann, P., Löwe, B., & Hüsing, P. (2022) · Internet Interventions · doi:10.1016/j.invent.2022.100582 · Cited by 4
Self-citationFuncData - A national database for functional somatic disorders in Denmark
Eefsen, A. M., Petersen, M. W., Vægter, H. B., Fonager, K., Skjernov, M., Gormsen, L. K., & Schröder, A. (2022) · Journal of Psychosomatic Research · doi:10.1016/j.jpsychores.2022.111092 · Cited by 5
Self-citationMartin, A., & Rief, W. (2020) · Springer eBooks · doi:10.1007/978-3-662-61814-1_53 · Cited by 4
Self-citationHahn, S., Nestoriuc, Y., Kirchhof, S., Toussaint, A. C., Löwe, B., & Pauls, F. (2025) · BMJ Open · doi:10.1136/bmjopen-2024-091032 · Cited by 5
“It accounts for up to 90% of the most frequently reported somatic symptoms of patients (eg, low energy, headache, constipation).”
Self-citationKahnert, S., Kämpfer, N., Ramm, M., Geiser, F., & Conrad, R. (2025) · Journal of Psychosomatic Research · doi:10.1016/j.jpsychores.2025.112381 · Cited by 3
Kallesøe, K. H., Ørnbøl, E., Wellnitz, K. B., & Rask, C. U. (2025) · Cognitive Behaviour Therapy · doi:10.1080/16506073.2025.2521719 · Cited by 3
“…perceived physical health (PPH) derived from the SF-36 subscales of physical functioning (PF, 10 items), bodily pain (BP, 2 items), and vitality (VT, 4 items) shown to be sensitive to change in key areas affected in adults with FSD (Bjorner et al., 1998; Rief et al., 2017; Schroder et al., 2012).”
Engelmann, P., Busmann, M., Löwe, B., & Hüsing, P. (2025) · Journal of Psychosomatic Research · doi:10.1016/j.jpsychores.2025.112500 · Cited by 2
Self-citationHahn, S., Pauls, F., Wittenbecher, H., Maehder, K., Löwe, B., Blankenburg, K., Toussaint, A. C., & Nestoriuc, Y. (2026) · Journal of Psychosomatic Research · doi:10.1016/j.jpsychores.2026.112546 · Cited by 2
Self-citationHoheisel, M., Popkirov, S., Michaelis, R., & Rose, M. (2024) · Complex Psychiatry · doi:10.1159/000536668 · Cited by 4
“…the multifactorial nature of SSD and suggests that a comprehensive approach, considering both the B-criteria and other psychobehavioral factors, may be necessary for further validation and treatment of SSD, as has been stimulated by recent research, e.g., from the EURONET-SOMA group [41, 42].”
MethodMa, J., Zheng, L., Chen, R., Ren, J., Chen, H., Zhang, Y., Li, W., Ma, X., Lu, W. D., Wu, H., et al. (2022) · BMC Psychiatry · doi:10.1186/s12888-022-04342-y · Cited by 2
Self-citationAgger, J. L., Schröder, A., Ørnbøl, E., Jensen, J. S., Pedersen, H. F., Fink, P., & Gormsen, L. K. (2022) · Psychiatry Research · doi:10.1016/j.psychres.2022.114474 · Cited by 1
Self-citationKognitive Verhaltenstherapie mit Herzratenvariabilitäts-Biofeedback bei chronischen Schmerzen
Wünsche, S., Krempel, L., & Martin, A. (2024) · Die Psychotherapie · doi:10.1007/s00278-024-00732-7 · Cited by 1
Self-citationGlobal research status and trends of somatic symptom disorder: A bibliometric study
Yang, C., Zhang, K., Wang, Q., Wang, S., Li, H., & Zhang, K. (2024) · World Journal of Psychiatry · doi:10.5498/wjp.v15.i1.100730 · Cited by 1
Richardson, M., Kleinstäuber, M., & Wong, D. K. (2025) · Movement Disorders · doi:10.1002/mds.30195 · Cited by 1
“22 The primary outcome and end-point was the Short Form Health Survey (SF-36) Physical Functioning subscale at the 8-week follow-up.”
Self-citationMaroti, D., Ljungdahl, M., Petersen, H., Rööst, M., Falkenström, F., & Lilliengren, P. (2025) · Psychosomatic Medicine · doi:10.1097/psy.0000000000001424 · Cited by 2
Madsen, M. M., Trolle, C., Fynne, L. V., Colombo, M., Pedersen, R. L., Sørensen, V., Christensen, S. R., Fink, P., & Gormsen, L. K. (2025) · Contemporary Clinical Trials · doi:10.1016/j.cct.2025.108082 · Cited by 1
Maroti, D., Ljungdahl, M., Petersen, H., Rööst, M., Lumley, M. A., Falkenström, F., & Lilliengren, P. (2026) · Internet Interventions · doi:10.1016/j.invent.2026.100942 · Cited by 2
Hüsing, P., Busmann, M., Löwe, B., & Engelmann, P. (2025) · Internet Interventions · doi:10.1016/j.invent.2025.100892 · Cited by 1
Self-citation
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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