The main objective of this study is to assess the effectiveness of MBSR to reduce perceived stress in a highly stressed student population. Our main objective regarding working mechanisms of MBSR is to assess possible MBSR induced changes in large-…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Psychological Distress
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is perceived stress, which is measured by the
Perceived Stress Scale (PSS) post-treatment.
Secondary outcome
We will also assess secondary outcome measures, including both self-reported
questionnaires measuring depressive symptoms (Q-IDS-SR), anxiety (State and
Trait Anxiety Inventory), alcohol use (AUDIT), childhood trauma (MACE-X),
personality traits (NEO-FFI), repetitive negative thinking (PTQ), cognitive
reactivity (LEIDS-R), allowing of emotions (Acceptance and Action
Questionnaire), mindfulness skills (short version of the Five-Facet Mindfulness
Questionnaire), self-compassion (short version of the Self-Compassion Scale),
stress Resilience (CD-RISC), and positive mental health (Mental Health
Continuum). Moreover, we will perform neurocognitive tasks that are selected
specifically to assess exogenously as well as endogenously driven
stress-regulation with and without task demands, including a fear conditioning
and extinction paradigm, an emotional conflict resolution task, a resting state
task under stress, and a real-time fMRI neurofeedback task. During these tasks
we will record task performance, neuroimaging data (i.e. fMRI data), as well as
physiological data (heart rate, respiration, skin conductance, pupil size, and
salivary cortisol). In addition, we will administer ecological momentary
assessments, coupled with physiological measures (heart rate, skin conductance,
skin temperature, and movement), to assess stress reactivity in daily life.
Background summary
Prolonged stress exposure can put people at risk of developing stress-related
symptomatology, such as burnout, sleeping disorders, depression and anxiety.
Students reporting high levels of perceived stress are an at-risk population
that could potentially benefit from a stress-reduction intervention (LeBlanc,
2014; Lyndon et al., 2014). One approach to reduce stress is Mindfulness Based
Stress Reduction (MBSR). Although proven effective, additional evidence is
required on the effectiveness of MBSR in reducing stress-related symptoms in
student sample pre-selected on high stress. Furthermore, the working mechanisms
of MBSR are only marginally understood. This is problematic, because gaining
better mechanistic insight on how MBSR works might lead (1) to basic scientific
insights into stress and stress resilience and (2) clinically, to the
opportunity to better allocate treatment for the individual. In the light of
preliminary psychological study results on MBSR we hypothesize that (in
contrast to other stress-management strategies) MBSR will not only foster
stress-reduction via cognitive control but also via experiential exposure. In
accordance with this hypothesis and based on neurocognitive findings in basic
stress research and previous mechanistic studies on MBSR, we will assess
whether MBSR indeed leads to improved stress-regulation by enhancing both
cognitive and affective processing, which will be reflected in neural network
configuration.
Study objective
The main objective of this study is to assess the effectiveness of MBSR to
reduce perceived stress in a highly stressed student population. Our main
objective regarding working mechanisms of MBSR is to assess possible MBSR
induced changes in large-scale neural network configuration and self-regulation
of these networks. Additionally, this study aims to explore possible mediators
and moderators of the treatment effect, both in terms of psychological traits,
and neural patterns.
Study design
We will perform a randomized, wait-list controlled trial. Participants will be
randomised into a treatment and wait-list group after baseline Clinical
Assessments (CA), Neurocognitive Assessments (NA), and Ecological Momentary
Assessments (EMA). In the following two months the treatment group will
participate in an MBSR training and the control group will wait for two months.
Another CA and NA and EMA will take place post- treatment. Three months later
there will be a follow-up CA.
Intervention
Participants in the treatment group will follow an MBSR training which consists
of 8 weekly sessions lasting 2,5 hours; a silent day of approximately 6 hours;
and daily home practice assignments of about 45 minutes. The control group will
follow the training at the end of the study, therefore acting as a wait-list
control group during the measurements.
Study burden and risks
Participants will have to attend a short screening meeting, 2 visits at the MRI
lab and 2 visits at behavioural labs for neurocognitive measurements, and will
also have to answer multiple questionnaires as part of the CA and EMA. The
risks of participation in the MBSR treatment as well as the MRI measurements
are negligible.
Kapittelweg 29
Nijmegen 6525EN
NL
Kapittelweg 29
Nijmegen 6525EN
NL
Listed location countries
Age
Inclusion criteria
Age above 18 years.
Able to give informed consent.
Score in Perceived Stress Scale score >= 16
Exclusion criteria
Current specialised psychological or psychiatric treatment or medication.
Insufficient comprehension of the Dutch language.
Physical, cognitive, or intellectual impairments interfering with
participation, such as deafness, blindness, or sensori-motor handicaps.
Formerly/currently involved in MBCT or MBSR training.
Current drug or alcohol addiction.
Contraindications for MRI scanning (e.g., pacemaker, implanted metal parts,
deep brain stimulation, claustrophobia, epilepsy, brain surgery, pregnancy).
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 |
|---|---|
| CCMO | NL74345.091.20 |