Screening and Intervention Reducing Anxiety in Patients With Cardiac Disease

Rigshospitalet

Status: Active, not recruiting

Conditions: Cognitive Therapy; Heart Diseases; Anxiety Disorders

Treatments: Behavioral: Cognitive-behavioural therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04582734

The Heart & Mind Trial

Details and patient eligibility

About

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.

Full 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.

Enrollment: 336 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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336 participants in 2 patient groups

Intervention group - cognitive behavioral therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive-behavioural therapy

Usual Care group

No Intervention group

Description:

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