Skip to content

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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00017099
Enrollment
40
Registered
2019-10-02
Start date
2019-04-19
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Somatic Symptom Disorder (DSM-5) F45.1

Interventions

Group 1: intervention group – receives an HRV biofeedback training over 4 weeks including one session weekly Group 2: control group – receives autogenic training over 4 weeks including one session wee

Sponsors

Bergische Universität Wuppertal
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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) Assessment is carried out for the HRV and NRS every session, and for the SOMS-7 before and after the intervention.

Secondary

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

Countries

Germany

Contacts

Public ContactLaura Klewinghaus

Bergische Universität Wuppertal Klinische Psychologie und Psychotherapie

klewinghaus@uni-wuppertal.de+492024395051

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 11, 2026