Supporting Methods in Cardiovascular Diseases Rehabilitation

Not Applicable

Completed

• Conditions: Depressive Symptoms; Coronary Artery Disease; Cardiovascular Diseases; Anxiety; Mood Disorders; Stress
• Interventions: Behavioral: Cardiac rehabilitation; Behavioral: Relaxation-therapeutic recordings; Device: Virtual reality therapy; Behavioral: Schultz Autogenic Training

• Registration Number: NCT06241534
• Lead Sponsor: Wroclaw University of Health and Sport Sciences

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-01-26
• Study First Submitted QC: 2024-01-26
• Study Start: 2024-02-01
• Study First Posted: 2024-02-05
• Primary Completion: 2024-04-15
• Study Completion: 2024-05-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Recordings Group	Cardiac rehabilitation	Cardiac rehabilitation supplemented by relaxation-therapeutic recordings
VR Group	Cardiac rehabilitation	Cardiac rehabilitation supplemented by VR therapy
Recordings Group	Relaxation-therapeutic recordings	Cardiac rehabilitation supplemented by relaxation-therapeutic recordings
VR Group	Virtual reality therapy	Cardiac rehabilitation supplemented by VR therapy
Control Group	Cardiac rehabilitation	Cardiac rehabilitation supplemented by Schultz Autogenic Training
Control Group	Schultz Autogenic Training	Cardiac rehabilitation supplemented by Schultz Autogenic Training

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale Hospital Anxiety and Depression Scale	15 minutes	The Hospital Anxiety and Depression Scale (HADS) is a fourteen-item scale scoring from 0 to 3 for each item. The first seven items relate to anxiety (HADS-A), and the remaining seven items relate to depression (HADS-D). The global scoring ranges from 0 to 42 with a cut-off point of 8/21 for anxiety and 8/21 for depression. The higher the score, the greater anxiety or depression symptoms. HADS will be performed at the beginning and after four weeks of treatment.
Perception of Stress Questionnaire	20 minutes	The Perception of Stress Questionnaire (PSQ) was created by Plopa and Makarowski. It is a 27-item scale scoring from 1 to 5 points for each item, where 21 items examine the level of stress in the areas of emotional tension, external stress and intrapsychic stress, and six items refer to the lie scale. The global scoring for the perception of stress ranges from 21 to 105, with a cut-off point of 60 for an elevated level of perceived stress. Higher scores indicate higher stress perception.

Trial Locations

Locations (1)

Cardiology Center Pro Corde; 🇵🇱 Wrocław, Poland