xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05981677</url>
    </required_header>
    <id_info>
      <org_study_id>BAM_lab_NSSI_03</org_study_id>
      <nct_id>NCT05981677</nct_id>
    </id_info>
    <brief_title>Social Feedback and Dysfunctional Risk Taking in NSSI Adolescents</brief_title>
    <official_title>Risk and Social Feedback in Adolescents With Nonsuicidal Self-Injury</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Electronic Science and Technology of China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Electronic Science and Technology of China</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Nonsuicidal self-injury (NSSI) is defined as direct, intentional physical injury without&#xD;
        suicidal intention. Problematic interpersonal relationships and decision-making have been&#xD;
        demonstrated to play crucial roles in this maladaptive behavior, especially for adolescents.&#xD;
        Accumulating evidence suggests that decision processes and risk-taking are strongly&#xD;
        influenced by the affective state of the individual. However, whether these interactions are&#xD;
        disrupted in NSSI adolescents has not been systematically examined. In the current study, the&#xD;
        investigators modified one of the most widely used paradigms for measuring an individual's&#xD;
        risk decision-making, the Balloon Analogue Risk Task (BART). The investigators combine social&#xD;
        reward (green balloon), punishment (red balloon), and control feedback (yellow balloon), to&#xD;
        investigate whether the NSSI adolescents have dysfunctional risk-taking behavior while facing&#xD;
        different social outcomes. The investigators recruit one group of NSSI adolescents (n = 40)&#xD;
        and one health control (HC) group (n = 40), to compare their risk-related decisions during&#xD;
        the emotional BART. The investigators hypothesize that compared to HC, NSSI adolescents will&#xD;
        show altered effects of social reward and punishment on risk-related decision-making, in&#xD;
        particular higher risk avoidance in the context of social punishment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">July 2027</completion_date>
    <primary_completion_date type="Anticipated">July 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Risky avoidance measured by BART</measure>
      <time_frame>About 20 minutes</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Decision-making measured by BART</measure>
      <time_frame>About 20 minutes</time_frame>
      <description>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.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Nonsuicidal Self Injury</condition>
    <condition>Risk-Taking</condition>
    <arm_group>
      <arm_group_label>NSSI</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>HC</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Treatment-seeking NSSI individuals will be recruited from local hospitals and HC from the&#xD;
          community.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  15-18 years&#xD;
  &#xD;
            -  right-handed&#xD;
  &#xD;
            -  normal or corrected normal visual acuity&#xD;
  &#xD;
            -  meet the proposed DSM-5 frequency criteria (e.g., ≥5 days of NSSI behaviors in the&#xD;
               past year)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  diagnosis of borderline personality disorder, major depressive disorder, other&#xD;
  &#xD;
            -  psychiatric disorders, etc.&#xD;
  &#xD;
            -  high suicidal risk&#xD;
  &#xD;
            -  recent use of medications that can affect neural activity&#xD;
  &#xD;
            -  have received or are receiving Dialectical Behavior Therapy (DBT) other treatment for&#xD;
               emotional problems within the past 6 months&#xD;
  &#xD;
            -  have a contraindication to MRI scanning (e.g., metal implants, claustrophobia or other&#xD;
               conditions that make them inappropriate for MRI scanning)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Benjamin Becker</last_name>
      <phone>+86.028-61830867</phone>
      <email>ben_becker@gmx.de</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Electronic Science and Technology of China</investigator_affiliation>
      <investigator_full_name>Benjamin Becker</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Self-Injurious Behavior</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05981677
  org study id: BAM_lab_NSSI_03
  nct id: NCT05981677
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Risky avoidance measured by BART
  time frame: About 20 minutes
  description: 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.
  measure: Decision-making measured by BART
  time frame: About 20 minutes
  description: 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.
  arm group label: NSSI
  arm group label: HC
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 18 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Benjamin Becker
  phone: +86.028-61830867
  email: ben_becker@gmx.de
  responsible party type: Principal Investigator
  investigator affiliation: University of Electronic Science and Technology of China
  investigator full name: Benjamin Becker
  investigator title: Professor
  mesh term: Self-Injurious Behavior