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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05968313
Other study ID # BAM_lab_NSSI_02
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 6, 2023
Est. completion date July 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
Health authority
Study type Observational

Clinical Trial Summary

Nonsuicidal self-injury (NSSI) is defined as direct, deliberate bodily harm without suicidal intention. In recent years, growing evidence suggests that NSSI has become a worldwide public health issue. People with NSSI behaviors, especially adolescents, commonly exhibit emotion-related and interpersonal problems. Pain empathy represents an essential basal domain of socio-emotional processing and refers to the ability to empathize, connect and share with others' pain. However, altered empathic processing has not been systematically examined in adolescents with NSSI. To this end, the current functional magnetic resonance imaging (fMRI) study will recruit one group of NSSI adolescents (n=40) and one healthy control (HC) group (n=40), to compare their neural activity regarding pain empathy processing, which is measured by blood oxygenation level-dependent (BOLD) fMRI. The investigators included conditions of physical pain empathy (stimuli depicting noxious stimulation to the limbs) and affective pain empathy (stimuli depicting faces expressing pain) as well as corresponding control stimuli. The investigators hypothesize that compared to HC, NSSI adolescents show increased empathic reactivity to physical pain stimuli in salience and arousal related brain regions but decreased empathic reactivity to affective pain empathic stimuli.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date July 2027
Est. primary completion date July 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)

Study Design


Related Conditions & MeSH terms


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 Neural activity as indexed by BOLD fMRI Brain activity will be monitored by task-based fMRI. The paradigm will present affective and physical pain empathy pictures and matched control stimuli. Alterations in the patients will be determined by comparing neural activity to the experimental conditions between the experimental groups (NSSI vs. HC) using ANOVA models. About 8 minutes
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