- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05981677
Social Feedback and Dysfunctional Risk Taking in NSSI Adolescents
April 9, 2024 updated by: Benjamin Becker, University of Electronic Science and Technology of China
Risk and Social Feedback in Adolescents With Nonsuicidal Self-Injury
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Benjamin Becker
- Phone Number: +86.028-61830867
- Email: ben_becker@gmx.de
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China
- Recruiting
- Sichuan Provincial Center for Mental Health, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China
-
Contact:
- Lyuan Li
- Email: lly_psychology@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Treatment-seeking NSSI individuals will be recruited from local hospitals and HC from the community.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
NSSI
|
|
HC
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risky avoidance measured by BART
Time Frame: About 20 minutes
|
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
|
|
Decision-making measured by BART
Time Frame: About 20 minutes
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 6, 2023
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2027
Study Registration Dates
First Submitted
July 20, 2023
First Submitted That Met QC Criteria
August 4, 2023
First Posted (Actual)
August 8, 2023
Study Record Updates
Last Update Posted (Actual)
April 11, 2024
Last Update Submitted That Met QC Criteria
April 9, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BAM_lab_NSSI_03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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