An interventional study of Cognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptoms and Cognitive-behavioral therapy for patients with multiple somatoform symptoms in Somatic Symptom Disorder (DSM-5), sponsored by Philipps University Marburg. Completed at 1 site in Germany. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2025-07-14.
Sponsored by Philipps University Marburg · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate whether 3 years after the end of therapy cognitive-behavioral therapy complemented with strategies from emotion regulation training leads to better improvement in somatic symptoms and comorbid problems in patients with chronic multiple somatoform symptoms than cognitive behavioral therapy alone.
Somatic symptoms not caused by a known biomedical condition ("somatoform disorders") are highly prevalent, involve a high risk of chronicity, are one of the major reasons for doctor visits, and are a tremendous burden for health care systems. Despite the economic relevance, research activities are disproportionately low. The only intervention with an evidence grade I is cognitive behavioral therapy (CBT). However, average effect sizes for CBT in somatization syndromes are only moderate (Cohen's d \< 0.5), and more powerful interventions are needed.
There is convincing evidence that patients with somatoform disorders have emotion regulation deficits, which are not addressed by current CBT approaches. We conducted a randomized controlled trial in which we compared a conventional CBT for patients with chronic multiple somatoform symptoms with CBT complemented with emotion regulation techniques (ENCERT; see ClinicalTrials.gov ID: NCT01908855). Previous interventional studies have mainly focused on acute effects and rarely include follow-up periods > 2 years after the end of therapy. The primary goal of the proposed project is to investigate whether effects that were demonstrated for both treatments in our previous randomized controlled trial can be maintained until 3 years after the end of therapy.
This study is based on the intention-to-treat (ITT) sample (N=255 patients) of our previous randomized controlled trial (ClinicalTrials.gov ID: NCT01908855). Patients were primarily recruited via referrals by primary care doctors. After a screening phase baseline assessments with different self- and clinician rating scales (see Outcome Measures) followed. Participants who fulfilled the eligibility criteria were randomized to one of the two study arms: cognitive behavioral therapy vs. cognitive-behavioral therapy complemented with emotion regulation strategies. The post assessment took place after the 20th therapy session and at a follow-up at six months after post treatment. In the current project all randomized patients will be reassessed 3 years after the end of therapy.
Different methods were applied to prevent bias and to assure a high quality level of the current study. Data handling, data monitoring and statistical analyses were supervised by the Coordinating Center for Clinical Trials (KKS) of Philipps-University of Marburg; data quality and safety principles were applied. Additionally an independent Data Safety Monitoring Board was nominated. Randomisation occured and was controlled centrally through the randomisation's central office in KKS Marburg. The current study qualifies as a single-blinded trial. Assessment interviews are conducted and analyzed by people blinded to the treatment condition. Treatments in the previous randomized controlled trial were manualized, and therapists received an intense training. Treatment fidelity/integrity were analyzed with rating schemes for an priori defined proportion of randomly selected videotaped treatment sessions. Allowed additional treatments during study inclusion were thoroughly monitored and analyzed.
The sample size calculation was based on the primary outcome variable "somatization severity index" of the Screening of Somatoform Disorders (SOMS-7T). Based on results of the main validation study of SOMS-7T, metaanalytic estimations, and results of a pilot study of the efficacy of ENCERT, the power calculations yield a necessary total sample size of N=194 to detect a clinical relevant difference of 4 points symptom reduction on SOMS-7T between the two treatments with a power of 0.80 and an alpha=.05. With regard to an estimated drop-out rate of 25%, N=255 patients were recruited.
As main efficacy analysis the primary outcome shall be analyzed with linear mixed-effect models according to the ITT principle. Multilevel longitudinal mediation analyses will be conducted in order to test whether the effect of treatment condition on intraindividual changes in somatic symptom severity can be explained by intraindividual changes in emotion regulation skills.
71 studies on the registry are indexed under Medically Unexplained Symptoms; 22 are open to participants now.
This study's enrollment of 255 is above the median of 68 across 53 interventional studies indexed under Medically Unexplained Symptoms.
Browse Medically Unexplained Symptoms studies →Philipps University Marburg is the lead sponsor of 116 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (are based on diagnosis "somatic symptom disorder [SSD] 300.82"):
Requested psychological criteria for SSD (at least 1 of 3):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ENCERT contains 1) psychoeducation (session1), 2) relaxation techniques for coping with stress (sessions 2-4), 3) non-judgmental awareness of body perceptions, (sessions 5-7), 4) modifying illness behavior and accepting unpleasant body perceptions (sessions 8-13), 5) attention defocusing on positive perceptions plus emotional self-support (sessions 14- 15), 6) analyzing interpretation processes to understand situational cues (sessions 16-17), and 7) change of behavior and interpretations (sessions 18-20). The innovative elements of ENCERT are: improving the awareness for the association of somatic symptoms with emotions, learning nonjudgmental awareness and acceptance of unpleasant body perceptions, achieving high-frequent skill exercising with the emotion regulation audio training.
Behavioral: Cognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptoms
This arm is based on conventional cognitive-behavioral therapy that can be considered the current "treatment of choice", being the only intervention with an evidence grade 1a (Kroenke, 2007). As such, it presents the reference of efficacy and safety for new regimen. The strictly manualized program includes the following components focusing on the special needs of chronic somatoform patients: psychoeducation providing a framework for psychotherapy, attention defocusing, reduction of over-interpretation of symptoms, increase of physical activity, stress reduction.
Behavioral: Cognitive-behavioral therapy for patients with multiple somatoform symptoms
Cognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptoms: 20 weekly sessions individual therapy (à 50 minutes)
Cognitive-behavioral therapy for patients with multiple somatoform symptoms: 20 weekly sessions individual therapy (à 50 minutes)
Change in somatic symptom severity (Screening of Somatoform Disorders, SOMS-7T) from pre-assessment to 3-year follow-up
Assessment of somatic symptom severity during the last 7 days (self-rating)
Time frame: From pre-assessment (admission) to follow-up (42 months after admission)
Change in depressive symptoms (Beck Depression Inventory-II, BDI-II) from pre-assessment to 3-year follow-up
Assessment of depressive symptoms (self-rating)
Time frame: From pre-assessment (admission) to follow-up (42 months after admission)
Change in emotion regulation skills (Emotion Regulation Skills Questionnaire, ERSQ) from pre-assessment to 3-year follow-up
Assessment of emotion regulation skills (self-rating)
Time frame: From pre-assessment (admission) to follow-up (42 months after admission)
Change in symptom-focused coping strategies (Pain Coping Questionnaire) from pre-assessment to 3-year follow-up
Assessment of symptom-focused coping strategies (self-rating)
Time frame: From pre-assessment (admission) to follow-up (42 months after admission)
Change in general psychopathological symptoms (Symptom Checklist-90, SCL-90) from pre-assessment to 3-year follow-up
Assessment of general psychopathological symptoms (self-rating)
Time frame: From pre-assessment (admission) to follow-up (42 months after admission)
Change in symptom-caused disability (Pain Disability Index, PDI) from pre-assessment to 3-year follow-up
Assessment of symptom-caused disability in different areas of life (self-rating)
Time frame: From pre-assessment (admission) to follow-up (42 months after admission)
Change in health-related quality of life (EuroQoL-5D, EQ-5D) from pre-assessment to 3-year follow-up
Assessment of health-related quality of life (self-rating)
Time frame: From pre-assessment (admission) to follow-up (42 months after admission)
Change in health anxiety (modified Short Health Anxiety Inventory, mSHAI) from pre-assessment to 3-year follow-up
Assessment of health anxiety (self-rating)
Time frame: From pre-assessment (admission) to follow-up (42 months after admission)
Plan to share: Yes — Data sharing statement Will individual participant data be available (including data dictionaries)? Yes What data in particular will be shared? Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices). What other documents will be available? Study protocol With whom? Researchers who provide a methodologically sound proposal for re-analyses For what types of analyses? For re-analyses if their aim is covered by the purpose described and agreed on in the patient information sheet and informed consent.
Supporting information: Study protocol
Time frame: Immediately following publication; no end date
Access criteria: Proposals should be directed to the corresponding author (MK; maria.kleinstaeuber@staff.uni-marburg.de). To gain access, data requestors will need to sign a data access agreement. Data are not publicly available because informed consent provided by participants of this study is committed to a defined purpose.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medically Unexplained Symptoms →