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

Not Applicable

Recruiting

Conditions: Chronic primary musculoskeletal pain (ICD-11
MG30.02), somatic symptom disorder (DSM-5)
F45.41

Registration Number: DRKS00031937

Lead Sponsor: ehrstuhl für Klinische Psychologie und Psychotherapie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

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

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 < 17 kg/m²;> 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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).<br><br>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).<br>

Secondary Outcome Measures

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