Efficacy of relaxation techniques in somatic symptom disorder” – A randomized- controlled pilot trial on the effects of heart rate variability biofeedback

Phase 2

• Conditions: Somatic Symptom Disorder (DSM-5); F45.1; Undifferentiated somatoform disorder

• Registration Number: DRKS00017099
• Lead Sponsor: Bergische Universität Wuppertal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-02
• Study Completion: 2021-10-04
• Results First Posted: 2022-03-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

primary diagnosis somatic symptom disorder
age between 18 and 65 years
a minimum PHQ-15 score of 5

Exclusion Criteria

Pacemaker
No stable medication
Acute heart disease (e.g. myocarditis)
Diabetes
rheumatism

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impairment due to the somatic symptoms (Screening für somatoforme Störungen (SOMS-7), numeric rating scale (NRS) for symptom intensity and symptom interference and HRV by ECG (bio-feedback-device Nexus-4)<br>Assessment is carried out for the HRV and NRS every session, and for the SOMS-7 before and after the intervention.

Secondary Outcome Measures

Name	Time	Method
1.SSD symptomatology by use of questionnaires:<br>Somatic Symptom Disorder 12 (SSD-12)<br>Pain Disability Questionnaire (PDI)<br>Numeric rating scale for subjective controllability and health concerns (NRS-C, NRS-HC)<br><br>2.General psychopathology: <br>Depressive symptoms by use of Patient Health Questionnaire (PHQ-9) and anxiety symptoms by use of Generalized Anxiety Disorder Scale (GAD-7)<br>Emotionregulation strategies by use of the Heidelberger Fragebogen für Emotionsregulation (H-Ferst)<br>Interoception by 2 subscales (noticing and attention regulation) of the Multidimen-sional Assessment of Interoceptive Awareness (MAIA)<br>Internal control beliefs (KKG-I, specific for relaxation)<br><br>3.Credibility and expectancy by use of the Credibility and Expectancy questionnaire (CEQ)<br><br>4.Further instruments: general evaluation questionnaire