Rief 2013.

Trial name or title	Enriching Cognitive‐Behavioral Therapy With Emotion Regulation Training in Patients With Chronic Multiple Somatoform Symptoms (ENCERT): A Randomized Controlled Trial
Methods	Randomised controlled trial
Participants	Participants 18‐69 years with inclusion Criteria based on DSM‐V diagnosis "somatic symptom disorder [SSD] 300.82"
Interventions	ENCERT contains 1. psychoeducation (session 1), 2. relaxation techniques for coping with stress (sessions 2‐4), 3. non‐judgmental awareness of body perceptions, (sessions 5‐7), 4. modifying illness behaviour and accepting unpleasant body perceptions (sessions 8‐13), 5. attention defocusing on positive perceptions plus emotional self support (sessions 14‐15), 6. analysing interpretation processes to understand situational cues (sessions 16‐17), and 7. change of behaviour and interpretations (sessions 18‐20). The innovative elements of ENCERT are: improving the awareness for the association of somatic symptoms with emotions, learning non‐judgmental awareness and acceptance of unpleasant body perceptions, achieving high‐frequent skill exercising with the emotion regulation audio training. Comparator: CBT. This arm is based on traditional cognitive‐behavioural 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 manualised program includes the following components focusing on the special needs of people with chronic somatoform disorders: psychoeducation providing a framework for psychotherapy, attention defocusing, reduction of over‐interpretation of symptoms, increase of physical activity, stress reduction
Outcomes	Primary Outcome Measures:Change in somatic symptom severity (Screening for Somatoform Disorders, SOMS‐7T) from pre‐assessment to four in‐between assessments to post‐assessment to follow‐up [Time Frame: From pre‐assessment (admission) to four in‐between assessments (9, 13, 17, 21 weeks after admission) to post‐assessment (25 weeks after admission) to follow‐up (12 months after admission) ] [ Designated as safety issue: No ]Assessment of somatic symptom severity during the last 7 days (self rating) Secondary Outcome Measures:Change in depressive symptoms (Beck Depression Inventory‐II, BDI‐II) from pre‐assessment to one in‐between assessment to post‐assessment to follow‐up [ Time Frame: From pre‐assessment (admission) to one in‐between assessment (13 weeks after admission) to post‐assessment (25 weeks after admission) to follow‐up (12 months after admission) ] [ Designated as safety issue: No ]Assessment of depressive symptoms (self rating) Change in emotion regulation skills (Emotion Regulation Skills Questionnaire, ERSQ) from pre‐assessment to one in‐between assessment to post‐assessment to follow‐up [ Time Frame: From pre‐assessment (admission) to one in‐between assessment (13 weeks after admission) to post‐assessment (25 weeks after admission) to follow‐up (12 months after admission) ] [ Designated as safety issue: No ]Assessment of emotion regulation skills (self rating) Change in symptom‐focused coping strategies (Pain Coping Questionnaire, FESV; Geissner, 2003) from pre‐assessment to one in‐between assessment to post‐assessment to follow‐up [ Time Frame: From pre‐assessment (admission) to one in‐between assessment (13 weeks after admission) to post‐assessment (25 weeks after admission) to follow‐up (12 months after admission) ] [ Designated as safety issue: No ]Assessment of symptom‐focused coping strategies (self rating) Change in general psychopathological symptoms (Symptom Checklist‐90, SCL‐90) from pre‐assessment to one in‐between assessment to post‐assessment to follow‐up [ Time Frame: From pre‐assessment (admission) to one in‐between assessment (13 weeks after admission) to post‐assessment (25 weeks after admission) to follow‐up (12 months after admission) ] [ Designated as safety issue: No ]Assessment of general psychopathological symptoms (self rating) Change in symptom‐caused disability (Pain Disability Index, PDI) from pre‐assessment to one in‐between assessment to post‐assessment to follow‐up [ Time Frame: From pre‐assessment (admission) to one in‐between assessment (13 weeks after admission) to post‐assessment (25 weeks after admission) to follow‐up (12 months after admission) ] [ Designated as safety issue: No ]Assessment of symptom‐caused disability in different areas of life (self rating) Change in health‐related quality of life (EuroQoL‐5D, EQ‐5D) from pre‐assessment to one in‐between assessment to post‐assessment to follow‐up [ Time Frame: From pre‐assessment (admission) to one in‐between assessment (13 weeks after admission) to post‐assessment (25 weeks after admission) to follow‐up (12 months after admission) ] [ Designated as safety issue: No ]Assessment of health‐related quality of life (self rating) Change in health anxiety (Whiteley Index, WI) from pre‐assessment to one in‐between assessment to post‐assessment to follow‐up [ Time Frame: From pre‐assessment (admission) to one in‐between assessment (13 weeks after admission) to post‐assessment (25 weeks after admission) to follow‐up (12 months after admission) ] [ Designated as safety issue: No ]Assessment of health anxiety (self rating) Change in social competence, emotion regulation, relaxation abilities, stress management, etc., in different areas of life (The Operationalized Assessment of Abilities, OFD) from pre‐assessment to post‐assessment to follow‐up [ Time Frame: From pre‐assessment (admission) to post‐assessment (25 weeks after admission) to follow‐up (12 months after admission) ] [ Designated as safety issue: No ]Observer‐based assessment of scores for social competence, emotion regulation, relaxation abilities, stress management, etc., in different areas of life (job, family, leisure) Change in healthcare utilisation and indirect costs (Structured Interview for the Assessment of Health Care Utilization, HCU) from pre‐assessment to follow‐up [ Time Frame: From pre‐assessment (admission) to follow‐up (12 months after admission) ] [ Designated as safety issue: No ]Observer‐based assessment of HCU and indirect costs. HCU will be transformed to costs using health economy tables Inventory of the Assessment of Negative Effects of Psychotherapy (INEP) at post‐assessment [ Time Frame: Post‐assessment (25 weeks after admission) ] [ Designated as safety issue: No ]Assessment of psychotherapy‐induced side effects (self rating) Inventory of the Assessment of Negative Effects of Psychotherapy (INEP) at follow‐up [ Time Frame: Follow‐up (12 months after admission) ] [ Designated as safety issue: No ]Assessment of psychotherapy‐induced side effects (self rating)
Starting date	October 2013
Contact information	Winfried Rief, Ph.D. riefw@uni‐marburg.de Maria Kleinstäuber maria.kleinstaeuber@Staff.Uni‐Marburg.de
Notes	ClinicalTrials.gov identifier: NCT01908855. Results expected 2016