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Mindful Network Dynamics Regulation Under Stress (MindRest)

19. September 2022 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

120

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

    • Gelderland
      • Nijmegen, Gelderland, Niederlande, 6500HB
        • Rekrutierung
        • Radboud University Medical Center
        • Kontakt:
        • Kontakt:
        • Hauptermittler:
          • Prof. Dr. Erno Hermans
        • Unterermittler:
          • Prof. Dr. Anne Speckens
        • Unterermittler:
          • Dr. Florian Krause
        • Unterermittler:
          • Dr. Dirk Geurts
        • Unterermittler:
          • Nikos Kogias

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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)
Andere Namen:
  • MBSR
Kein Eingriff: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Difference in perceived stress between experimental and control group
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Depressive symptoms
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Daily life stress reactivity
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. März 2021

Primärer Abschluss (Voraussichtlich)

31. Januar 2024

Studienabschluss (Voraussichtlich)

31. Juli 2024

Studienanmeldedaten

Zuerst eingereicht

12. September 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. September 2022

Zuerst gepostet (Tatsächlich)

15. September 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. September 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. September 2022

Zuletzt verifiziert

1. Juni 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • NL74345.091.20

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Ja

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

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.

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • Studienprotokoll
  • Statistischer Analyseplan (SAP)
  • Klinischer Studienbericht (CSR)
  • Analytischer Code

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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