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

NCT01908855 | Completed DMC

• 2 other identifiers: ENCERT-130313Ri 574/24-1
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 7

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.

Conditions

Somatic Symptom Disorder (DSM-V)

Keywords

somatoform symptoms; somatic symptoms; somatoform disorder; somatic symptom disorder; cognitive-behavioral therapy; emotion regulation training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change in depressive symptoms (Beck Depression Inventory-II, BDI-II) from pre-assessment to one in-between assessment to post-assessment to follow-up

  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

  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

  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

  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

  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)

Study Arms (2)

ENCERT

EXPERIMENTAL

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

CBT

ACTIVE COMPARATOR

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

Interventions

Cognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptoms BEHAVIORAL

Cognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptoms: 20 weekly sessions individual therapy (à 50) minutes

ENCERT

Cognitive-behavioral therapy for patients with multiple somatoform symptoms BEHAVIORAL

Cognitive-behavioral therapy for patients with multiple somatoform symptoms: 20 weekly sessions individual therapy (à 50) minutes

CBT

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philipps University Marburg: lead
• University of Technology Munich: collaborator
• Central Institute of Mental Health, Mannheim: collaborator
• University of Giessen: collaborator
• University of Wuppertal: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• University of Kaiserslautern-Landau: collaborator
• German Research Foundation: collaborator
• Philipps University Marburg Coordination Centre for Clinical Trials: collaborator

Study Sites (7)

Justus-Liebig-University, CBT Outpatient Clinic

Giessen, D-35394, Germany

Location

University Medical Center Hamburg-Eppendorf, Department of Psychosomatic Medicine

Hamburg, D-20246, Germany

Location

University Koblenz-Landau, Department of Clinical Psychology and Psychotherapy

Koblenz-Landau, D-76829, Germany

Location

Central Institute of Mental Health, Department of Clinical Psychology

Mannheim, D-68159, Germany

Location

Philipps-University, Department of Clinical Psychology and Psychotherapy

Marburg, D-35032, Germany

Location

Rechts der Isar Hospital, University of Technology, Department of Psychosomatic Medicine and Psychotherapy

München, D-81675, Germany

Location

Bergische University, Department of Clinical Psychology and Psychotherapy

Wuppertal, D-42097, Germany

Location

Related Publications (17)

• Barsky AJ, Orav EJ, Bates DW. Somatization increases medical utilization and costs independent of psychiatric and medical comorbidity. Arch Gen Psychiatry. 2005 Aug;62(8):903-10. doi: 10.1001/archpsyc.62.8.903.

  PMID: 16061768 BACKGROUND

• Geissner E. Pain Coping Questionnaire FESV. Göttingen, Germany: Hogrefe; 2003.

  BACKGROUND

• Göllner R, Gollwitzer M, Heider J, Zaby A, Schröder A. Analyzing longitudinal data with hierarchical linear models. Zeitschrift für Klinische Psychologie und Psychotherapie 39(3):179-88, 2010.

  BACKGROUND

• Gottschalk JM, Bleichhardt G, Kleinstäuber M, Berking M, Rief W. Treatment efficacy of multiple somatoform symptoms? Enriching cognitive behavioral therapy with emotion regulation training: Results of a controlled pilot study. In preparation.

  BACKGROUND

• Jacobi F, Wittchen H-U, Holting C, Hofler M, Pfister H, Muller N, Lieb R. Prevalence, co-morbidity and correlates of mental disorders in the general population: results from the German Health Interview and Examination Survey (GHS). Psychol Med. 2004 May;34(4):597-611. doi: 10.1017/S0033291703001399.

  PMID: 15099415 BACKGROUND

• Kleinstauber M, Witthoft M, Hiller W. Efficacy of short-term psychotherapy for multiple medically unexplained physical symptoms: a meta-analysis. Clin Psychol Rev. 2011 Feb;31(1):146-60. doi: 10.1016/j.cpr.2010.09.001. Epub 2010 Sep 16.

  PMID: 20920834 BACKGROUND

• Kroenke K. Efficacy of treatment for somatoform disorders: a review of randomized controlled trials. Psychosom Med. 2007 Dec;69(9):881-8. doi: 10.1097/PSY.0b013e31815b00c4.

  PMID: 18040099 BACKGROUND

• Molenberghs G, Kenward MG.Missing Data in Clinical Studies. Chichester, UK: Whiley; 2007.

  BACKGROUND

• Moscovitch DA, Hofmann SG, Suvak MK, In-Albon T. Mediation of changes in anxiety and depression during treatment of social phobia. J Consult Clin Psychol. 2005 Oct;73(5):945-952. doi: 10.1037/0022-006X.73.5.945.

  PMID: 16287394 BACKGROUND

• Rief W, Hiller W. A new approach to the assessment of the treatment effects of somatoform disorders. Psychosomatics. 2003 Nov-Dec;44(6):492-8. doi: 10.1176/appi.psy.44.6.492.

  PMID: 14597684 BACKGROUND

• Rief W, Rojas G. Stability of somatoform symptoms--implications for classification. Psychosom Med. 2007 Dec;69(9):864-9. doi: 10.1097/PSY.0b013e31815b006e.

  PMID: 18040096 BACKGROUND

• Rieffe C, Terwogt MM, Bosch JD, Kneepkens CMF, Douwes AC, Jellesma FC. Interaction between emotions and somatic complaints in children who did or did not seek medical care. Cognition Emotion 21(8):1630-1646, 2007.

  BACKGROUND

• Waller E, Scheidt CE. Somatoform disorders as disorders of affect regulation: a study comparing the TAS-20 with non-self-report measures of alexithymia. J Psychosom Res. 2004 Sep;57(3):239-47. doi: 10.1016/S0022-3999(03)00613-5.

  PMID: 15507250 BACKGROUND

• Witthoft M, Rist F, Bailer J. Abnormalities in cognitive-emotional information processing in idiopathic environmental intolerance and somatoform disorders. J Behav Ther Exp Psychiatry. 2009 Mar;40(1):70-84. doi: 10.1016/j.jbtep.2008.04.002. Epub 2008 May 23.

  PMID: 18501333 BACKGROUND

• Senger K, Rubel JA, Kleinstauber M, Schroder A, Kock K, Lambert MJ, Lutz W, Heider J. Symptom change trajectories in patients with persistent somatic symptoms and their association to long-term treatment outcome. Psychother Res. 2022 Jun;32(5):624-639. doi: 10.1080/10503307.2021.1993376. Epub 2021 Oct 29.

  PMID: 34711141 DERIVED

• Schwarz J, Rief W, Radkovsky A, Berking M, Kleinstauber M. Negative affect as mediator between emotion regulation and medically unexplained symptoms. J Psychosom Res. 2017 Oct;101:114-121. doi: 10.1016/j.jpsychores.2017.08.010. Epub 2017 Aug 10.

  PMID: 28867416 DERIVED

• Kleinstauber M, Gottschalk J, Berking M, Rau J, Rief W. Enriching Cognitive Behavior Therapy with Emotion Regulation Training for Patients with Multiple Medically Unexplained Symptoms (ENCERT): Design and implementation of a multicenter, randomized, active-controlled trial. Contemp Clin Trials. 2016 Mar;47:54-63. doi: 10.1016/j.cct.2015.12.003. Epub 2015 Dec 4.

  PMID: 26655432 DERIVED

MeSH Terms

Conditions

Medically Unexplained Symptoms; Somatoform Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Winfried Rief, Ph.D.

  Philipps University Marburg

  PRINCIPAL INVESTIGATOR

• Mathias Berking, Ph.D.

  Philipps University Marburg

  STUDY CHAIR

• Maria Kleinstäuber, Ph.D.

  Philipps University Marburg

  STUDY CHAIR

• Japhia-Maria Gottschalk, M.Sc.

  Philipps University Marburg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychology

Study Record Dates

• First Submitted: July 19, 2013
• First Posted: July 26, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: March 1, 2017
• Last Updated: August 11, 2017

Record last verified: 2017-08

Locations

DE (7)