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 CR. In addition to overall effectiveness, we will also study whether…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcomes of the study include both objective and subjective
measures of sleep, as well as perceived stress. These outcomes will be assessed
before and after the intervention, as well as at a 6-month follow-up.
Secondary outcome
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.
Background summary
Cardiac rehabilitation (CR) focuses on the secondary prevention of
cardiovascular disease (CVD) by promoting a healthy lifestyle and is a valuable
approach to improve quality of life, mortality and hospital readmissions.
However, optimization of CR is necessary. Current CR programs pay insufficient
attention to sleep and stress problems, despite more than 50% of CVD patients
experiencing sleep problems and high stress levels. Both sleep and stress are
associated with adverse cardiovascular health and a decreased quality of life.
We hypothesize that 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
Study objective
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 CR. In addition to overall effectiveness, we will also
study whether parameters regarding diversity (e.g., sex, ethnicity,
socioeconomic position) are associated with intervention effectiveness.
Furthermore, we 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
The project involves a multicenter randomized controlled trial.
Intervention
The intervention group 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.
Controls will receive standard CR only.
Study burden and risks
All participating patients will receive CR as recommended by the guidelines.
Subjects randomized to the RESST intervention will receive on top of that 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. Regardless
of randomization, all participants are invited to visit the rehabilitation
centre three times during the study period (at start, 3-4 months and 6 months)
for a 45 min physical examination (weight, length, blood pressure, smoking
behaviour), for the collection of a small hair sample and for collecting
information on prior sleep and stressproblems and currect medication use. At
these time points patients also receive a set of questionnaires to fill out at
home (30-45 min). Furthermore, at these time point, subjects will receive a
GENEACTIV wristwatch (an activity monitor measuring physical behaviour and
sleep) to wear around their wrist for a period of 7 days and nights and are
asked to keep an electronic diary during the same week. The burden of these
measurements is expected to be minimal. Nevertheless, questionnaires may be
personal and/or confrontational for patients. Additionally, the experience of
hair sample collection might be impactful for some patients. Therefore,
patients have the option to refuse the collection of this hair sample and are
still be able to participate in the study. Burden of wearing small activity
monitors and filling out electronics diaries is expected to be low, based on
experience in previous studies (e.g. MEC-2016-655, MEC-2016-622). To lower the
burden for participants, visits for measurements will be combined with other
visits to the rehabilitation centre whenever possible. Furthermore, travel
costs for the visit of these measurements will be reimbursed. Patients will
have no direct benefit from participating in this study, although patients
randomized to the intervention group might benefit of the novel intervention by
improving sleep and stress levels which in turn is expected to result in an
improved physical and mental health. With regard to risks, it has been reported
that cognitive behavioural therapy for sleep problem due to insomnia can lead
to negative side effects such as a difficulty remembering things, headache,
fatigue, difficulty with concentration, reduced energy, and irritability.
Nevertheless, these side effects are short lived and have been attributed
mainly to strict sleep restriction components that are not imposed in our
intervention.
Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
1) Participating in cardiac rehabilitation 2) age above 18 years, 3) proficient
in the Dutch language, 4) 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)
Exclusion criteria
1) severe psychiatric, cognitive or physical comorbidity that would impede
cardiac rehabilitation participation.
2) 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06505109 |
| CCMO | NL86677.078.24 |