<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/NCT04481425</url>
  </required_header>
  <id_info>
    <org_study_id>MD20200309</org_study_id>
    <nct_id>NCT04481425</nct_id>
  </id_info>
  <brief_title>Evaluation of the Efficacy of Non-drug Therapy (SMS Intervention) for Adolescents With NSSI</brief_title>
  <official_title>Evaluation of the Efficacy of Non-drug Therapy (SMS Intervention) for Adolescents With NSSI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central South University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central South University</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>
      In this proposed study, Text messages are used to intervene in the NSSI behavior of&#xD;
      adolescents, and the efficacy of this intervention method is evaluated, as well as the&#xD;
      internal mechanism of adolescents' NSSI behavior is discussed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this proposed study, the investigators will evaluate the effect of text message&#xD;
      intervention on Nonsuicidal self-injury behavior in adolescents. The study will recruit 110&#xD;
      adolescents with Nonsuicidal self-injury behavior in outpatient and ward, then all the&#xD;
      participants will be randomized to the intervention group (55 cases) or the control group 55&#xD;
      cases) for an 8-week clinic trial. Clinical efficacy and safety assessment will be done at&#xD;
      baseline, the fourth week, and the eighth week. The specific aims are to evaluate the effect&#xD;
      of text message intervention on NSSI in adolescents are on 1) Tendency and frequency of&#xD;
      Nonsuicidal self-injury behavior; 2) Level of negative emotion such as depression, anxiety,&#xD;
      and hopelessness 3) The use of emotion regulation strategies and coping styles. A&#xD;
      semi-structured quantitative interview will be conducted among adolescents from the SMS group&#xD;
      to get the attitude and experiences feedback about the text message.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 23, 2020</start_date>
  <completion_date type="Actual">January 30, 2022</completion_date>
  <primary_completion_date type="Actual">January 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change of NSSI behavior of the participants.</measure>
    <time_frame>At baseline, the fourth week, the eighth week</time_frame>
    <description>NSSI behavior will be measured by Nonsuicidal self-injury Questionnaire which contains several items designed by investigators. The questionnaire is mainly used to measure the frequency of NSSI among adolescents.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change of anxiety level.</measure>
    <time_frame>At baseline, the fourth week, the eighth week</time_frame>
    <description>The Generalized Anxiety Disorder 7-item Scale will be used to measure the change of anxiety. GAD-7 scale consists of 7 items. Each item ranging from 0 to 3, and the total score ranging from 0 to 21. The higher score indicates severe anxiety symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of depression level.</measure>
    <time_frame>At baseline, the fourth week, the eighth week</time_frame>
    <description>The Patient Health Questionnaire 9-item will be used to measure the change of depression. PHQ-9 scale consists of 9 items. Each item raging from 0 to 3, and the total score ranging from 0 to 27. The higher score indicates severe depression symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of hopelessness.</measure>
    <time_frame>At baseline, the fourth week, the eighth week</time_frame>
    <description>The Beck Hopelessness Scale will be used to measure the change of hopelessness. BHS scale consists of 20 items. Each item can be answered &quot;yes&quot; or &quot;no&quot; for 1 or 0 points respectively. The total score ranging from 0 to 20. A higher total score indicates a higher degree of hopelessness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of emotion regulation strategies.</measure>
    <time_frame>At baseline, the fourth week, the eighth week</time_frame>
    <description>The Emotion Regulation Questionnaire will be used to measure the change of emotion regulation styles. ERQ scale consists of 10 items which can be divided into cognitive reappraisal and expression suppression two emotion-regulating strategy subscales. Each item ranging from 1 to 7 points. The higher the score, the more often the respondent used this emotion-regulating strategy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of coping styles.</measure>
    <time_frame>At baseline, the fourth week, the eighth week</time_frame>
    <description>The Simplified Coping Style Questionnaire will be used to measure the change of coping styles. SCSQ scale consists of 20 items which can be divide into positive coping styles and negative coping styles in two dimensions. Each item raging from 0 to 3, and the total score ranging from 0 to 60. The higher the score, the more likely the respondents are to use this coping style.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of life events stress.</measure>
    <time_frame>At baseline, the fourth week, the eighth week</time_frame>
    <description>The Adolescent Self-Rating Life Events Check-list will be used to measure the frequency and intensity of life events that may trigger a stressful psychological response in adolescents. There are 27 items in the scale, which can be divided into 6 dimensions. The scale scores ranged from 27 to 135. The higher the score means the higher the degree of negative life event stress. The scale is widely used in China and has good reliability and validity.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Non-suicidal Self-injury</condition>
  <arm_group>
    <arm_group_label>intervention group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Text messages will be sent to the subjects through the investigator, including giving popularization of psychiatric knowledge, coping skills, emotional regulation strategies, and brief care. Two or three times a week for two months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects both collected in the outpatient department and the ward were randomly divided into the control group and regularly followed up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SMS intervention</intervention_name>
    <description>SMS intervention</description>
    <arm_group_label>intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adolescents aged 10-19 years old.&#xD;
&#xD;
          2. Meet the diagnostic criteria of NSSI behavior recommended by DSM-5.&#xD;
&#xD;
          3. The adolescents who have mobile phone, and have the ability to send or receive text&#xD;
             messages.&#xD;
&#xD;
          4. Adolescents and guardians agreed to participate and signed the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Adolescents with severe somatic diseases who cannot complete the study.&#xD;
&#xD;
          2. Adolescents with cognitive impairment, neurodevelopmental disorder, mental&#xD;
             retardation, visual impairment who cannot complete the study.&#xD;
&#xD;
          3. The adolescents who do not have a mobile phone.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jianjun Ou, doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Central South University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Runsen Chen, doctor</last_name>
    <role>Study Director</role>
    <affiliation>Central South University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Psychiatry, Xiangya Second Hospital, Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>November 17, 2022</last_update_submitted>
  <last_update_submitted_qc>November 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Central South University</investigator_affiliation>
    <investigator_full_name>Jian-Jun Ou</investigator_full_name>
    <investigator_title>Principal Investigator</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>


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/NCT04481425
org study id: MD20200309
nct id: NCT04481425
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In this proposed study, Text messages are used to intervene in the NSSI behavior of
      adolescents, and the efficacy of this intervention method is evaluated, as well as the
      internal mechanism of adolescents' NSSI behavior is discussed.
In this proposed study, the investigators will evaluate the effect of text message
      intervention on Nonsuicidal self-injury behavior in adolescents. The study will recruit 110
      adolescents with Nonsuicidal self-injury behavior in outpatient and ward, then all the
      participants will be randomized to the intervention group (55 cases) or the control group 55
      cases) for an 8-week clinic trial. Clinical efficacy and safety assessment will be done at
      baseline, the fourth week, and the eighth week. The specific aims are to evaluate the effect
      of text message intervention on NSSI in adolescents are on 1) Tendency and frequency of
      Nonsuicidal self-injury behavior; 2) Level of negative emotion such as depression, anxiety,
      and hopelessness 3) The use of emotion regulation strategies and coping styles. A
      semi-structured quantitative interview will be conducted among adolescents from the SMS group
      to get the attitude and experiences feedback about the text message.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The change of NSSI behavior of the participants.
time frame: At baseline, the fourth week, the eighth week
description: NSSI behavior will be measured by Nonsuicidal self-injury Questionnaire which contains several items designed by investigators. The questionnaire is mainly used to measure the frequency of NSSI among adolescents.
measure: The change of anxiety level.
time frame: At baseline, the fourth week, the eighth week
description: The Generalized Anxiety Disorder 7-item Scale will be used to measure the change of anxiety. GAD-7 scale consists of 7 items. Each item ranging from 0 to 3, and the total score ranging from 0 to 21. The higher score indicates severe anxiety symptoms.
measure: The change of depression level.
time frame: At baseline, the fourth week, the eighth week
description: The Patient Health Questionnaire 9-item will be used to measure the change of depression. PHQ-9 scale consists of 9 items. Each item raging from 0 to 3, and the total score ranging from 0 to 27. The higher score indicates severe depression symptoms.
measure: The change of hopelessness.
time frame: At baseline, the fourth week, the eighth week
description: The Beck Hopelessness Scale will be used to measure the change of hopelessness. BHS scale consists of 20 items. Each item can be answered "yes" or "no" for 1 or 0 points respectively. The total score ranging from 0 to 20. A higher total score indicates a higher degree of hopelessness.
measure: The change of emotion regulation strategies.
time frame: At baseline, the fourth week, the eighth week
description: The Emotion Regulation Questionnaire will be used to measure the change of emotion regulation styles. ERQ scale consists of 10 items which can be divided into cognitive reappraisal and expression suppression two emotion-regulating strategy subscales. Each item ranging from 1 to 7 points. The higher the score, the more often the respondent used this emotion-regulating strategy.
measure: The change of coping styles.
time frame: At baseline, the fourth week, the eighth week
description: The Simplified Coping Style Questionnaire will be used to measure the change of coping styles. SCSQ scale consists of 20 items which can be divide into positive coping styles and negative coping styles in two dimensions. Each item raging from 0 to 3, and the total score ranging from 0 to 60. The higher the score, the more likely the respondents are to use this coping style.
measure: The change of life events stress.
time frame: At baseline, the fourth week, the eighth week
description: The Adolescent Self-Rating Life Events Check-list will be used to measure the frequency and intensity of life events that may trigger a stressful psychological response in adolescents. There are 27 items in the scale, which can be divided into 6 dimensions. The scale scores ranged from 27 to 135. The higher the score means the higher the degree of negative life event stress. The scale is widely used in China and has good reliability and validity.
arm group label: intervention group
arm group type: Other
description: Text messages will be sent to the subjects through the investigator, including giving popularization of psychiatric knowledge, coping skills, emotional regulation strategies, and brief care. Two or three times a week for two months.
arm group label: control group
arm group type: No Intervention
description: Subjects both collected in the outpatient department and the ward were randomly divided into the control group and regularly followed up.
intervention type: Other
intervention name: SMS intervention
description: SMS intervention
arm group label: intervention group
criteria: 
gender: All
minimum age: 10 Years
maximum age: 19 Years
healthy volunteers: No
last name: Jianjun Ou, doctor
role: Study Chair
affiliation: Central South University
last name: Runsen Chen, doctor
role: Study Director
affiliation: Central South University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Central South University
investigator full name: Jian-Jun Ou
investigator title: Principal Investigator
mesh term: Self-Injurious Behavior