CBT Enriched With Emotion Regulation Training for Multiple Somatoform Symptoms (ENCERT) - A 3-year Follow-up

NCT03982524 | Completed DMC

• 2 other identifiers: ENCERT-042017KL 3132/2-4
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether 3 years after the end of therapy cognitive-behavioral therapy complemented with strategies from emotion regulation training leads to better improvement in somatic symptoms and comorbid problems in patients with chronic multiple somatoform symptoms than cognitive behavioral therapy alone.

Conditions

Somatic Symptom Disorder (DSM-5)

Keywords

somatoform symptoms; somatic symptoms; somatoform disorder; somatic symptom disorder; cognitive-behavioral therapy; emotion regulation training; 3-year follow-up

Outcome Measures

Primary Outcomes (1)

• Change in somatic symptom severity (Screening of Somatoform Disorders, SOMS-7T) from pre-assessment to 3-year follow-up

  Assessment of somatic symptom severity during the last 7 days (self-rating)

  From pre-assessment (admission) to follow-up (42 months after admission)

Secondary Outcomes (7)

• Change in depressive symptoms (Beck Depression Inventory-II, BDI-II) from pre-assessment to 3-year follow-up

  From pre-assessment (admission) to follow-up (42 months after admission)

• Change in emotion regulation skills (Emotion Regulation Skills Questionnaire, ERSQ) from pre-assessment to 3-year follow-up

  From pre-assessment (admission) to follow-up (42 months after admission)

• Change in symptom-focused coping strategies (Pain Coping Questionnaire) from pre-assessment to 3-year follow-up

  From pre-assessment (admission) to follow-up (42 months after admission)

• Change in general psychopathological symptoms (Symptom Checklist-90, SCL-90) from pre-assessment to 3-year follow-up

  From pre-assessment (admission) to follow-up (42 months after admission)

• Change in symptom-caused disability (Pain Disability Index, PDI) from pre-assessment to 3-year follow-up

  From pre-assessment (admission) to follow-up (42 months after admission)

Study Arms (2)

CBT complemented with emotion regulation training

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 nonjudgmental 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

Cognitive behavior therapy (CBT)

ACTIVE COMPARATOR

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.

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)

CBT complemented with emotion regulation training

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)

Cognitive behavior therapy (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
• 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

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

Study Sites (1)

Department of Psychology, Philipps University Marburg

Marburg, Hesse, 35032, Germany

Location

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

• Maria Kleinstäuber, PhD

  Philipps University Marburg

  PRINCIPAL INVESTIGATOR

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: SPONSOR

Study Record Dates

• First Submitted: June 8, 2019
• First Posted: June 11, 2019
• Study Start: April 1, 2017
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication; no end date
• Access Criteria: Proposals should be directed to the corresponding author (MK; maria.kleinstaeuber@staff.uni-marburg.de). To gain access, data requestors will need to sign a data access agreement. Data are not publicly available because informed consent provided by participants of this study is committed to a defined purpose.

Locations

DE (1)