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.
Study Design
Randomized controlled trial
Study Setting(s)
Study Acronym
Study Hypotheses
Adding a behavioural intervention will improve sleep and perceived stress (primary outcomes), along with positive outcomes on biomarkers of chronic stress, QoL, cardiometabolic risk factors, physical fitness, lifestyle components, and psychosocial well-being.
Condition
(Cardio)vascular disease
Intervention
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 till 6 meetings of 90 till 120 minutes in the local rehabilitation centre during a time period of 3 till 4 months.
Primary Outcome Measure
Information regarding sleep and stress
Secondary Outcome Measure
Cortisol level
Cortisone level
Weight
Height
Body Mass Index (BMI)
Blood pressure
Smoking behaviour
Smoking behaviour
Muscle strength
Physical activity
Sedentary behaviour
Alcohol use
Health related quality of life
Health related quality of life
Fatigue
Daytime sleepiness
Anxiety and depression
Participation in society
Estimated Cardiorespiratory fitness
Presence of restless leg syndrome
Presence of insomnia
The risk of the presence of obstructive sleep apnoea
Costs incurred by the patients
Productivity costs
Perceived sleep
Diet
Momentary fatigue
Momentary stress
Adherence to the CR treatment and RESST intervention
Treatment Satisfaction
Sex
Age
Cardiac diagnosis
Educational level
Relational status
Cardiac risk factors
Cardiac history
Medication usage
Comorbidity
Socioeconomic status
Origin
Employment
Drug use
Current/previous sleep disorder treatment
Eligibility
Participant Type(s)
(Cardio)vascular disease
Age Group
Adult (18-64), Senior (65+)
Sex
Both
Target Number of Participants
200
Total Final Enrolment
Participant Inclusion Criteria
- 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
Participant 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.
