Screening and Intervention Reducing Anxiety in Patients With Cardiac Disease

  • STATUS
    Recruiting
  • End date
    Dec 29, 2024
  • participants needed
    336
  • sponsor
    Rigshospitalet, Denmark
Updated on 29 December 2021

Summary

The hypothesis is that there is a significant difference in anxiety scores between intervention and usual care group after intervention. The aim of Heart & Mind Trial is (I) to determine the type of anxiety in cardiac patients and (ii) to investigate the effect of individual cognitive behavioural therapeutic intervention to reduce anxiety in patients with cardiac disease and anxiety compared to usual care.

Description

The Heart & Mind Trial is an investigator-initiated randomised clinical superiority trial with blinded outcome assessment, including four 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) screening of hospitalised and outpatient cardiac patients at four university hospitals using the Hospital Anxiety and Depression Scale (HADS), scores ≥8 are invited to participate. (2) Assessment of type of anxiety by Structured Clinical Interview for DSM Disorders (SCID). (3) Investigator-initiated randomised clinical superiority trial with blinded outcome assessment, with 1:1 randomisation to cognitive-behavioural therapy (CBT) performed by a cardiac nurse with (CBT) training, plus usual care or usual care alone.

Details
Condition Cognitive Therapy, Anxiety Disorders, Heart Diseases
Treatment cognitive-behavioural therapy
Clinical Study IdentifierNCT04582734
SponsorRigshospitalet, Denmark
Last Modified on29 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients must be ≥18 years
Diagnosed with cardiac disease
Speak and understand Danish
Score ≥8 on the Hospital Anxiety and Depression Scale - Anxiety (HADS-A)
HADS-A score must exceed the HADS-D score
Gives written informed consent
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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