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 chest pain (NCCP) is a common diagnosis among patients visiting an
emergency department. In 50-90% of cases, patients presenting to the emergency
department with a chief complaint of chest pain are diagnosed with non-cardiac
chest pain (1, 2). After exclusion a cardiac cause of the symptoms, patients
with chest pain are usually reassured and discharged from the emergency
department. More than half of these patients continue to report chest pain and
remain concerned about having a serious heart disease (3, 4) resulting in high
medical care utilization (5). One of the causes or precipitating factors of
NCCP may be an underlying psychiatric illness such as an anxiety disorder or
mood disorder.
High prevalence rates of psychiatric symptoms have been reported in patients
with chest pain or palpitations (6, 7, 8, 2, 9). These symptoms are most
frequently caused by a panic disorder (PD). This can be due to the tendency of
individuals with PD to focus on the physical symptoms, which they interpret as
dangerous and needing immediate medical care. A panic disorder is rarely
diagnosed after medical evaluation by emergency physicians (9, 6). Without
timely treatment, PD tends to have a chronic course (10, 11), leading to
repeated utilization of emergency departments (12, 13, 14), and high medical
and societal costs (15). This highlights the importance of rapid intervention.
Few studies have described a cognitive behavioural intervention in this patient
group. In Canada, a three-arm randomized controlled trial was performed among
58 NCCP patients presenting at the emergency department. Seven sessions of
cognitive behavioural therapy (CBT) were compared to a short panic management
intervention and treatment as usual (12, 16). The primary outcome was a
reduction in panic symptoms. Both interventions led to greater improvements
panic disorder severity compared to treatment as usual. There was no
significant difference between the seven sessions CBT and the one-session
management intervention.
In the Netherlands, a study compared six sessions of CBT with treatment as
usual (to be reassured by their cardiologist that their complaints were not
caused by cardiac disease). in 113 NCCP patients presenting at the cardiac
emergency unit (17). The primary outcome measure was the clinical global
inventory (CGI). They concluded that CBT was superior to treatment as usual.
Similar results were reported in a study in the Unites States (18). Another
study examined the effect of providing an information leaflet compared to
standard verbal advice in a randomized clinical trial with 700 NCCP patients
(19). Outcome measures were the HADS and SF-36. Providing the leaflet resulted
in significant improvement in anxiety and depressive symptoms.
In summary, several interventions have proven to be effective for treating
panic symptoms in patients with NCCP. The advantage of a leaflet over a short
cognitive behavioural intervention is that it does not require any specialized
training or extra personnel and is less time consuming However no trial has
compared the difference in efficacy of these two interventions. The objective
of our study is to examine the effectiveness of CBT compared to providing an
information leaflet on anxiety and depressive symptoms after four weeks in
patients presenting at an emergency unit with non cardiac chest pain with
comorbid panic symptoms.

The objective of our study is to examine the effectiveness of a cognitive
behavioural therapy based intervention compared to an information leaflet on
anxiety symptoms after one month, in patients presenting at the emergency unit
with non-cardiac chest pain.

This study is a single-center randomized clinical trial. All adult (>=18 years)
patients presenting at the emergency department of the Onze Lieve Vrouwe
Gasthuis with non-cardiac chest pain during a 3-month period (April 2014 to
August 2014) are eligible to enrol. An emergency physician must have excluded
clear somatic causes of the chest symptoms. All patients will complete a
Hospital Anxiety and Depression Rating Scale (HADS) during consultation. This
questionnaire will be administered as part of standard care. The nurse
practitioner will be present and can be contacted by the patient during the
stay at the ED for further information and help. The HADS is frequently used in
consultation and liaison psychiatry in similar studies. Patients who score
above the cut-off score of 8 in the anxiety part of the questionnaire will be
eligible for the study.
Eligible patients will be asked to enroll and handed over the informed consent
letter by their treating emergency physician. Participating patients are
randomized with an off site computer program during their stay at the emergency
room after written informed consent. Usual care has traditionally consisted of
reassurance that the patient has no cardiac disease causing the chest pain and
discharge to care as needed through the patient*s primary care physician (PCP).
Because previous studies show significant effects of both our interventions
[ref], we decided not to develop a control group with treatment as usual.
Patients are randomised for either the leaflet group, or the cognitive based
therapy intervention group. The patients who are randomised for the
leaflet-group, receive the leaflet with an explanation of the treating nurse at
the emergency room. Patients who are randomised for the cognitive therapy based
intervention will be scheduled the next day for the cognitive based
intervention within two weeks after their emergency visit. This intervention
will be performed by one of the hospital psychologists within two weeks of the
emergency room visit. All participating patients will be contacted by telephone
the next weekday by one of the research assistants. During this phone call
participants will be screened with a subset of the MINI. This 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 mood and anxiety disorders in this population. One month after
the emergency department visit, an independent research assistant (not informed
about randomisation, patient characteristics and previous score) will call all
enrolled participants to collect data for the HADS-anxiety score, their health
care use by the TIC-P and the clinical global inventory.

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
of education on the relation of panic complaints and somatic symptoms and
includes a short exposure exercise. The session is described in detail in
attachment A

3.2 Leaflet
The information leaflet contains psycho-educational elements. It explains the
pathway in which anxiety causes somatic symptoms: how this can mimic a heart
attack and gives information about epidemiology, symptoms and treatment of a
panic disorder. The content of this leaflet is based on a previous study (19),
the Dutch guideline for panic disorder, the patient information folder of the
Dutch Psychiatric Association and several informative websites (see attachment
B).

Not applicable