OPTICARE-RESSTBehavioral Intervention for Sleep and Stress in Cardiac Rehabilitation
This study aims to evaluate whether a behavioral intervention can improve sleep and reduce stress in individuals undergoing cardiac rehabilitation.
RESST
Cardiovascular Diseases
Treatment Study
Summary
Study start date: August 28, 2024
Actual date on which the first participant was enrolled.This study is focused on improving the effectiveness of cardiac rehabilitation (CR) programs for individuals with cardiovascular disease (CVD). CR programs are designed to help patients prevent further heart issues by encouraging a healthy lifestyle, which can improve life quality and reduce hospital visits. However, current programs often overlook the importance of managing sleep and stress, which affect more than half of CVD patients and are linked to poor heart health and lower quality of life. This study aims to test whether adding a behavioral treatment focused on sleep and stress can lead to better sleep, reduced stress, and overall improved health outcomes for these patients. Participants in this study will be split into two groups, each consisting of 100 patients. One group will follow the standard CR program, while the other group will receive additional support through the RESST intervention. This involves 5-6 group sessions that incorporate techniques from Acceptance and Commitment Therapy and Cognitive Behavioral Therapy, specifically targeting improvements in sleep and stress management. The study will measure both the quality of sleep and levels of stress reported by participants, along with other health indicators like quality of life, physical health markers, and overall well-being. Assessments will be conducted before and after the intervention and will include a follow-up check six months later to evaluate the long-term benefits.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.200 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Capri Hartrevalidatie
Rotterdam, NetherlandsCapri Hartrevalidatie
The Hague, Netherlands