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NCT Number: NCT06241534

Supporting Methods in Cardiovascular Diseases Rehabilitation

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.

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Key information

Conditions

Cardiovascular Diseases Anxiety Anxiety Disorders Arterial Occlusive Diseases Arteriosclerosis Behavior Behavioral Symptoms Coronary Artery Disease Coronary Disease Depression Depressive Symptoms Heart Diseases Mental Disorders Mood Disorders Myocardial Ischemia Stress Vascular Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiology Center Pro Corde

Wroclaw, Poland

About this study

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:

  • 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.
  • The comparison of the effectiveness of therapeutic recordings with the effectiveness of VR therapy and Schultz Autogenic Training.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiac rehabilitation

Behavioral

Four weeks of cardiac rehabilitation conducted in an outpatient care facility. Three times per week (80 minutes per day) cardiologically monitored aerobic training consisting of: 40 minutes of interval training on a cycloergometer and 40 minutes of general fitness exercises.

Relaxation-therapeutic recordings

Behavioral

8 sessions of relaxation-therapeutic recordings in the non-sleep deep rest concept.

The content of the recording is based on the 'body scanning technique', which constitutes the core of the therapy. This approach aims to quiet the overactive sympathetic part of the autonomic nervous system. During therapy, the patients take a 'journey' through their own body from feet to head. Following the voice of the narrator, the patient focuses on specific body parts, tries to feel this place and then relaxes tense muscles. Relaxation of individual body parts (muscle groups) is combined with breathing exercises. Conscious and mindful breathing deepens the state of relaxation. Additionally, the recording includes therapeutic suggestions related to making a choice between: overload and relief, holding on and letting go, acting and sensing. Furthermore, suggestions focus the patient on inner wisdom that allows them to make the best decisions.

Virtual reality therapy

Device

8 sessions of VR therapy (each of them 20 minutes long). As a virtual reality source, VR TierOne device (Stolgraf®) were used. Thanks to using head mounted display and the phenomenon of total immersion VR therapy provides an intense visual, auditory and kinesthetic stimulation. It can have a calming and mood-improving effect or help the patients recognize their psychological resources and motivate to the rehabilitation process. In the virtual therapeutic garden there are a rich set of symbols and metaphors based on Ericksonian Psychotherapy approach.The most important is the Garden of Revival which symbolizes the patient's health. It used to be full of life and energy, now it is neglected, requires work to be revived. In the therapeutic process day by day, the therapist tells the patient a symbolic story about his/her situation.

Schultz Autogenic Training

Behavioral

8 sessions of Schultz Autogenic Training (each of them 20 minutes long).

Primary outcomes

  1. Hospital Anxiety and Depression Scale Hospital Anxiety and Depression Scale

    Time frame: 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.

  2. Perception of Stress Questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wroclaw University of Health and Sport Sciences

Other

Collaborators

  • Cardiology Center Pro Corde
  • Gajda-Med District Hospital
  • Healthcare Innovation Technology Lab, IRCCS San Camillo Hospital

Registry information

Official study title

Evaluation of the Effectiveness of Modern Technologies in Psychologically-enhanced Rehabilitation in Patients With Cardiovascular Diseases

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 5, 2024
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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