Status:
COMPLETED
Cognitive-Behavioral Therapy Enriched With Emotion Regulation Training for Multiple Somatoform Symptoms
Lead Sponsor:
Philipps University Marburg
Collaborating Sponsors:
University of Technology Munich
Central Institute of Mental Health, Mannheim
Conditions:
Somatic Symptom Disorder (DSM-V)
Eligibility:
All Genders
18-69 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate whether cognitive-behavioral therapy enriched with strategies from emotion regulation training leads to better improvement in somatic symptoms and comorbid pro...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria (are based on DSM-V diagnosis "somatic symptom disorder \[SSD\] 300.82"):
- Multiple distressing somatic symptoms (≥ 3 symptoms) not fully explained by a medical condition
- PDI ≥ 4
- Patient Health Questionnaire-15 (PHQ-15) ≥ 5
- Requested psychological criteria for SSD (at least 1 of 3):
- Disproportionate and persistent thoughts about the seriousness of one's symptoms
- Persistently high level of anxiety about health or symptoms
- Excessive time and energy devoted to these symptoms or health concerns
- Symptom duration ≥ 6 months
- Age: 18-69 years
- Comorbidity (depression, other mental disorders) allowed, as long as somatic symptoms are considered to be the major problem by therapist and patient
- Thorough medical check for medical disease that might fully explain the somatic symptoms
- Documented medical evaluation
- Exclusion Criteria:
- Severe alcohol/drug addiction
- Acquired brain injuries
- Psychoses (history of schizophrenia spectrum disorders; bipolar disorders)
- Primary disorder requesting other treatments (e.g., suicidality)
- Biomedical etiology of major symptoms (also if detected during treatment course
- Ongoing psychotherapy
- Continuous or intermittent, high-dosage (on average more than once per 2 weeks) benzodiazepine treatment
- Continuous antipsychotic treatment
- Continuous opioid treatment
- For patients on medication with antidepressants: treatment regime changes during the time between 4 weeks prior to treatment until follow-up
Exclusion
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT01908855
Start Date
October 1 2013
End Date
March 1 2017
Last Update
August 11 2017
Active Locations (7)
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1
Justus-Liebig-University, CBT Outpatient Clinic
Giessen, Germany, D-35394
2
University Medical Center Hamburg-Eppendorf, Department of Psychosomatic Medicine
Hamburg, Germany, D-20246
3
University Koblenz-Landau, Department of Clinical Psychology and Psychotherapy
Koblenz-Landau, Germany, D-76829
4
Central Institute of Mental Health, Department of Clinical Psychology
Mannheim, Germany, D-68159