CBT Enriched With Emotion Regulation Training for Multiple Somatoform Symptoms (ENCERT) - A 3-year Follow-up (ENCERT-3YFU)
Somatic Symptom Disorder (DSM-5)
About this trial
This is an interventional treatment trial for Somatic Symptom Disorder (DSM-5) focused on measuring somatoform symptoms, somatic symptoms, somatoform disorder, somatic symptom disorder, cognitive-behavioral therapy, emotion regulation training, 3-year follow-up
Eligibility Criteria
Inclusion Criteria (are based on DSM-5 diagnosis "somatic symptom disorder [SSD] 300.82"):
- Multiple distressing somatic symptoms (≥ 3 symptoms) not fully explained by a medical condition
- Pain Disability Index (mPDI) total score ≥ 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
Sites / Locations
- Department of Psychology, Philipps University MarburgRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
CBT complemented with emotion regulation training
Cognitive behavior therapy (CBT)
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.
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.