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.

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. - Non Cardiac Chestpain or palpitations in the ER (NOCIE).

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41156

Enrollment

200

Registered

2014-05-27

Start date

2014-09-04

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

atypical chest pain panic attack unexplained chest pain

Interventions

3.1 Cognitive therapy based intervention The cognitive therapy based intervention will consist of a single group session of one and a half hour within two weeks of presentation. This session consist

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The main parameter is the (equality in the) decrease of the score on the anxiety part of the hospital depression and anxiety score (HADS-A).	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)