Emotion Regulation Dysfunctions in NSSI Adolescents in Naturalistic Contexts

Emotion Regulation Clinical Trial

Official title:

Altered Neural Activation Patterns During Emotion Regulation in Adolescents With Nonsuicidal Self-Injury Under Naturalistic Immersive Emotional Engagement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05907421
• Other study ID #: BAM_lab_NSSI_01
• Status: Recruiting
• Start date: December 6, 2023
• Est. completion date: June 2027

Study information

• Verified date: April 2024
• Source: University of Electronic Science and Technology of China
• Contact: Benjamin Becker
• Phone: +86.028-61830867
• Email: ben_becker[@]gmx.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Emotion Regulation
• Nonsuicidal Self Injury
• Self-Injurious Behavior

Intervention

Behavioral:
• Acceptance mindset
Brief training of acceptance versus emotional reactivity as emotion regulation strategy.

Locations

Country	Name	City	State
China	Sichuan Provincial Center for Mental Health, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
University of Electronic Science and Technology of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative subjective emotional experience as indexed by self-report	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
Primary	Neural activity as indexed by BOLD fMRI	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