- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05907421
Emotion Regulation Dysfunctions in NSSI Adolescents in Naturalistic Contexts
April 9, 2024 updated by: Benjamin Becker, University of Electronic Science and Technology of China
Altered Neural Activation Patterns During Emotion Regulation in Adolescents With Nonsuicidal Self-Injury Under Naturalistic Immersive Emotional Engagement
Nonsuicidal self-injury (NSSI) is defined as direct, deliberate bodily harm without suicidal intention.
Recent studies indicate that prevalence rates are increasing worldwide, in particular under adolescents, indicating a growing public health issue.
An impaired ability to regulate negative emotion has been suggested to play a potential role in NSSI behavior.
Some recent interventions aim at improving dysfunctional emotion regulation via 'acceptance'.
Acceptance represents an objective, nonreactive, nonjudgmental, and calming emotion regulation strategy, partly based on the philosophy of dialectical behavior therapy (DBT) that has been widely used in the clinical treatment of NSSI behaviors.
The aim of the present functional magnetic resonance imaging (fMRI) study is to examine whether adolescents with NSSI can implement the acceptance strategy in naturalistic emotional contexts (immersive video clips) and whether they differ from healthy controls in terms of behavioral and neural effects.
To this end, the investigators recruit one group of NSSI adolescents (n=40) and one healthy control group (n=40), to compare the subjective emotional experience as well as underlying neural activity as measured by blood oxygenation level-dependent (BOLD) fMRI.
The investigators hypothesize that compared to HC, NSSI adolescents will experience stronger negative emotions and show dysregulated neural recruitment of brain systems engaged in emotional reactivity and regulations (e.g.
limbic regions, default mode network, and frontal regions).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Benjamin Becker
- Phone Number: +86.028-61830867
- Email: ben_becker@gmx.de
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China
- Recruiting
- Sichuan Provincial Center for Mental Health, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China
-
Contact:
- Lyuan Li
- Email: lly_psychology@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Treatment-seeking NSSI individuals will be recruited from local hospitals and HC from the community.
Description
Inclusion Criteria:
- 15-18 years
- right-handed
- normal or corrected normal visual acuity
- meet the proposed DSM-5 frequency criteria (e.g., ≥5 days of NSSI behaviors in the past year)
Exclusion Criteria:
- diagnosis of borderline personality disorder, major depressive disorder, other psychiatric disorders, etc.
- high suicidal risk
- recent use of medications that can affect neural activity
- have received or are receiving Dialectical Behavior Therapy (DBT) other treatment for emotional problems within the past 6 months
- have a contraindication to MRI scanning (e.g., metal implants, claustrophobia or other conditions that make them inappropriate for MRI scanning)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
NSSI
|
Brief training of acceptance versus emotional reactivity as emotion regulation strategy.
|
HC
|
Brief training of acceptance versus emotional reactivity as emotion regulation strategy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Negative subjective emotional experience as indexed by self-report
Time Frame: About 30 minutes
|
Subjects will rate their negative affect on a scale ranging from 1-9 in response to neutral and negative emotional stimuli during normal experience or acceptance.
Alterations in the patients will be determined by using ANOVA models with the group (NSSI vs. HC) as a between-subject factor and emotion regulation condition as a within-subject factor.
|
About 30 minutes
|
Neural activity as indexed by BOLD fMRI
Time Frame: About 30 minutes
|
Brain activity will be monitored by task-based fMRI.
Alterations in the patients will be determined by the experimental groups (NSSI vs. HC) with respect to the emotion regulation conditions.
|
About 30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 6, 2023
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2027
Study Registration Dates
First Submitted
June 7, 2023
First Submitted That Met QC Criteria
June 7, 2023
First Posted (Actual)
June 18, 2023
Study Record Updates
Last Update Posted (Actual)
April 11, 2024
Last Update Submitted That Met QC Criteria
April 9, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAM_lab_NSSI_01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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