NCT05907421

Brief 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).

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
13mo 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 Progress69%
Dec 2023Jun 2027

First Submitted

Initial submission to the registry

June 7, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

December 6, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

2.5 years

First QC Date

June 7, 2023

Last Update Submit

April 9, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

NSSI

Behavioral: Acceptance mindset

HC

Behavioral: Acceptance mindset

Interventions

Brief training of acceptance versus emotional reactivity as emotion regulation strategy.

HCNSSI

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 BehaviorEmotional Regulation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSelf-ControlSocial Behavior

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

June 7, 2023

First Posted

June 18, 2023

Study Start

December 6, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

April 11, 2024

Record last verified: 2024-04

Locations