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Mindful Network Dynamics Regulation Under Stress (MindRest)

19. september 2022 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Forventet)

120

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

    • Gelderland
      • Nijmegen, Gelderland, Nederland, 6500HB
        • Rekruttering
        • Radboud University Medical Center
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Prof. Dr. Erno Hermans
        • Underetterforsker:
          • Prof. Dr. Anne Speckens
        • Underetterforsker:
          • Dr. Florian Krause
        • Underetterforsker:
          • Dr. Dirk Geurts
        • Underetterforsker:
          • Nikos Kogias

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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)
Andre navn:
  • MBSR
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Difference in perceived stress between experimental and control group
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Depressive symptoms
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Daily life stress reactivity
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mars 2021

Primær fullføring (Forventet)

31. januar 2024

Studiet fullført (Forventet)

31. juli 2024

Datoer for studieregistrering

Først innsendt

12. september 2022

Først innsendt som oppfylte QC-kriteriene

12. september 2022

Først lagt ut (Faktiske)

15. september 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. september 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. september 2022

Sist bekreftet

1. juni 2022

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • NL74345.091.20

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ja

IPD-planbeskrivelse

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.

IPD-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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.

IPD-deling Støtteinformasjonstype

  • Studieprotokoll
  • Statistisk analyseplan (SAP)
  • Klinisk studierapport (CSR)
  • Analytisk kode

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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