Improving cardiac rehabilitation by addressing sleep and stress
OPTImizing CArdiac REhabilitation by REfining Sleep and STress
This study is testing whether adding a program that helps improve sleep and reduce stress to regular heart rehab can help people with heart problems feel better overall.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 3 sites (Eindhoven, North Brabant and 2 other locations) |
| Trial ID | NCT06505109 on ClinicalTrials.gov |
What this trial studies
This project investigates the effectiveness and costs of integrating a behavioral program focused on sleep and stress into cardiac rehabilitation (CR) for patients with cardiovascular diseases. The study involves a multicenter randomized controlled trial where one group of patients will receive standard CR along with the RESST intervention, which includes group sessions based on Acceptance and Commitment Therapy and Cognitive Behavioral Therapy. The primary outcomes include improvements in sleep quality and perceived stress, while secondary outcomes will assess quality of life, chronic stress biomarkers, and physical fitness. The study also aims to explore the relationship between sleep, stress, and other health outcomes, considering diversity factors such as sex and socioeconomic status.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are proficient in Dutch and experiencing sleep and/or stress problems.
Not a fit: Patients with severe psychiatric, cognitive, or physical comorbidities that impede participation in cardiac rehabilitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the quality of life and health outcomes for patients undergoing cardiac rehabilitation.
How similar studies have performed: Other studies have shown promise in integrating behavioral interventions into cardiac rehabilitation, but this specific approach focusing on sleep and stress is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participate in CR at one of the study centres for any cardiac diagnosis or reason as stated in the Dutch guidelines * Age at or above 18 years * Proficient in the Dutch language * Experiencing sleep and/or stress problems as indicated by a high score on the Pittsburgh Sleep Quality Index (PSQI score \>5) or Perceived Stress Scale-10 (PSS-10 score \>13) * Signed informed consent Exclusion Criteria: * 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.
Where this trial is running
Eindhoven, North Brabant and 2 other locations
- Máxima Medisch Centrum — Eindhoven, North Brabant, Netherlands (Recruiting)
- Capri Hartrevalidatie — Rotterdam, South Holland, Netherlands (Recruiting)
- Capri Hartrevalidatie — The Hague, South Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Nienke ter Hoeve, PhD
- Email: n.terhoeve@erasmusmc.nl
- Phone: +31107033190
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.