Anxiety Clinical Trial
Official title:
Screening and Intervention Reducing Anxiety in Patients With Implanted Cardioverter Defibrillator (ICD) - Screen-ICD
The hypothesis is that there is a significant difference in anxiety scores between
intervention and usual care group after intervention.
The aim of this randomised trial is (I) to determine the type of anxiety in ICD patients and
(ii) to investigate the effect of screening followed by randomisation to intervention with
consultations based on cognitive therapeutic principals to reduce anxiety in patients with
ICD or usual care.
Screen-ICD is an investigator-initiated randomised clinical superiority trial with blinded
outcome assessment, including two university hospitals, with 1:1 randomisation to cognitive
therapy plus usual care or usual care alone.
The intervention: all patients receive usual care. Patients in the intervention group will
receive an intervention based on cognitive behavioral therapy. The intervention consists of
three steps: 1. The intervention begins with a consultation with a nurse aiming at uncovering
anxiety using the Hamilton anxiety scale and exploring how life with an ICD is perceived, 2.
Based on the pre-specified protocols for each type of anxiety, cognitive therapy is provided
and 3. After each session participants are asked to fill out the HADS questionnaire. When the
patient scores below the cut-off value two times in a row, sessions will end. Each patient
can have a maximum of 15 sessions.
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