Mindful Network Dynamics Regulation Under Stress
NCT05541263, Not applicable, Terminated, Radboud University Medical Center
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Mindful Network Dynamics Regulation Under Stress | ClinicalTrials.gov |
| NCT number | NCT05541263 | ClinicalTrials.gov |
| Status | Terminated | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 75 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Radboud University Medical Center | ClinicalTrials.gov |
| Conditions | Stress | ClinicalTrials.gov |
| Interventions | Mindfulness Based Stress Reduction | ClinicalTrials.gov |
| First posted | 2022-09-15 | ClinicalTrials.gov |
| Last updated | 2025-05-22 | ClinicalTrials.gov |
Registered outcomes 19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Difference in perceived stress between experimental and control group | 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. | ClinicalTrials.gov |
| Secondary | Depressive symptoms | 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). | ClinicalTrials.gov |
| Secondary | Anxiety | 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. | ClinicalTrials.gov |
| Secondary | Alcohol use | 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). | ClinicalTrials.gov |
| Secondary | Childhood trauma | 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. | ClinicalTrials.gov |
| Secondary | Personality traits | 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. | ClinicalTrials.gov |
| Secondary | Repetitive negative thinking | 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). | ClinicalTrials.gov |
| Secondary | Cognitive reactivity | 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). | ClinicalTrials.gov |
| Secondary | Allowing of emotions | 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). | ClinicalTrials.gov |
| Secondary | Mindfulness skills | 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. | ClinicalTrials.gov |
| Secondary | Self-compassion | 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. | ClinicalTrials.gov |
| Secondary | Stress Resilience | 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) | ClinicalTrials.gov |
| Secondary | Positive mental health | 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). | ClinicalTrials.gov |
| Secondary | Blood Oxygen Level Dependent (BOLD) signal | 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. | ClinicalTrials.gov |
| Secondary | Automatic exogenous stress regulation | 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). | ClinicalTrials.gov |
| Secondary | Controlled exogenous stress regulation | 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. | ClinicalTrials.gov |
| Secondary | Automatic endogenous stress regulation | 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. | ClinicalTrials.gov |
| Secondary | Controlled endogenous stress regulation | 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. | ClinicalTrials.gov |
| Other | Daily life stress reactivity | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 6
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Emotional Stroop Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)