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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05981677
Other study ID # BAM_lab_NSSI_03
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, intentional physical injury without suicidal intention. Problematic interpersonal relationships and decision-making have been demonstrated to play crucial roles in this maladaptive behavior, especially for adolescents. Accumulating evidence suggests that decision processes and risk-taking are strongly influenced by the affective state of the individual. However, whether these interactions are disrupted in NSSI adolescents has not been systematically examined. In the current study, the investigators modified one of the most widely used paradigms for measuring an individual's risk decision-making, the Balloon Analogue Risk Task (BART). The investigators combine social reward (green balloon), punishment (red balloon), and control feedback (yellow balloon), to investigate whether the NSSI adolescents have dysfunctional risk-taking behavior while facing different social outcomes. The investigators recruit one group of NSSI adolescents (n = 40) and one health control (HC) group (n = 40), to compare their risk-related decisions during the emotional BART. The investigators hypothesize that compared to HC, NSSI adolescents will show altered effects of social reward and punishment on risk-related decision-making, in particular higher risk avoidance in the context of social punishment.


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


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 Risky avoidance measured by BART Adjusted number of pumps (average number of pumps excluding balloons that exploded) as the index of risk avoidance. Alterations in the patients will be determined by using ANOVA models with the group (NSSI vs. HC) as a between-subject factor and emotional feedback (social reward, social punishment, and control) as a within-subject factor. About 20 minutes
Primary Decision-making measured by BART Earned money (total amount of money earned in the task) as the index of decision-making. Alterations in the patients will be determined by using ANOVA models with the group (NSSI vs. HC) as a between-subject factor and emotional feedback (social reward, social punishment, and control) as a within-subject factor. About 20 minutes
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