Supporting Methods in Cardiovascular Diseases Rehabilitation

Wroclaw University of Health and Sport Sciences

Status: Completed

Conditions: Depressive Symptoms; Coronary Artery Disease; Cardiovascular Diseases; Anxiety; Mood Disorders; Stress

Treatments: Behavioral: Cardiac rehabilitation; Device: Virtual reality therapy; Behavioral: Relaxation-therapeutic recordings; Behavioral: Schultz Autogenic Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06241534

RCT/CR/01/2023

Details and patient eligibility

About

The study evaluates how various therapeutic approaches perform in addressing depression, anxiety symptoms, and stress levels among patients in the second stage of cardiac rehabilitation. This study aims to evaluate the influence of the used therapeutic approaches on psychological outcomes and to compare the effectiveness of these therapies.

Full description

Depression, anxiety, and high levels of perceived stress are increasingly common problems associated with cardiovascular disease (CVD). The relationship between anxiety-depressive disorders and the risk of CVD is confirmed by behavioral and physiological mechanisms. According to the American Heart Association, depression is a negative prognostic factor at all stages of treatment of CVD. The most important risks in people with CVD and anxiety-depressive disorders, as comorbidities, are an increased risk of recurrent cardiovascular events and increased mortality. However, psychological disorders in patients with CVD are still not sufficiently diagnosed and, consequently, are not adequately treated. Therefore, it is necessary to look for effective methods to support cardiac rehabilitation from a psychological perspective.

The first group of patients will receive relaxation-therapeutic recordings (referred to as the Recording Group) in addition to monitored cardiac physical training. The second group will receive virtual reality (VR) therapy (referred to as the VR Group) alongside monitored cardiac physical training. The third group (referred to as the Control Group) will receive Schultz Autogenic Training as a standard supplement to cardiological training.

The aims of the study:

1. The evaluation of the influence of relaxation-therapeutic recordings on the anxiety-depressive symptoms and the stress level of the patients undergoing second stage of cardiac rehabilitation.
2. The comparison of the effectiveness of therapeutic recordings with the effectiveness of VR therapy and Schultz Autogenic Training.

Enrollment: 45 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Coronary Artery Disease;
• the second stage of cardiac rehabilitation conducted in outpatient settings

Exclusion criteria

• inability to self-complete the research questionnaires;
• presence of the following issues at the time of the examination or in the medical data: disturbances of consciousness, psychotic symptoms or other serious psychiatric disorders;
• initiation of psychiatric treatment during the research project;
• contraindications for virtual therapy (epilepsy, vertigo, eyesight impairment);
• the patient's refusal at any stage of the research project.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Recordings Group

Experimental group

Description:

Cardiac rehabilitation supplemented by relaxation-therapeutic recordings

Treatment:

Behavioral: Relaxation-therapeutic recordings

Behavioral: Cardiac rehabilitation

VR Group

Experimental group

Description:

Cardiac rehabilitation supplemented by VR therapy

Treatment:

Device: Virtual reality therapy

Behavioral: Cardiac rehabilitation

Control Group

Active Comparator group

Description:

Cardiac rehabilitation supplemented by Schultz Autogenic Training

Treatment:

Behavioral: Schultz Autogenic Training

Behavioral: Cardiac rehabilitation