- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07513766
Emotion Regulation in RNT
The Neural Mechanisms of Emotion Dysregulation in Repetitive Negative Thinking (RNT) Patients: A Pilot Study
The goal of this study is to understand why some people become stuck in repetitive negative thinking, which is common among individuals with depression and anxiety. Repetitive negative thinking involves repeatedly focusing on negative events, worries, or problems. These thoughts can be difficult to control and may worsen emotional distress and daily functioning.
Researchers believe that repetitive negative thinking may be related to changes in how different brain networks communicate with each other. This study will examine how the brain responds during emotion regulation tasks in people who tend to ruminate compared with healthy individuals.
To do this, researchers will use a brain-imaging technique called functional near-infrared spectroscopy (fNIRS). This method measures brain activity using harmless infrared light while participants perform tasks on a computer.
The main questions this study aims to answer are:
How does the brain respond to emotional situations in people who experience repetitive negative thinking?
Are there differences in brain activity between people with depression or anxiety and healthy individuals during emotion regulation?
Participants will include 50 healthy volunteers and 50 individuals with depression or anxiety who experience repetitive negative thinking.
Participants will:
Wear a lightweight brain-imaging device (fNIRS) placed on the head to measure brain activity
Complete computer tasks involving emotional images and different emotion-regulation strategies, such as reinterpreting, suppressing, or distracting from emotions
Listen to different types of spoken feedback (criticism, praise, or neutral comments) and imagine receiving them from someone they know
Report their emotional feelings during the tasks
Complete several questionnaires about mood, thinking patterns, and emotional experiences
During the experiment, researchers will also record physiological responses such as heart activity and skin reactions, which are related to emotional responses.
The results of this study may help researchers better understand the brain mechanisms underlying rumination and may contribute to the development of more effective treatments for depression and anxiety.
Study Overview
Status
Detailed Description
Repetitive negative thinking (RNT), also known as rumination, is a key aspect of both depression and generalized anxiety disorder (GAD). RNT involves a pattern of repeated and uncontrollable negative thinking, often leaving individuals feeling trapped in a cycle of worrisome thoughts and gloomy ruminations. These cognitive processes can significantly impact both the emotional state and daily functioning of those suffering from it. In depression, RNT is often associated with constant rumination on negative events, past mistakes, and feelings of hopelessness. This repetitive and negative thinking often reinforces feelings of despondency and can further depress mood. In GAD, RNT manifests as persistent worry about numerous potential future dangers and problems, even when the actual threat is minimal.
RNT is considered an underlying mechanism involved in several psychiatric disorders. RNT not only amplifies the intensity of negative emotions but can also contribute to the duration and severity of psychological symptoms. Addressing RNT is increasingly recognized as a crucial target for both future research and clinical interventions. By better understanding the complex relationship between rumination and mental health disorders, we can not only elucidate the onset and progression of these disorders but also develop more targeted treatments aimed at disrupting the negative thinking patterns that characterize RNT.
Research has demonstrated abnormal neuronal activity in people with depression or GAD who also experience RNT. Previous studies using functional magnetic resonance imaging (fMRI) have demonstrated atypical functional connectivity (FC) and brain activity in specific regions of the Central Executive Network (CEN), the default mode network (DMN), and the Salience Network (SN) during computer-based tasks measuring emotion regulation in individuals with depression and GAD, compared to healthy controls.
For this reason, the focus of our research is on identifying the specific neural, cognitive, and emotional mechanisms that fuel and maintain rumination.
A promising approach for this research is Functional Near-Infrared Spectroscopy (fNIRS), an optical brain imaging technique that uses infrared light for functional neuroimaging. fNIRS measures brain activity by detecting shifts in the concentrations of oxidized and deoxidized hemoglobin, making it one of the most widely used non-invasive neuroimaging methods with remarkable temporal resolution. The primary goal of this study is to investigate differential brain responses during emotion regulation tasks in patients with RNT compared to healthy controls using fNIRS.
The research group will include both healthy controls (n = 50) and individuals with depression and anxiety who exhibit tendencies toward RNT (n = 50). The fNIRS device will be placed on the participants' heads to record brain activity, while two experimental paradigms will be used simultaneously to investigate emotion regulation: 1) Emotion Regulation Task; 2) Criticism Paradigm.
The Emotion Regulation Task initially involves two conditions: simple presentation of neutral images ("neutral viewing") and simple presentation of negative images ("negative viewing"). These conditions are presented sequentially, with the goal of measuring the engagement of the cognitive control network during emotional responses. Participants receive on-screen prompts before beginning each task in each condition. At this stage, a "Look" prompt is presented, asking participants to notice their feelings toward the neutral or negative image and respond naturally. At the end of each trial, participants are asked to rate their emotions at that moment. Additionally, the study includes three emotion regulation conditions, randomly assigned to each participant: positive reappraisal of negative images ("positive reappraisal"), suppression of feelings toward negative images ("suppression"), and distraction from negative images ("distraction"). For the "Reappraisal" prompt, participants are asked to reinterpret aversive images by creating a story to make the images less negative or even more positive. In the "Distraction" prompt, participants are asked to quickly determine whether a given mathematical equation hovering over negative images is correct or incorrect by pressing a button. In the "Suppression" prompt, , participants are expected to suppress their emotions regarding the image.
The Criticism paradigm involves participants listening to a series of auditory comments while focusing their gaze on a fixation cross displayed on a computer screen. These comments comprise three emotional tones: negative (criticism), positive (praise), and neutral. Each comment lasts 30 seconds and is alternated with 30 seconds of silence. All participants are exposed to the same comments and instructed to imagine that they are listening to someone who knows them very well. This section begins with two neutral comments, followed by two positive comments, and concludes with another two neutral comments followed by two negative comments.
Resting-state measurements are also performed before and after the emotion regulation task and the criticism paradigm.
Resting-state measurements are also performed before and after the emotion regulation task and the criticism paradigm.
During the computer task and resting state measurement, we collect physiological data regarding heart and skin functions. This includes measuring heart rate (ECG), cardiac activity (ICG), and skin reactions (SCR). These physiological measurements are linked to emotion regulation.
In addition, participants' behavioral measurements are assessed using various questionnaires, including demographic data, MINI-screening, HDRS (for patients only), PC, VAS-emotion, MAIA, BDI, STAI, PSWQ, LARSS, RRS, CERQ, PTQ, self-critical rumination.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Chris Baeken
- Phone Number: +32476209841
- Email: Chris.Baeken@ugent.be
Study Contact Backup
- Name: Sara De Witte
- Phone Number: +32498382824
- Email: sara.dewitte@ugent.be
Study Locations
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Ghent, Belgium, 9000
- Recruiting
- University Hospital Ghent, Ghent, East-Flanders 9000
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Contact:
- Chris Baeken
- Phone Number: +32476209841
- Email: Chris.Baeken@ugent.be
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Contact:
- Sara De Witte
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient group: diagnosis of depression/GAD
- Healthy control group: no history of or current form of psychopathology
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patient group
People who have a current or past history of anxiety and/or depression
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Healthy control group
People who do not have a current or past history of anxiety and/or depression
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Perseverative Thinking Questionnaire (PTQ) total score
Time Frame: During a single laboratory session (baseline assessment)
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The Perseverative Thinking Questionnaire (PTQ) total score will be used to assess repetitive negative thinking at baseline.
Baseline PTQ total scores will be compared between patients and healthy controls.
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During a single laboratory session (baseline assessment)
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Penn State Worry Questionnaire (PSWQ) score
Time Frame: During a single laboratory session (baseline assessment)
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The Penn State Worry Questionnaire (PSWQ) total score will be used to assess worry at baseline.
Baseline PSWQ total scores will be compared between patients and healthy controls
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During a single laboratory session (baseline assessment)
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Leuven Adaptation of the Rumination on Sadness Scale (LARSS) score
Time Frame: During a single laboratory session (baseline assessment)
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The Leuven Adaptation of the Rumination on Sadness Scale (LARSS) score will be used to assess rumination at baseline.
Baseline LARSS total scores will be compared between patients and healthy controls.
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During a single laboratory session (baseline assessment)
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Ruminative Responses Scale (RRS) score
Time Frame: During a single laboratory session (baseline assessment)
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The Ruminative Responses Scale (RRS) score will be used to assess rumination at baseline.
Baseline RRS total scores will be compared between patients and healthy controls.
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During a single laboratory session (baseline assessment)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mean task-evoked oxygenated hemoglobin (HbO) changes in cortical regions-mainly the dorsolateral prefrontal cortex and precuneus-during the emotion regulation task, as measured by fNIRS.
Time Frame: During a single laboratory session (baseline assessment)
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Functional near-infrared spectroscopy (fNIRS) will be used to measure task-evoked changes in oxygenated (HbO), deoxygenated (HbR), and total hemoglobin (HbT) in predefined prefrontal cortical regions during the emotion regulation task.
For each participant, mean HbO, HbR, and HbT changes will be calculated across task blocks and compared between patients and healthy controls at baseline.
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During a single laboratory session (baseline assessment)
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Mean task-evoked oxygenated hemoglobin (HbO) change in prefrontal cortical regions during the critical paradigm measured by fNIRS
Time Frame: During a single laboratory session (baseline assessment)
|
Functional near-infrared spectroscopy (fNIRS) will be used to measure task-evoked changes in oxygenated hemoglobin (HbO) in predefined prefrontal cortical regions during the critical paradigm.
For each participant, mean HbO changes will be calculated across task blocks and compared between patients and healthy controls at baseline.
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During a single laboratory session (baseline assessment)
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Mean resting-state functional connectivity in prefrontal cortical regions measured by fNIRS
Time Frame: During a single laboratory session (baseline assessment)
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Resting-state functional near-infrared spectroscopy (fNIRS) data will be used to assess functional connectivity in predefined prefrontal cortical regions.
For each participant, mean resting-state functional connectivity values will be calculated from resting-state recordings and compared between patients and healthy controls at baseline.
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During a single laboratory session (baseline assessment)
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Mean heart rate during experimental tasks measured by electrocardiography (ECG)
Time Frame: During a single laboratory session (baseline assessment)
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Electrocardiography (ECG) will be used to assess heart rate during the experimental tasks.
For each participant, mean heart rate will be calculated across task periods and compared between patients and healthy controls at baseline.
|
During a single laboratory session (baseline assessment)
|
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Mean skin conductance response amplitude during experimental tasks measured by skin conductance recording (SCR)
Time Frame: During a single laboratory session (baseline assessment)
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Skin conductance recording (SCR) will be used to assess autonomic arousal during the experimental tasks.
For each participant, mean skin conductance response amplitude will be calculated across task periods and compared between patients and healthy controls at baseline.
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During a single laboratory session (baseline assessment)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chris Baeken, University Ghent
Publications and helpful links
General Publications
- Morawetz C, Riedel MC, Salo T, Berboth S, Eickhoff SB, Laird AR, Kohn N. Multiple large-scale neural networks underlying emotion regulation. Neurosci Biobehav Rev. 2020 Sep;116:382-395. doi: 10.1016/j.neubiorev.2020.07.001. Epub 2020 Jul 11.
- Fitzgerald JM, Klumpp H, Langenecker S, Phan KL. Transdiagnostic neural correlates of volitional emotion regulation in anxiety and depression. Depress Anxiety. 2019 May;36(5):453-464. doi: 10.1002/da.22859. Epub 2018 Nov 8.
- Demichelis OP, Grainger SA, Hubbard RE, Henry JD. Emotion regulation mediates the relationship between social frailty and stress, anxiety, and depression. Sci Rep. 2023 Apr 20;13(1):6430. doi: 10.1038/s41598-023-33749-0.
- Watkins ER, Roberts H. Reflecting on rumination: Consequences, causes, mechanisms and treatment of rumination. Behav Res Ther. 2020 Apr;127:103573. doi: 10.1016/j.brat.2020.103573. Epub 2020 Jan 31.
- Spinhoven P, van Hemert AM, Penninx BW. Repetitive negative thinking as a predictor of depression and anxiety: A longitudinal cohort study. J Affect Disord. 2018 Dec 1;241:216-225. doi: 10.1016/j.jad.2018.08.037. Epub 2018 Aug 10.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ONZ-2023-0459
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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