OPTImizing CArdiac REhabilitation by REfining Sleep and STress
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasmus Medical Center
About this trial
The primary objective of this project is to investigate the effectiveness and costs of integrating a behavioural program targeting sleep and stress (the RESST intervention) into cardiac rehabilitation (CR). In addition, the investigators will also study whether parameters regarding diversity (e.g., sex, ethnicity, socioeconomic position) are associated with intervention effectiveness. Furthermore, the investigators aim to explore the (bidirectional) relation between sleep and stress on the one hand, and other lifestyle components and health outcomes on the other hand.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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.
Trial design
Treatments tested in this trial
- RESST
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Erasmus Medical Center
Lead sponsor
Capri Hartrevalidatie
Collaborator
Maxima Medical Center
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Source ClinicalTrials.gov