Mindful Network Dynamics Regulation Under Stress

NCT05541263 | Terminated

• 1 other identifier: NL74345.091.20
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress

Keywords

Mindfulness; Stress; Neuroimaging

Outcome Measures

Primary Outcomes (1)

• Difference in perceived stress between experimental and control group

  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

Secondary Outcomes (17)

• Depressive symptoms

  At baseline, 3 months, 6 months

• Anxiety

  At baseline, 3 months, 6 months

• Alcohol use

  At baseline, 3 months, 6 months

• Childhood trauma

  At baseline

• Personality traits

  At baseline, 3 months, 6 months

Other Outcomes (1)

• Daily life stress reactivity

  At baseline, 3 months

Study Arms (2)

MBSR group

EXPERIMENTAL

The MBSR group participants will receive an Mindfulness Based Stress Reduction training programme over 2 months.

Behavioral: Mindfulness Based Stress Reduction

Wait-list group

NO INTERVENTION

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.

Interventions

Mindfulness Based Stress Reduction BEHAVIORAL

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)

Also known as: MBSR

MBSR group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to give informed consent.
• Perceived Stress Scale score ≥ 16.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Medical Center

Nijmegen, Gelderland, 6500HB, Netherlands

Location

Related Publications (6)

• Alsubaie M, Abbott R, Dunn B, Dickens C, Keil TF, Henley W, Kuyken W. Mechanisms of action in mindfulness-based cognitive therapy (MBCT) and mindfulness-based stress reduction (MBSR) in people with physical and/or psychological conditions: A systematic review. Clin Psychol Rev. 2017 Jul;55:74-91. doi: 10.1016/j.cpr.2017.04.008. Epub 2017 Apr 23.

  PMID: 28501707 BACKGROUND

• Hermans EJ, Henckens MJ, Joels M, Fernandez G. Dynamic adaptation of large-scale brain networks in response to acute stressors. Trends Neurosci. 2014 Jun;37(6):304-14. doi: 10.1016/j.tins.2014.03.006. Epub 2014 Apr 21.

  PMID: 24766931 BACKGROUND

• Lyndon MP, Strom JM, Alyami HM, Yu TC, Wilson NC, Singh PP, Lemanu DP, Yielder J, Hill AG. The relationship between academic assessment and psychological distress among medical students: a systematic review. Perspect Med Educ. 2014 Dec;3(6):405-418. doi: 10.1007/s40037-014-0148-6.

  PMID: 25428333 BACKGROUND

• Khoury B, Sharma M, Rush SE, Fournier C. Mindfulness-based stress reduction for healthy individuals: A meta-analysis. J Psychosom Res. 2015 Jun;78(6):519-28. doi: 10.1016/j.jpsychores.2015.03.009. Epub 2015 Mar 20.

  PMID: 25818837 BACKGROUND

• Kabat-Zinn J, Massion AO, Kristeller J, Peterson LG, Fletcher KE, Pbert L, Lenderking WR, Santorelli SF. Effectiveness of a meditation-based stress reduction program in the treatment of anxiety disorders. Am J Psychiatry. 1992 Jul;149(7):936-43. doi: 10.1176/ajp.149.7.936.

  PMID: 1609875 BACKGROUND

• Kogias N, Geurts DEM, Krause F, Speckens AEM, Hermans EJ. Study protocol for a randomised controlled trial investigating the effects of Mindfulness Based Stress Reduction on stress regulation and associated neurocognitive mechanisms in stressed university students: the MindRest study. BMC Psychol. 2023 Jul 1;11(1):194. doi: 10.1186/s40359-023-01220-4.

  PMID: 37393359 DERIVED

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Prof. Dr. Erno Hermans

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Baseline Measurements will occur before group assignments and therefore both participants and researchers are blinded to these measurements. Post-treatment measurements are de-blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will perform a randomized, wait-list controlled trial with a Mindfulness-Based Stress Reduction (MBSR) intervention, based on the programme developed by Kabat-Zinn (1982).

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 15, 2022
• Study Start: March 1, 2021
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2025
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: 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.

Locations

NL (1)