TY - JOUR

T1 - The heart & mind trial

T2 - Intervention with cognitive-behavioural therapy in patients with cardiac disease and anxiety: Randomised controlled trial protocol

AU - Berg, Selina Kikkenborg

AU - Herning, Margrethe

AU - Schjodt, Inge

AU - Thorup, Charlotte Brun

AU - Juul, Carsten

AU - Svendsen, Jesper Hastrup

AU - Jorgensen, Martin Balslev

AU - Risom, Signe Stelling

AU - Christensen, Signe Westh

AU - Thygesen, Lau

AU - Rasmussen, Trine Bernholdt

N1 - Publisher Copyright: © BMJ Publishing Group Limited 2021.

PY - 2021

Y1 - 2021

N2 - Introduction Patients with cardiac disease often experience anxiety (prevalence about 20%-25%) and have a doubled mortality risk when suffering from anxiety compared with patients without anxiety. This calls for interventions aiming to reduce anxiety. Methods and analysis The Heart Mind Trial consists of three parts: (1) screening of all hospitalised and outpatient cardiac patients with arrhythmia, heart failure or ischaemic heart disease at four university hospitals in Denmark using the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A); Patients scoring ≥8 is invited to participate; (2) Assessment of the type of anxiety by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders and (3) Randomised clinical superiority trial with blinded outcome assessment, with 1:1 randomisation to cognitive-behavioural therapy (CBT) performed by a CBT-trained cardiac nurse plus usual care or, usual care alone. The primary outcome is anxiety measured with HADS-A at 5 months. Secondary outcomes include anxiety symptoms measured with Becks Anxiety Inventory and heart rate variability. Exploratory outcomes measured at 12 months include blood cortisol (stress response), blood C reactive protein (stress response), health-related quality of life, readmission, mortality and attributable direct costs. A total of 336 patients will be included. The primary analyses are based on the intention-to-treat principle. For the primary outcome, we will use a linear regression model. For the long-term outcomes, mixed regression models will be used including repeated measurements. Ethics and dissemination The trial is performed in accordance with the Declaration of Helsinki. All patients must give informed consent prior to participation and the trial is initiated after approval by the Danish Data Protection Agency (P-2020-894) and the National Committee on Health Research Ethics (H-20066739). Positive, neutral and negative results of the trial will be published. Trial registration number NCT04582734.

AB - Introduction Patients with cardiac disease often experience anxiety (prevalence about 20%-25%) and have a doubled mortality risk when suffering from anxiety compared with patients without anxiety. This calls for interventions aiming to reduce anxiety. Methods and analysis The Heart Mind Trial consists of three parts: (1) screening of all hospitalised and outpatient cardiac patients with arrhythmia, heart failure or ischaemic heart disease at four university hospitals in Denmark using the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A); Patients scoring ≥8 is invited to participate; (2) Assessment of the type of anxiety by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders and (3) Randomised clinical superiority trial with blinded outcome assessment, with 1:1 randomisation to cognitive-behavioural therapy (CBT) performed by a CBT-trained cardiac nurse plus usual care or, usual care alone. The primary outcome is anxiety measured with HADS-A at 5 months. Secondary outcomes include anxiety symptoms measured with Becks Anxiety Inventory and heart rate variability. Exploratory outcomes measured at 12 months include blood cortisol (stress response), blood C reactive protein (stress response), health-related quality of life, readmission, mortality and attributable direct costs. A total of 336 patients will be included. The primary analyses are based on the intention-to-treat principle. For the primary outcome, we will use a linear regression model. For the long-term outcomes, mixed regression models will be used including repeated measurements. Ethics and dissemination The trial is performed in accordance with the Declaration of Helsinki. All patients must give informed consent prior to participation and the trial is initiated after approval by the Danish Data Protection Agency (P-2020-894) and the National Committee on Health Research Ethics (H-20066739). Positive, neutral and negative results of the trial will be published. Trial registration number NCT04582734.

KW - anxiety disorders

KW - cardiology

KW - mental health

U2 - 10.1136/bmjopen-2021-057085

DO - 10.1136/bmjopen-2021-057085

M3 - Journal article

C2 - 34862302

AN - SCOPUS:85121275323

VL - 11

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 12

M1 - e057085

ER -