Cognitive-Behavioral Therapy Enriched With Emotion Regulation Training for Multiple Somatoform Symptoms

Study Overview
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Brief Summary
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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 problems than cognitive-behavioral therapy alone.

Detailed Description
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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. Based on positive results of a small pilot study it is expected that enriching CBT programs with emotion regulation techniques improves treatment outcome. The primary goal of the proposed project is therefore to evaluate this hypothesis in a randomized design. Patients will be primarily recruited via referrals by primary care doctors. After a screening phase a baseline assessments with different self- and clinician-rating scales (see Outcome Measures) follows. If participants fulfill the eligibility criteria they will be randomized to one of the two study arms: cognitive-behavioral therapy vs. cognitive-behavioral therapy enriched with emotion regulation strategies. After every therapy session patients will be screened in regard to aspects of therapeutic alliance, adverse events, and symptom intensity/annoyance. The post assessment takes place after the 20th session and a follow-up is planned six months after post treatment. Different methods will be applied to prevent bias and to assure a high quality level of the current study. Data handling, data monitoring and statistical analyses will be supervised by the Coordinating Center for Clinical Trials (KKS) of Philipps-University of Marburg; data quality and safety principles will be applied. Additionally an independent Data Safety Monitoring Board will be nominated. The study center will visit all study sites regularly to verify correct procedures, data sampling, and data management. Randomisation occurs and is controlled centrally through the randomisation's central office in KKS Marburg. Furthermore the current study constitutes a single-blinded trial. Assessment interviews are conducted and analyzed by people blinded to the treatment condition. Additionally, treatments are manualized, and therapists receive an intense training. Treatment fidelity/integrity is analyzed with rating schemes for 5% randomly selected videotaped treatment sessions. Allowed additional treatments during study inclusion are thoroughly monitored and analyzed. The sample size calculation is 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, meta-analytic 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 20%, N=244 patients are to be recruited. As main efficacy analysis the primary outcome shall be analyzed with linear mixed-effect models. It will be done according to the Intention-to-Treat (ITT) principle: to consider missing values as a potential source of bias, they will be handled according to the framework by Rubin. Secondary statistical analyses focus on establishing longer term treatment efficacy and describing the pattern of change. For this purpose the mean response will be modeled as a function of time with a separate mixed effects linear model over all assessments. Furthermore, interindividual differences in intraindividual change will be modeled using multilevel analysis for longitudinal data. 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.

Official Title
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Enriching Cognitive-Behavioral Therapy With Emotion Regulation Training in Patients With Chronic Multiple Somatoform Symptoms (ENCERT): A Randomized Controlled Trial

Conditions
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Somatic Symptom Disorder (DSM-V)

Intervention / Treatment
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* Behavioral: Cognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptoms
* Behavioral: Cognitive-behavioral therapy for patients with multiple somatoform symptoms


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ENCERT<br>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 non-judgmental 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<br>* Cognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptoms: 20 weekly sessions individual therapy (à 50) minutes<br>|
| Active Comparator: CBT<br>This arm is based on traditional 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<br>* Cognitive-behavioral therapy for patients with multiple somatoform symptoms: 20 weekly sessions individual therapy (à 50) minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in somatic symptom severity (Screening of Somatoform Disorders, SOMS-7T) from pre-assessment to four in-between assessments to post-assessment to follow-up | Assessment of somatic symptom severity during the last 7 days (self-rating) | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depressive symptoms (Beck Depression Inventory-II, BDI-II) from pre-assessment to one in-between assessment to post-assessment to follow-up | Assessment of depressive symptoms (self-rating) | 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) | 
| Change in emotion regulation skills (Emotion Regulation Skills Questionnaire, ERSQ) from pre-assessment to one in-between assessment to post-assessment to follow-up | Assessment of emotion regulation skills (self-rating) | 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) | 
| Change in symptom-focussed coping strategies (Pain Coping Questionnaire, FESV; Geissner, 2003) from pre-assessment to one in-between assessment to post-assessment to follow-up | Assessment of symptom-focused coping strategies (self-rating) | 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) | 
| Change in general psychopathological symptoms (Symptom Checklist-90, SCL-90) from pre-assessment to one in-between assessment to post-assessment to follow-up | Assessment of general psychopathological symptoms (self-rating) | 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) | 
| Change in symptom-caused disability (Pain Disability Index, PDI) from pre-assessment to one in-between assessment to post-assessment to follow-up | Assessment of symptom-caused disability in different areas of life (self-rating) | 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) | 
| 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 | Assessment of health-related quality of life (self-rating) | 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) | 
| Change in health anxiety (Whiteley Index, WI) from pre-assessment to one in-between assessment to post-assessment to follow-up | Assessment of health anxiety (self-rating) | 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) | 
| 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 | Observer-based assessment of scores for social competence, emotion regulation, relaxation abilities, stress management, etc., in different areas of life (job, family, leisure) | From pre-assessment (admission) to post-assessment (25 weeks after admission) to follow-up (12 months after admission) | 
| Change in health care utilization and indirect costs (Structured Interview for the Assessment of Health Care Utilization, HCU) from pre-assessment to follow-up | Observer-based assessment of HCU and indirect costs. HCU will be transformed to costs using health economy tables | From pre-assessment (admission) to follow-up (12 months after admission) | 
| Inventory of the Assessment of Negative Effects of Psychotherapy (INEP) at post-assessment | Assessment of psychotherapy-induced side effects (self-rating) | Post-assessment (25 weeks after admission) | 
| Inventory of the Assessment of Negative Effects of Psychotherapy (INEP) at follow-up | Assessment of psychotherapy-induced side effects (self-rating) | Follow-up (12 months after admission) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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somatoform symptoms, somatic symptoms, somatoform disorder, somatic symptom disorder, cognitive-behavioral therapy, emotion regulation training