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OPTICARE-RESSTBehavioral Intervention for Sleep and Stress in Cardiac Rehabilitation

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Study Aim

This study aims to evaluate whether a behavioral intervention can improve sleep and reduce stress in individuals undergoing cardiac rehabilitation.

What is being tested

RESST

Behavioral
Who is being recruted

Cardiovascular Diseases

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2024
See protocol details

Summary

Principal SponsorErasmus Medical Center
Study ContactNienke ter Hoeve, PhD
Last updated: March 14, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleOPTImizing CArdiac REhabilitation by REfining Sleep and STress
NCT06505109
Principal SponsorErasmus Medical Center
Study ContactNienke ter Hoeve, PhD
Last updated: March 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Cardiovascular Diseases

Criteria

5 inclusion criteria required to participate
Age at or above 18 years

Proficient in the Dutch language

Signed informed consent

Participate in CR at one of the study centres for any cardiac diagnosis or reason as stated in the Dutch guidelines

Show More Criteria

2 exclusion criteria prevent from participating
Severe psychiatric, cognitive or physical comorbidity that would impede CR participation

Active treatment for sleep disorders, stress, or other forms of (behavioural) therapy at the start of the study or expected to start within the first 6 months of the study, that could interfere with the RESST intervention. Note: Participants with previously diagnosed sleep disorders are eligible if they still experience sleep or stress problems, unless they fall under the above criteria. Participants who received a prior treatment that is still ongoing but has resulted in a stable sleep and stress condition in the 3 months before the cardiovascular event (e.g., Continuous Positive Airway Pressure (CPAP)) are eligible

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The intervention group will receive standard CR along with the RESST intervention, consisting of 5 on-site group sessions, focused on sleep and stress, integrating principles from Acceptance and Commitment Therapy and Cognitive Behavioral Therapy.

Study 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

Recruiting

Máxima Medisch Centrum

Eindhoven, NetherlandsOpen Máxima Medisch Centrum in Google Maps
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Capri Hartrevalidatie

Rotterdam, Netherlands
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Capri Hartrevalidatie

The Hague, Netherlands
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3 Study Centers