Effect of a short-term psychotherapy with heart rate variability biofeedback on chronic pain - a pilot study

Effect of a short-term psychotherapy with heart rate variability biofeedback on chronic pain - a pilot study - SchmerzPT

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00031937

Enrollment

Registered

2023-08-15

Start date

2023-12-19

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Chronic primary musculoskeletal pain (ICD-11

Interventions

Group 1: Intervention group- receives a short-term cognitive behavioural therapy with HRV biofeedback during the first half of treatment Group 2: Intervention group- receives a short-term cognitive be

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Chronic musculoskeletal pain for six months + diagnosis of somatic symptom disorder

Exclusion criteria

Exclusion criteria: • Pacemaker • Acute heart disease (e.g. myocarditis) • Diabetes • Rheumatism • Psychotic episodes, current and in medical history • Cardiovascular medication • Dependency disorders (substance-related) • BMI 30 kg/m² • Acquired brain damage • Primary disorders requiring other treatment interventions (e.g., suicidality) • Ongoing psychotherapy • Outpatient cognitive behaviour therapy related to chronic pain within the past 2 years • In case of medication: Change in medication in the period between four weeks prior to treatment initiation and follow-up

Design outcomes

Primary

Measure	Time frame
Pain intensity and interference (Numerical rating scales, NRS), psychological symptoms of somatic symptom disorder (Somatic Symptom Disorder B-Criteria Scale 12; SSD-12) and HRV by ECG (biofeedback device Nexus-4). The primary endpoints will be collected at five different time points (at baseline, at the start of therapy, after sessions 6 and 12, and five weeks after the end of therapy).	—

Secondary

Measure	Time frame
1. General psychopathology • Impairment due to pain (Pain disability index; PDI; Patient Health Questionnaire -15; PHQ-15) • Fear-avoidance beliefs (Pain anxiety symptoms scale, PASS-20-GV) • Perceived control (NRS) • Health anxiety (NRS) • Pain related self efficacy (Fragebogen zur Erfassung der schmerzspezifischen Selbstwirksamkeit; FESS) • Self-efficacy expectations (General self-efficacy scale; GSE) • Depressive symptoms by use of Patient Health Questionnaire (PHQ-9) • Emotion regulation strategies by means of the Heidelberg Questionnaire for Emotion Regulation (H-FERST) • Quality of life (EQ-5D) • Loneliness (ULS-8) 2. Therapy related outcomes • Credibility and expectancy by use of Credibility and Expectancy questionnaire (CEQ) • Working alliance (Working alliance inventory; WAI) 3. Satisfaction with treatment, side effects, acceptance	—

Measure

Time frame

1. General psychopathology • Impairment due to pain (Pain disability index; PDI; Patient Health Questionnaire -15; PHQ-15) • Fear-avoidance beliefs (Pain anxiety symptoms scale, PASS-20-GV) • Perceived control (NRS) • Health anxiety (NRS) • Pain related self efficacy (Fragebogen zur Erfassung der schmerzspezifischen Selbstwirksamkeit; FESS) • Self-efficacy expectations (General self-efficacy scale; GSE) • Depressive symptoms by use of Patient Health Questionnaire (PHQ-9) • Emotion regulation strategies by means of the Heidelberg Questionnaire for Emotion Regulation (H-FERST) • Quality of life (EQ-5D) • Loneliness (ULS-8) 2. Therapy related outcomes • Credibility and expectancy by use of Credibility and Expectancy questionnaire (CEQ) • Working alliance (Working alliance inventory; WAI) 3. Satisfaction with treatment, side effects, acceptance

—

Countries

Germany

Contacts

Public ContactSarah Lirien Wünsche

Lehrstuhl für Klinische Psychologie und Psychotherapie

wuensche@uni-wuppertal.de+49 (0)202 439-5053

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026