Finding the optimal treatment of severe panic symptoms in patients presenting at the emergency department with non-cardiac chest pain or palpitations. A cognitive behavioural therapy based intervention versus an information sheet. A randomized controlled trial.

Completed

Conditions: atypical chest pain
panic attack
unexplained chest pain
10082206
10002861

Registration Number: NL-OMON41156

Lead Sponsor: Onze Lieve Vrouwe Gasthuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

Patients are included if they present with chest pain or palpitations of possible cardiac origin, and have negative test results for acute coronary syndrome and have no life threatening non-cardiac disease (eg pnemothorax, pneumonia, or cardiac arrhythmia) or traumatic injuries (rib fracture). Other inclusion criteria are 18 years or older and scoring an 8 or higher on the HADS-A, being able to speak the Dutch language and being reachable by telephone. Patients can only be included once during the study period.

Exclusion Criteria

Patients will be excluded from the study if they are already receiving psychiatric or psychological treatment, have current substance dependence or abuse, or suffer from psychosis or severe cognitive dysfunction. Patients who are not able to speak the Dutch language will also be excluded.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main parameter is the (equality in the) decrease of the score on the<br /><br>anxiety part of the hospital depression and anxiety score (HADS-A). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are the use of health care with the TIC-P<br /><br>questionnaire and the Global Cognitive Impression (CGI) scale. A cost<br /><br>minimisation calculation will be performed.<br /><br>The economic evaluation reflects the time window between randomization and 30<br /><br>days after primary ED visit. Costs of distributing a leaflet are compared with<br /><br>those of the single session CGT. The cost analysis will include all real costs<br /><br>for primary visit and visits of health care providers within 30 days. The<br /><br>cumulative costs during this period will be estimated according to registration<br /><br>of volumes and calculation of prices by the Dutch costing guidelines. Direct<br /><br>medical costs and non medical costs will be included in the analysis. All<br /><br>prices will be defined by the year 2014. </p><br>