Coping with non-cardiac chest pain: A randomised clinical trial to evaluate a short psychoeducational interventio

Not Applicable

• Conditions: on-cardiac chest pain; F45.3; Somatoform autonomic dysfunction

• Registration Number: DRKS00003545
• Lead Sponsor: niversität Erlangen-Nürnberg, Universitätsklinikum Erlangen, Psychosomatische und Psychotherapeutische Abteilung: Psychotherapieforschung

Brief Summary

Despite medical reassurance, non-cardiac chest pain (NCCP) frequently persists. Psychological interventions seem promising, but single-session interventions (SSI) are under-studied. To analyze the efficacy of a SSI focusing on chest pain perceptions in a randomized controlled trial (RCT), and to identify predictors of pain persistence. Individuals presenting with NCCP to a cardiology unit were randomly assigned to SSI (N = 54) or treatment as usual (N = 59). Follow-up assessments were 1 month (FU1) and 6 months (FU2) later. Primary outcome measures were chest pain (German Pain Questionnaire) and chest pain perceptions (IPQ-B, Reassurance Scale). Two by Three ANOVAs revealed significant improvements over time, but against expectation no significant interaction with group. Health concern and cardiac attribution following cardiac testing predicted FU2 chest pain (p’s .018). These predictors could serve as markers to identify individuals with a risk for persisting complaints, a group that may benefit from interventions addressing dysfunctional illness perceptions.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-15
• Study Completion: 2013-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

chest pain of relevant concern
- the patient experiences the chest pain as distressing
- at least one pain episode during the past 4 weeks
- exclusion of a serious heart disease by cardiac angiography (invasive angiography or CT angiography), i.e. maximum stenosis of < 50 %

Exclusion Criteria

- insufficient German language skills, reading skills or understanding of the study task
- serious cardiac disease (e.g. CAD with at least one stenosis = 50%, myocardial infarction, cardiac insufficiency NYHA III and IV, heart transplantation, documented arrhythmia that had entailed treatment by cardioversion, ablation, cardiac pace maker or implanted defibrillator, cardiomyopathy, anomalies of the heart valve)
- current psychotherapeutic treatment because of chest pain

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Chest pain characteristics (Pain Questionnaire of the German Pain Society). <br><br>2. Subjective Illness Perceptions (Donkin-Scale, IPQ-Brief). <br><br>Assessments were done prior to the intervention as well as 4 week and 6 months following the intervention.

Secondary Outcome Measures

Name	Time	Method
1. Cognitive-perceptual factors (Somatosensory Amplification Scale, Anxiety Sensitivity Index-3, Fragebogen zu Körper und Gesundheit).<br><br>2. Emotional-affective factors (Beck Anxiety Inventar, Patient Health Questionnaire-9).<br><br>3. Behavioural factors (use of medical ressources and medication, International Physical Activity Questionnaire). <br><br>Assessments were done prior to the intervention as well as 4 week and 6 months following the intervention.<br>