Evidence map›Paper›PMID 42432738›Full record

ArticleTrials2026

Efficacy of blended digital and face-to-face psychotherapy compared to enhanced psychotherapy for patients with Somatic Symptom Disorder (iSOMA+): study protocol for a multicenter randomized controlled pragmatic trial.

Freda Kristine Jutzi, Michael Witthöft, Harald Baumeister, Mira Denninger, Winfried Rief, Gaby Bleichhardt, Josef Bailer, Peter Kirsch, Maja Halli-Erkic, Daniela Mier and 13 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors.

Freda Kristine JutziDepartment of Clinical Psychology, Psychotherapy and Experimental Psychopathology, Johannes Gutenberg-University Mainz, Mainz, Germany. frejutzi@uni-mainz.de.ORCID http://orcid.org/0009-0000-6775-6230
Michael WitthöftDepartment of Clinical Psychology and Psychotherapy, Ruhr University Bochum, Bochum, Germany.
Harald BaumeisterDepartment of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.
Mira DenningerDepartment of Clinical Psychology and Psychotherapy, Institute of Psychology and Education, Ulm University, Ulm, Germany.
Winfried RiefDepartment of Clinical Psychology and Psychotherapy, University of Marburg, Marburg, Germany.
Gaby BleichhardtDepartment of Clinical Psychology and Psychotherapy, University of Marburg, Marburg, Germany.
Josef BailerDepartment of Clinical Psychology, Medical Faculty Mannheim, Central Institute of Mental Health/University of Heidelberg, Mannheim, Germany.
Peter KirschDepartment of Clinical Psychology, Medical Faculty Mannheim, Central Institute of Mental Health/University of Heidelberg, Mannheim, Germany.
Maja Halli-ErkicDepartment of Clinical Psychology, Medical Faculty Mannheim, Central Institute of Mental Health/University of Heidelberg, Mannheim, Germany.
Daniela MierDepartment of Clinical Psychology and Psychotherapy, University of Konstanz, Konstanz, Germany.
Mara MankinDepartment of Clinical Psychology and Psychotherapy, University of Konstanz, Konstanz, Germany.
Julia A GlombiewskiDepartment of Clinical Psychology and Psychotherapy, RPTU University Kaiserslautern-Landau, Landau, Germany.
Rabea VogtDepartment of Clinical Psychology and Psychotherapy, RPTU University Kaiserslautern-Landau, Landau, Germany.
Jens HeiderDepartment of Clinical Psychology and Psychotherapy, RPTU University Kaiserslautern-Landau, Landau, Germany.
Frank JacobiDepartment of Clinical Psychology and Psychotherapy, Psychologische Hochschule Berlin, Berlin, Germany.
Alexandra MartinDepartment of Clinical Psychology and Psychotherapy, University of Wuppertal, Wuppertal, Germany.
Barbara Schulte-HolthausenDepartment of Clinical Psychology and Psychotherapy, University of Wuppertal, Wuppertal, Germany.
Kai KronfeldInterdisciplinary Center Clinical Trials (IZKS), University Medical Center Mainz, Mainz, Germany.
Stanislav GorbulevInterdisciplinary Center Clinical Trials (IZKS), University Medical Center Mainz, Mainz, Germany.
Christian RuckesInterdisciplinary Center Clinical Trials (IZKS), University Medical Center Mainz, Mainz, Germany.
Rüdiger PryssInstitute of Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany.
Robin KraftInstitute of Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany.
Severin HennemannDepartment of Clinical Psychology, Psychotherapy and Experimental Psychopathology, Johannes Gutenberg-University Mainz, Mainz, Germany.

Funding

Deutsche Forschungsgemeinschaft 543351897
6 · The paper itself

Abstract

backgroundPersistent somatic symptoms (PSS) that occur in various somatic, functional, or mental health conditions can lead to considerable psychological distress and functional impairment. As such, they are a key characteristic of the Somatic Symptom Disorder (SSD) in DSM-5. While psychological treatments such as cognitive behavioral approaches can address these symptoms, their clinical efficacy in reducing symptom burden in previous trials remains limited. Blended psychotherapy, i.e., combining face-to-face psychotherapy with digital elements, is a promising new approach to efficiently enhance psychotherapeutic effects. This study therefore aims to evaluate the efficacy, mechanisms, and safety of blended psychotherapy compared to enhanced standard psychotherapy for individuals with SSD in outpatient psychotherapy.

methodsA two-armed, multicenter randomized controlled pragmatic trial will be conducted, and N = 250 adults with SSD will be randomized to either blended psychotherapy (20 individual sessions of cognitive behavioral therapy (CBT) + accompanying digital intervention; iSOMA+) or enhanced CBT (20 sessions of CBT + self-help booklet; CBT+). Participants are recruited at eight German university outpatient psychotherapy clinics. Assessments will be conducted at patient study inclusion (pre-treatment), during treatment, post-treatment, and 6 months follow-up. The primary outcome is the reduction in somatic symptom severity using the Screening for Somatoform Disorders (SOMS-7R) from baseline to post-treatment. Secondary outcomes include changes in symptom-related distress, coping, self-efficacy, as well as depression, anxiety, health anxiety, disability, quality of life, interpersonal relationship experiences and patient safety. Additionally, several potential moderators and mediators, including patient and intervention characteristics, will be examined. DISCUSSION: This trial investigates the potential of blended CBT for improving treatment outcomes in patients with SSD and will provide evidence on the effects of active vs. passive self-help as treatment augmentation under pragmatic care conditions. By identifying prescriptive factors of treatment response, the study will support personalized care and contribute to more accessible and efficacious treatment options for patients with PSS.

trial registrationGerman Clinical Trials Register (DRKS) DRKS00035250. Registered on 13.06.2025, https://drks.de/search/de/trial/DRKS00035250 .

Indexed as

Cognitive Behavioral TherapyMedically Unexplained SymptomsPsychotherapySomatoform DisordersAdultFemaleGermanyHumansMental Health TeletherapyMulticenter Studies as TopicPragmatic Clinical Trials as TopicQuality of LifeTreatment OutcomeBlended psychotherapyInternet interventionPersistent somatic symptomsRandomized controlled trialSomatic Symptom Disorder

Identifiers

PMID42432738
PMCPMC13352642

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.