Clinical trial NCT06241534: Supporting Methods in Cardiovascular Diseases Rehabilitation
Official title: Evaluation of the Effectiveness of Modern Technologies in Psychologically-enhanced Rehabilitation in Patients With Cardiovascular Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Coronary Artery Disease
Mood Disorders
Depressive Symptoms
Anxiety
Stress
Keywords: cardiac rehabilitation
psychotherapy
therapeutic recordings
virtual reality
depression
anxiety
stress
Lead sponsor: Wroclaw University of Health and Sport Sciences
Sponsor class: OTHER
Collaborators: name: Gajda-Med District Hospital
name: Cardiology Center Pro Corde
name: Healthcare Innovation Technology Lab, IRCCS San Camillo Hospital
First posted: 2024-02-05
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale Hospital Anxiety and Depression Scale
timeFrame: 15 minutes
measure: Perception of Stress Questionnaire
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Wrocław
country: Poland
facility: Cardiology Center Pro Corde
Study officials:
affiliation: Wroclaw University of Health and Sport Sciences
name: Joanna Szczepańska-Gieracha, Prof.
role: STUDY_DIRECTOR
affiliation: Wroclaw University of Health and Sport Sciences
name: Adam Wrzeciono, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiology Center Pro Corde
name: Sandra Jóźwik, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Healthcare Innovation Technology Lab, IRCCS San Camillo Hospital
name: Błażej Cieślik, Ph.D.
role: STUDY_CHAIR
affiliation: Healthcare Innovation Technology Lab, IRCCS San Camillo Hospital
name: Paweł Kiper, Ph.D.
role: STUDY_CHAIR
affiliation: Gajda-Med District Hospital
name: Robert Gajda, Prof.
role: STUDY_DIRECTOR
References:
citation: Natt Och Dag Y, Mehlig K, Rosengren A, Lissner L, Rosvall M. Negative emotional states and negative life events: Consequences for cardiovascular health in a general population. J Psychosom Res. 2020 Feb;129:109888. doi: 10.1016/j.jpsychores.2019.109888. Epub 2019 Nov 29.
citation: Silverman AL, Herzog AA, Silverman DI. Hearts and Minds: Stress, Anxiety, and Depression: Unsung Risk Factors for Cardiovascular Disease. Cardiol Rev. 2019 Jul/Aug;27(4):202-207. doi: 10.1097/CRD.0000000000000228.
citation: Szczepanska-Gieracha J, Morka J, Kowalska J, Kustrzycki W, Rymaszewska J. The role of depressive and anxiety symptoms in the evaluation of cardiac rehabilitation efficacy after coronary artery bypass grafting surgery. Eur J Cardiothorac Surg. 2012 Nov;42(5):e108-14. doi: 10.1093/ejcts/ezs463. Epub 2012 Aug 19.
citation: Szczepanska-Gieracha J, Jozwik S, Cieslik B, Mazurek J, Gajda R. Immersive Virtual Reality Therapy as a Support for Cardiac Rehabilitation: A Pilot Randomized-Controlled Trial. Cyberpsychol Behav Soc Netw. 2021 Aug;24(8):543-549. doi: 10.1089/cyber.2020.0297. Epub 2021 Feb 11.
citation: Jozwik S, Cieslik B, Gajda R, Szczepanska-Gieracha J. Evaluation of the Impact of Virtual Reality-Enhanced Cardiac Rehabilitation on Depressive and Anxiety Symptoms in Patients with Coronary Artery Disease: A Randomised Controlled Trial. J Clin Med. 2021 May 16;10(10):2148. doi: 10.3390/jcm10102148.
citation: Jozwik S, Cieslik B, Gajda R, Szczepanska-Gieracha J. The Use of Virtual Therapy in Cardiac Rehabilitation of Female Patients with Heart Disease. Medicina (Kaunas). 2021 Jul 28;57(8):768. doi: 10.3390/medicina57080768.
citation: Jozwik S, Wrzeciono A, Cieslik B, Kiper P, Szczepanska-Gieracha J, Gajda R. The Use of Virtual Therapy in Cardiac Rehabilitation of Male Patients with Coronary Heart Disease: A Randomized Pilot Study. Healthcare (Basel). 2022 Apr 16;10(4):745. doi: 10.3390/healthcare10040745.