Screening and Intervention Reducing Anxiety in Patients With Cardiac Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cognitive Therapy Anxiety Disorders Heart Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Because of the conditions required for psycho-educational interventions, it is not possible to blind the intervention staff and patients. All baseline information and clinical interviews are collected and performed before randomization. Physical tests, data collection, data management and administration will be done by blinded staff. Statistical analysis of outcomes and conclusions from these will be blinded. Results of the trial are analysed by an independent statistician, and the results will be interpreted by the research group. The conclusion will be prepared in two versions, before the allocation code is broken, with the two arms alternately assumed as intervention (one that assumes that arm A is the intervention, and second, that assumes that the arm B intervention).

Study Groups

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Intervention group - cognitive behavioral therapy

The intervention consists of three parts: 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.The intervention is considered finalized if the patient has a HADS-A score under 8 two times in a row. The intervention group will receive usual care as well.

Group Type EXPERIMENTAL

Cognitive-behavioural therapy

Intervention Type BEHAVIORAL

Cognitive-behavioural therapy intervention

Usual Care group

The usual care group (control group) will receive usual care which consists cardiac disease control and treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive-behavioural therapy

Cognitive-behavioural therapy intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No