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Finding the optimal treatment of severe panic symptoms in patients presenting at the emergency department with non-cardiac chest pain or palpitations.


- candidate number20746
- NTR NumberNTR4917
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-okt-2014
- Secondary IDsNL48093.100.14. WO 13.120  VCMO. MEC-OLVG.
- Public TitleFinding the optimal treatment of severe panic symptoms in patients presenting at the emergency department with non-cardiac chest pain or palpitations.
- Scientific TitleFinding 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.
- ACRONYMNOCIE
- hypothesisThe objective is to compare the reduction of panic symptoms and use of health care bewteen a single session cognitive behavioural therapy based intervention to providing an information leaflet directly at the ER, in patients suffering from non-cardiac chest pain with comorbid panic symptoms.
- Healt Condition(s) or Problem(s) studiedAnxiety disorders, Panic disorder, Palpitations, Chest pain
- Inclusion criteriaPatients 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 an age of 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 criteriaPatients 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. Substance abuse can cause panic-like symptoms on a physical level. Psychological treatment might interfere with our test results.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2014
- planned closingdate1-sep-2015
- Target number of participants100
- InterventionsThe 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 of education on the relation of panic complaints and somatic symptoms and includes a short exposure exercise. The information leaflet contains psycho-educational elements about non-cardiac chest pain. It explains the pathway in which anxiety causes somatic symptoms and how this can mimic a heart attack. Is also gives information about epidemiology, symptoms and treatment of panic symptoms.
- Primary outcomeThe 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 outcomeSecondary 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.
- TimepointsInclusion will start at the emergency department where they will as described in the study design. All patients are called the next day by one of the research assistants for the subset of the MINI, which is a short diagnostic structured interview for classifying ICD-10 and DSM –IV psychiatric disorders. It focuses on current disorders and will be used to measure the prevalence of psychiatric disorders in this population. Is will also filter out the seriously ill patients who need immediate psychiatric treatment. If necessary, they will be leaded to care as is usual in our region. One month after the intervention, a second, blinded research assistant will call all enrolled participants to obtain the second HADS-anxiety score, the TIC-P questionnaire and the Global Cognitive Impression (CGI) scale. After two months a third HADS-A will be obtained by a short telephone interview
- Trial web sitehttp://www.trialregister.nl/trialreg/docs/varlijst.asp
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES J. Lijmer
- CONTACT for SCIENTIFIC QUERIES J. Lijmer
- Sponsor/Initiator Onze Lieve Vrouwe Gasthuis (OLVG)
- Funding
(Source(s) of Monetary or Material Support)
None
- PublicationsNone
- Brief summaryRationale: A large proportion of patients presenting with cardiac chest pain or palpitations at an emergency room are suffering form severe panic symptoms. Previous studies have shown that a single cognitive behavioural therapy session or an information sheet can reduce these symptoms. No study has compared these interventions directly Objective: To compare the reduction of panic symptoms after one month of a single session cognitive behavioural therapy based intervention to providing an information leaflet directly at the ER, in patients suffering from non-cardiac chest pain with comorbid panic symptoms.
Study design: Single centre, single-blinded, randomized controlled trial
Study population: Patients older than18 years, presenting at the emergency department of the Onze Lieve Vrouwe Gasthuis in Amsterdam with acute chest pain or palpitations and have negative test results for acute coronary syndrome and have no life threatening non-cardiac disease.
Methods: Patients are included at the emergency room if they are likely to suffer from panic symptoms, by scoring an eight or higher at the HADS-anxiety score. After randomization, one group receives a single cognitive behavioural group session, developed for panic symptoms. The other group receives an information sheet about non-cardiac chest pain after assessment in the emergency room. The day after presentation, participants are interviewed with a MINI, CGI and HADS-A. Use of health care, CGI and HADS-A are evaluated after one month. A second HADS will be performed after two months.
Main study parameters/endpoints: The reduction in panic symptoms measured by the anxiety score of the HADS after four weeks compared to baseline. Secondary outcome measures are the use of health care with the TIC-P questionnaire and the Global Cognitive Impression (CGI) scale.
- Main changes (audit trail)
- RECORD21-okt-2014 - 23-jan-2015


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