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/NCT05981612</url>
    </required_header>
    <id_info>
      <org_study_id>BAM_lab_NSSI_04</org_study_id>
      <nct_id>NCT05981612</nct_id>
    </id_info>
    <brief_title>Impact of Emotional Reactivity on Dysfunctional Decision-Making in NSSI Adolescents</brief_title>
    <official_title>Effects of Emotional Reactivity on Decision-Making 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. Studies revealed that dysfunctional interpersonal relationships and&#xD;
        reward-related decision-making may play crucial roles in this maladaptive behavior,&#xD;
        especially in adolescents. These interpersonal decision contexts are characterized by&#xD;
        constant updating of expectations of rewards and the actual received rewards as well as the&#xD;
        associated emotional reactions. These processes have recently been computationally formalized&#xD;
        as prediction errors (PE), specifically reward PEs, valence PEs, and arousal PEs (Heffner et&#xD;
        al., 2021; Nat Hum Behav). In the current study, the investigators aim to investigate whether&#xD;
        these PEs make discernible contributions to social decisions in the context of unfair&#xD;
        experiences among adolescents with NSSI and matched healthy control adolescents (HC).&#xD;
        Specifically the investigators hypothesized that: 1) reward and emotional PEs show&#xD;
        significant predictions of punishment decisions in both groups, 2) however, compared to HC&#xD;
        adolescents, the NSSI group will exhibit selective dysfunctions in emotional but not reward&#xD;
        PEs leading to punish a norm proposer who provided unfair offers.&#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>Reward prediction errors (PEs)</measure>
      <time_frame>About 20 minutes</time_frame>
      <description>Reward PEs will be calculated by the differences between the experienced (when be offered) reward and predicted (before the offer) reward.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Valence prediction errors (PEs)</measure>
      <time_frame>About 20 minutes</time_frame>
      <description>Valence PEs will be calculated by the differences between the experienced emotional valence and predicted emotional valence.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Arousal prediction errors (PEs)</measure>
      <time_frame>About 20 minutes</time_frame>
      <description>Arousal PEs will be calculated by the differences between the experienced emotional arousal and predicted emotional arousal.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The prediction of PEs of punishment decisions</measure>
      <time_frame>About 20 minutes</time_frame>
      <description>All PEs and groups (NSSI, HC) will be used in a regression model to examined whether there is any alteration in the NSSI group when PEs are predicted to punishment (reject) decisions.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Nonsuicidal Self Injury</condition>
    <condition>Prediction Errors</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>
    </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/NCT05981612
  org study id: BAM_lab_NSSI_04
  nct id: NCT05981612
  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. Studies revealed that dysfunctional interpersonal relationships and
        reward-related decision-making may play crucial roles in this maladaptive behavior,
        especially in adolescents. These interpersonal decision contexts are characterized by
        constant updating of expectations of rewards and the actual received rewards as well as the
        associated emotional reactions. These processes have recently been computationally formalized
        as prediction errors (PE), specifically reward PEs, valence PEs, and arousal PEs (Heffner et
        al., 2021; Nat Hum Behav). In the current study, the investigators aim to investigate whether
        these PEs make discernible contributions to social decisions in the context of unfair
        experiences among adolescents with NSSI and matched healthy control adolescents (HC).
        Specifically the investigators hypothesized that: 1) reward and emotional PEs show
        significant predictions of punishment decisions in both groups, 2) however, compared to HC
        adolescents, the NSSI group will exhibit selective dysfunctions in emotional but not reward
        PEs leading to punish a norm proposer who provided unfair offers.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Reward prediction errors (PEs)
  time frame: About 20 minutes
  description: Reward PEs will be calculated by the differences between the experienced (when be offered) reward and predicted (before the offer) reward.
  measure: Valence prediction errors (PEs)
  time frame: About 20 minutes
  description: Valence PEs will be calculated by the differences between the experienced emotional valence and predicted emotional valence.
  measure: Arousal prediction errors (PEs)
  time frame: About 20 minutes
  description: Arousal PEs will be calculated by the differences between the experienced emotional arousal and predicted emotional arousal.
  measure: The prediction of PEs of punishment decisions
  time frame: About 20 minutes
  description: All PEs and groups (NSSI, HC) will be used in a regression model to examined whether there is any alteration in the NSSI group when PEs are predicted to punishment (reject) decisions.
  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
  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