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Mindful Network Dynamics Regulation Under Stress (MindRest)

19 września 2022 zaktualizowane przez: Radboud University Medical Center

'MindRest: Mindful Network Dynamics Regulation Under Stress

This study aims to assess the effectiveness of Mindfulness Based Stress reduction to reduce perceived stress in a highly stressed student population, while concurrently investigating neural mechanisms of the intervention. The investigators will perform a randomized, wait-list controlled trial assessing clinical and neurocognitive outcomes as well as measures of daily life stress reactivity.

Przegląd badań

Status

Rekrutacyjny

Warunki

Szczegółowy opis

Rationale: 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. 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 improve the provided interventions . In the light of preliminary psychological study results on MBSR the investigators hypothesize that 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, the investigators 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.

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: The investigators will perform a two-arm randomized, wait-list controlled trial with a randomisation ratio of 1:1. 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 experimental 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 3 months after baseline. 6 months after baseline there will be a follow-up CA. Participants in the wait-list group will then receive an MBSR training, after which they will perform another CA.

Study population: The investigators will recruit 60 students per group ( total: 120) from Radboud University, Radboudumc, and HAN University of Applied Sciences in Arnhem and Nijmegen with high perceived stress. Participants above 18 years, able to give consent, who score ≥ 16 on the Perceived Stress Scale will be prompted to join our study. Participants will be excluded if they are receiving current specialised psychological or psychiatric treatment or medication, if they have insufficient comprehension of the Dutch language, if they have physical, cognitive, or intellectual impairments interfering with participation, such as deafness, blindness, or sensori-motor handicaps, if they were formerly or currently involved in MBCT or MBSR training, if they have a current drug or alcohol addiction, and if they have contraindications for MRI scanning (e.g., pacemaker, implanted metal parts, deep brain stimulation, claustrophobia, epilepsy, brain surgery, pregnancy).

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 (7 months after baseline), therefore acting as a wait-list control group during the measurements.

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

120

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

    • Gelderland
      • Nijmegen, Gelderland, Holandia, 6500HB
        • Rekrutacyjny
        • Radboud University Medical Center
        • Kontakt:
        • Kontakt:
        • Główny śledczy:
          • Prof. Dr. Erno Hermans
        • Pod-śledczy:
          • Prof. Dr. Anne Speckens
        • Pod-śledczy:
          • Dr. Florian Krause
        • Pod-śledczy:
          • Dr. Dirk Geurts
        • Pod-śledczy:
          • Nikos Kogias

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • Able to give informed consent.
  • 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).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: MBSR group
The MBSR group participants will receive an Mindfulness Based Stress Reduction training programme over 2 months.
The intervention used is an MBSR training which is based on the Mindfulness-Based Stress Reduction programme as developed by Kabat-Zinn (1982). The training consists of 8 weekly sessions lasting 2,5 hours. A silent day of approximately 6 hours is also included, as well as daily home practice assignments of about 45 minutes. During the training participants will learn to focus their attention in the present moment in an accepting and non-judgemental way, rather than ruminating about past and future experiences. The training includes formal exercises during which participants will practice the body scan, sitting meditation, walking meditation and mindful movement. Informal exercises are also included, such as performing a daily activity with full attention to the present experience. The training is led by qualified teachers meeting the advanced criteria of the Association of Mindfulness Based Teachers in the Netherlands and Flanders (www.vmbn.nl)
Inne nazwy:
  • MBSR
Brak interwencji: Wait-list group
The wait-list control group participants will wait while the experimental group is participating in the Mindfulness Based Stress Reduction training. This group will follow the training at the end of the study (7 months after baseline), after all relevant measurements are concluded.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Difference in perceived stress between experimental and control group
Ramy czasowe: Change between baseline and 3 months
This is measured by the total score of the Perceived Stress Scale (PSS) 10-item questionnaire (range 0-40), which evaluates the degree to which an individual perceives their life as unpredictable, uncontrollable and overloading.
Change between baseline and 3 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Depressive symptoms
Ramy czasowe: At baseline, 3 months, 6 months
Assessed with the IDS-SR: Inventory of Depressive Symptomatology Self-Report, which is a self-reported 30-item measure of depressive symptom severity (range 0-93).
At baseline, 3 months, 6 months
Anxiety
Ramy czasowe: At baseline, 3 months, 6 months
Assessed with the STAI: State and Trait Anxiety Inventory, which is a self-reported 20-item measure of trait (range 20-80) and a self-reported 20-item measure (range 20-80) state anxiety.
At baseline, 3 months, 6 months
Alcohol use
Ramy czasowe: At baseline, 3 months, 6 months
Assessed with the AUDIT: Alcohol Use Disorders Identification Test, which is a 10-item screening tool developed by the World Health Organization (WHO) to assess alcohol consumption, drinking behaviours, and alcohol-related problems (range 0-40).
At baseline, 3 months, 6 months
Childhood trauma
Ramy czasowe: At baseline
Assessed with the MACE-X: Maltreatment and Abuse Chronology of Exposure Scale, which is a self-reported questionnaire which used to assess the extent as well as the severity of traumatic experiences of participants in their childhood.
At baseline
Personality traits
Ramy czasowe: At baseline, 3 months, 6 months
Assessed with the NEO-FFI: NEO Five Factor Inventory, which is a 60-item self-reported questionnaire and covers a set of five broad personality trait dimensions or domains: Extraversion, Agreeableness, Conscientiousness, Neuroticism, and Openness to Experience.
At baseline, 3 months, 6 months
Repetitive negative thinking
Ramy czasowe: At baseline, 3 months, 6 months
Assessed with the PTQ: Perseverative Thinking Questionnaire, which is a 15-item self-reported questionnaire and is used to assess repetitive negative thinking in a content-free manner (range 0-60).
At baseline, 3 months, 6 months
Cognitive reactivity
Ramy czasowe: At baseline, 3 months, 6 months
Assessed with the LEIDS-R: Leiden Index of Depression Sensitivity - Revised, which is a 34-item self-reported questionnaire measuring cognitive reactivity to sadness (range 0-136).
At baseline, 3 months, 6 months
Allowing of emotions
Ramy czasowe: At baseline, 3 months, 6 months
Assessed with the AAQ: Acceptance and Action Questionnaire, which is a 10-item self-reported questionnaire measuring psychological flexibility and experiential acceptance (range 10-70).
At baseline, 3 months, 6 months
Mindfulness skills
Ramy czasowe: Time Frame: At baseline, 3 months, 6 months
Assessed with the FFMQ-SF: short version of the Five-Facet Mindfulness Questionnaire, which is a 24-item self-reported questionnaire measuring five aspects of mindfulness, namely observation, description, aware actions, non-judgemental inner experience, and non-reactivity.
Time Frame: At baseline, 3 months, 6 months
Self-compassion
Ramy czasowe: At baseline, 3 months, 6 months
Assessed with the SCS-S: short version of the Self-Compassion Scale, which is a 12-item self-reported questionnaire measuring consisting of six components, including self-kindness, self-judgment, common humanity, isolation, mindfulness and over-identification.
At baseline, 3 months, 6 months
Stress Resilience
Ramy czasowe: At baseline, 3 months, 6 months
Assessed with the CD-RISC: Connor-Davidson Resilience Scale, which is a 25-item self-reported measure of stress resilience (range 0-100)
At baseline, 3 months, 6 months
Positive mental health
Ramy czasowe: At baseline, 3 months, 6 months
Assessed with the MHC-SF: short form of the Mental Health Continuum, which is a 14-item self-report questionnaire that assesses emotional, psychological and social well-being (range 0-70).
At baseline, 3 months, 6 months
Blood Oxygen Level Dependent (BOLD) signal
Ramy czasowe: At baseline, 3 months
Assessed using Functional Magnetic Resonance Imaging (fMRI) during four tasks (Resting State, Fear conditioning paradigm, Emotional Stroop task, and Self-regulation using neurofeedback). This will be used to determine activity, connectivity and cohesion patterns of largescale brain networks during these stress regulation tasks.
At baseline, 3 months
Automatic exogenous stress regulation
Ramy czasowe: At baseline, 3 months
Assessed using a differential fear conditioning and extinction paradigm. This task will be used to measure the retention of safety learning in an experimental model of exposure therapy. This measure is operationalized as the reduction of spontaneous recovery of autonomic nervous system reactivity (skin conductance, heart rate, and pupil dilation responses) to fear-conditioned stimuli one day after extinction of fearful memories (i.e., safety learning).
At baseline, 3 months
Controlled exogenous stress regulation
Ramy czasowe: At baseline, 3 months
Assessed during a Stroop-like emotional conflict resolution task. We will measure cognitive control processes in the context of conflicting emotional information by measuring reaction times and accuracy scores during the task.
At baseline, 3 months
Automatic endogenous stress regulation
Ramy czasowe: At baseline, 3 months
Assessed using during a resting state Functional Magnetic Resonance Imaging (fMRI) scan following a laboratory stress-induction procedure. Stress responses will be assessed through repeated measurement of salivary cortisol levels, pupillary responses and heart rate.
At baseline, 3 months
Controlled endogenous stress regulation
Ramy czasowe: At baseline, 3 months
Assessed using a Real-time Functional Magnetic Resonance Imaging (fMRI) Neurofeedback task based on largescale brain network balance. This task will test individuals' ability to dynamically self-regulate their configuration of largescale brain networks.
At baseline, 3 months

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Daily life stress reactivity
Ramy czasowe: At baseline, 3 months
Assessed using 6 surveys per day with mood- and stress-related questions (i.e. ecological momentary assessments) for 6 continuous days, coupled with physiological measures (heart rate, skin conductance, skin temperature, and movement), to assess stress reactivity in daily life.
At baseline, 3 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Główny śledczy: Prof. Dr. Erno Hermans, Radboud University Medical Center

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 marca 2021

Zakończenie podstawowe (Oczekiwany)

31 stycznia 2024

Ukończenie studiów (Oczekiwany)

31 lipca 2024

Daty rejestracji na studia

Pierwszy przesłany

12 września 2022

Pierwszy przesłany, który spełnia kryteria kontroli jakości

12 września 2022

Pierwszy wysłany (Rzeczywisty)

15 września 2022

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 września 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

19 września 2022

Ostatnia weryfikacja

1 czerwca 2022

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • NL74345.091.20

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAk

Opis planu IPD

Data can be shared upon request using the Donders Institute research data repository (http://data.donders.ru.nl) in accordance to institutional and EU guidelines.

Ramy czasowe udostępniania IPD

The data will be stored and archived through the data management infrastructure of the Donders Institute, and will be kept for at least 15 years.

Kryteria dostępu do udostępniania IPD

Access to data is managed by the researchers responsible for the data and they can decide to give access rights to other individuals when necessary or requested.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • Protokół badania
  • Plan analizy statystycznej (SAP)
  • Raport z badania klinicznego (CSR)
  • Kod analityczny

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Mindfulness Based Stress Reduction

3
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