Clinical trial NCT05541263: Mindful Network Dynamics Regulation Under Stress
Official title: 'MindRest: Mindful Network Dynamics Regulation Under Stress
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stress
Keywords: Mindfulness
Stress
Neuroimaging
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: PREVENTION

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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Difference in perceived stress between experimental and control group
timeFrame: Change between baseline and 3 months
Secondary outcomes:
measure: Depressive symptoms
timeFrame: At baseline, 3 months, 6 months
measure: Anxiety
timeFrame: At baseline, 3 months, 6 months
measure: Alcohol use
timeFrame: At baseline, 3 months, 6 months
measure: Childhood trauma
timeFrame: At baseline
measure: Personality traits
timeFrame: At baseline, 3 months, 6 months
measure: Repetitive negative thinking
timeFrame: At baseline, 3 months, 6 months
measure: Cognitive reactivity
timeFrame: At baseline, 3 months, 6 months
measure: Allowing of emotions
timeFrame: At baseline, 3 months, 6 months
measure: Mindfulness skills
timeFrame: Time Frame: At baseline, 3 months, 6 months
measure: Self-compassion
timeFrame: At baseline, 3 months, 6 months
measure: Stress Resilience
timeFrame: At baseline, 3 months, 6 months
measure: Positive mental health
timeFrame: At baseline, 3 months, 6 months
measure: Blood Oxygen Level Dependent (BOLD) signal
timeFrame: At baseline, 3 months
measure: Automatic exogenous stress regulation
timeFrame: At baseline, 3 months
measure: Controlled exogenous stress regulation
timeFrame: At baseline, 3 months
measure: Automatic endogenous stress regulation
timeFrame: At baseline, 3 months
measure: Controlled endogenous stress regulation
timeFrame: At baseline, 3 months
Other outcomes:
measure: Daily life stress reactivity
timeFrame: At baseline, 3 months
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Prof. Dr. Erno Hermans
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.