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

Primary Purpose

Somatic Symptom Disorder (DSM-V)

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptoms
Cognitive-behavioral therapy for patients with multiple somatoform symptoms
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Somatic Symptom Disorder (DSM-V) focused on measuring somatoform symptoms, somatic symptoms, somatoform disorder, somatic symptom disorder, cognitive-behavioral therapy, emotion regulation training

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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):

    1. Disproportionate and persistent thoughts about the seriousness of one's symptoms
    2. Persistently high level of anxiety about health or symptoms
    3. 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

  • Justus-Liebig-University, CBT Outpatient Clinic
  • University Medical Center Hamburg-Eppendorf, Department of Psychosomatic Medicine
  • University Koblenz-Landau, Department of Clinical Psychology and Psychotherapy
  • Central Institute of Mental Health, Department of Clinical Psychology
  • Philipps-University, Department of Clinical Psychology and Psychotherapy
  • Rechts der Isar Hospital, University of Technology, Department of Psychosomatic Medicine and Psychotherapy
  • Bergische University, Department of Clinical Psychology and Psychotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ENCERT

CBT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

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
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
Assessment of emotion regulation skills (self-rating)
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)
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)
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)
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)
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)
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)
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
Inventory of the Assessment of Negative Effects of Psychotherapy (INEP) at post-assessment
Assessment of psychotherapy-induced side effects (self-rating)
Inventory of the Assessment of Negative Effects of Psychotherapy (INEP) at follow-up
Assessment of psychotherapy-induced side effects (self-rating)

Full Information

First Posted
July 19, 2013
Last Updated
August 9, 2017
Sponsor
Philipps University Marburg Medical Center
Collaborators
University of Technology Munich, Central Institute of Mental Health, Mannheim, University of Giessen, University of Wuppertal, Universitätsklinikum Hamburg-Eppendorf, University of Kaiserslautern-Landau, German Research Foundation, Philipps University Marburg Coordination Centre for Clinical Trials
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1. Study Identification

Unique Protocol Identification Number
NCT01908855
Brief Title
Cognitive-Behavioral Therapy Enriched With Emotion Regulation Training for Multiple Somatoform Symptoms
Acronym
ENCERT
Official Title
Enriching Cognitive-Behavioral Therapy With Emotion Regulation Training in Patients With Chronic Multiple Somatoform Symptoms (ENCERT): A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philipps University Marburg Medical Center
Collaborators
University of Technology Munich, Central Institute of Mental Health, Mannheim, University of Giessen, University of Wuppertal, Universitätsklinikum Hamburg-Eppendorf, University of Kaiserslautern-Landau, German Research Foundation, Philipps University Marburg Coordination Centre for Clinical Trials

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 problems than cognitive-behavioral therapy alone.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Somatic Symptom Disorder (DSM-V)
Keywords
somatoform symptoms, somatic symptoms, somatoform disorder, somatic symptom disorder, cognitive-behavioral therapy, emotion regulation training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ENCERT
Arm Type
Experimental
Arm Description
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.
Arm Title
CBT
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptoms
Intervention Description
Cognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptoms: 20 weekly sessions individual therapy (à 50) minutes
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy for patients with multiple somatoform symptoms
Intervention Description
Cognitive-behavioral therapy for patients with multiple somatoform symptoms: 20 weekly sessions individual therapy (à 50) minutes
Primary Outcome Measure Information:
Title
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
Description
Assessment of somatic symptom severity during the last 7 days (self-rating)
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)
Secondary Outcome Measure Information:
Title
Change in depressive symptoms (Beck Depression Inventory-II, BDI-II) from pre-assessment to one in-between assessment to post-assessment to follow-up
Description
Assessment of depressive symptoms (self-rating)
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)
Title
Change in emotion regulation skills (Emotion Regulation Skills Questionnaire, ERSQ) from pre-assessment to one in-between assessment to post-assessment to follow-up
Description
Assessment of emotion regulation skills (self-rating)
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)
Title
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
Description
Assessment of symptom-focused coping strategies (self-rating)
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)
Title
Change in general psychopathological symptoms (Symptom Checklist-90, SCL-90) from pre-assessment to one in-between assessment to post-assessment to follow-up
Description
Assessment of general psychopathological symptoms (self-rating)
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)
Title
Change in symptom-caused disability (Pain Disability Index, PDI) from pre-assessment to one in-between assessment to post-assessment to follow-up
Description
Assessment of symptom-caused disability in different areas of life (self-rating)
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)
Title
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
Description
Assessment of health-related quality of life (self-rating)
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)
Title
Change in health anxiety (Whiteley Index, WI) from pre-assessment to one in-between assessment to post-assessment to follow-up
Description
Assessment of health anxiety (self-rating)
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)
Title
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
Description
Observer-based assessment of scores for social competence, emotion regulation, relaxation abilities, stress management, etc., in different areas of life (job, family, leisure)
Time Frame
From pre-assessment (admission) to post-assessment (25 weeks after admission) to follow-up (12 months after admission)
Title
Change in health care utilization and indirect costs (Structured Interview for the Assessment of Health Care Utilization, HCU) from pre-assessment to follow-up
Description
Observer-based assessment of HCU and indirect costs. HCU will be transformed to costs using health economy tables
Time Frame
From pre-assessment (admission) to follow-up (12 months after admission)
Title
Inventory of the Assessment of Negative Effects of Psychotherapy (INEP) at post-assessment
Description
Assessment of psychotherapy-induced side effects (self-rating)
Time Frame
Post-assessment (25 weeks after admission)
Title
Inventory of the Assessment of Negative Effects of Psychotherapy (INEP) at follow-up
Description
Assessment of psychotherapy-induced side effects (self-rating)
Time Frame
Follow-up (12 months after admission)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winfried Rief, Ph.D.
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mathias Berking, Ph.D.
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maria Kleinstäuber, Ph.D.
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Japhia-Maria Gottschalk, M.Sc.
Organizational Affiliation
Philipps University Marburg Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Justus-Liebig-University, CBT Outpatient Clinic
City
Gießen
ZIP/Postal Code
D-35394
Country
Germany
Facility Name
University Medical Center Hamburg-Eppendorf, Department of Psychosomatic Medicine
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Facility Name
University Koblenz-Landau, Department of Clinical Psychology and Psychotherapy
City
Koblenz-Landau
ZIP/Postal Code
D-76829
Country
Germany
Facility Name
Central Institute of Mental Health, Department of Clinical Psychology
City
Mannheim
ZIP/Postal Code
D-68159
Country
Germany
Facility Name
Philipps-University, Department of Clinical Psychology and Psychotherapy
City
Marburg
ZIP/Postal Code
D-35032
Country
Germany
Facility Name
Rechts der Isar Hospital, University of Technology, Department of Psychosomatic Medicine and Psychotherapy
City
München
ZIP/Postal Code
D-81675
Country
Germany
Facility Name
Bergische University, Department of Clinical Psychology and Psychotherapy
City
Wuppertal
ZIP/Postal Code
D-42097
Country
Germany

12. IPD Sharing Statement

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

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