NCT05968313

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
14mo left

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Dec 2023Jul 2027

First Submitted

Initial submission to the registry

July 20, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

December 6, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

2.6 years

First QC Date

July 20, 2023

Last Update Submit

April 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

NSSI

HC

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Treatment-seeking NSSI individuals will be recruited from local hospitals and HC from the community

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sichuan Provincial Center for Mental Health, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Central Study Contacts

Benjamin Becker

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 20, 2023

First Posted

August 1, 2023

Study Start

December 6, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

April 11, 2024

Record last verified: 2024-04

Locations