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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • 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:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NSSI
Behavioral: Acceptance mindset
Brief training of acceptance versus emotional reactivity as emotion regulation strategy.
HC
Behavioral: Acceptance mindset
Brief training of acceptance versus emotional reactivity as emotion regulation strategy.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Electronic Science and Technology of China

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 6, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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