OPTImizing CArdiac REhabilitation by REfining Sleep and STress
NCT ID: NCT06505109
Last Updated: 2025-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2024-08-28
2027-01-31
Brief Summary
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Detailed Description
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The project involves a multicenter randomized controlled trial. The intervention group (100 patients) will receive standard CR along with the RESST intervention, consisting of 5-6 on-site group sessions integrating principles from Acceptance and Commitment Therapy and Cognitive Behavioral Therapy and focused on improving sleep and stress. The control group (100 patients) will receive standard multidisciplinary CR only.
The primary outcomes of the study include both objective and subjective measures of sleep, as well as perceived stress. Secondary outcomes encompass quality of life, chronic stress biomarkers, cardiometabolic risk factors, physical fitness, lifestyle components and psychosocial wellbeing. These outcomes will be assessed before and after the intervention, as well as at a 6-month follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention group
The intervention group will receive standard CR along with the RESST intervention, consisting of 5-6 on-site group sessions, focused on sleep and stress, integrating principles from Acceptance and Commitment Therapy and Cognitive Behavioral Therapy.
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 till 6 meetings of 90 till 120 minutes in the local rehabilitation centre during a time period of 3 till 4 months.
Control group
The control group will receive standard CR only. Standard CR programs last around 3-4 months and include two supervised exercise sessions per week. In addition, educational sessions are provided, covering topics such as medical information, cardiovascular risk factors, adopting a heart-healthy lifestyle, and coping with emotions. Depending on the patient's specific needs, counselling sessions on stress management, smoking cessation, and healthy diet are available, and individual counselling can be provided by a social worker, dietician, or psychologist/psychiatrist.
No interventions assigned to this group
Interventions
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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 till 6 meetings of 90 till 120 minutes in the local rehabilitation centre during a time period of 3 till 4 months.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Capri Hartrevalidatie
UNKNOWN
Maxima Medical Center
OTHER
ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Erasmus Medical Center
OTHER
Responsible Party
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N. (Nienke) ter Hoeve PhD
Principal Investigator
Locations
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Máxima Medisch Centrum
Eindhoven, North Brabant, Netherlands
Capri Hartrevalidatie
Rotterdam, South Holland, Netherlands
Capri Hartrevalidatie
The Hague, South Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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10930012310027
Identifier Type: OTHER
Identifier Source: secondary_id
NL86677.078.24
Identifier Type: -
Identifier Source: org_study_id
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