Improving cardiac rehabilitation by addressing sleep and stress

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.