RESST: Subjects randomized to the RESST intervention will receive on top of standard rehabilitation a behavioural group intervention focussing on improving sleep and stress. This intervention will consist of 5 group sessions of 120 minutes each in the local rehabilitation centre. Sessions should be completed within a maximum of 4 months since the start of CR.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Objectively assessed sleep duration — At baseline, after 3 months, and after 6 months. This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Objectively assessed sleep-onset latency — At baseline, after 3 months, and after 6 months. This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Objectively assessed wake after sleep onset — At baseline, after 3 months, and after 6 months. This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Objectively assessed sleep efficiency — At baseline, after 3 months, and after 6 months. This will be measured with a GENEACTIV accelerometer for 7 days and nights continuously.
Self-reported sleep quality — At baseline, after 3 months, and after 6 months. This will be measured with the Pittsburgh Sleep Quality Index (PSQI) questionnaire. Score between 0-21, higher score indicates worse sleep quality.
Perceived stress level — At baseline, after 3 months, and after 6 months. This will be measured with the Perceived Stress Scale-10 (PSS-10) questionnaire. Score between 0-40, higher score indicates higher perceived stress.
Trial sites (3)
Facility
City
Region
Status
Máxima Medisch Centrum
Eindhoven
North Brabant
Recruiting
Capri Hartrevalidatie
Rotterdam
South Holland
Recruiting
Capri Hartrevalidatie
The Hague
South Holland
Recruiting
More Erasmus Medical Center trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
