<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/NCT03836846</url>
  </required_header>
  <id_info>
    <org_study_id>029021</org_study_id>
    <nct_id>NCT03836846</nct_id>
  </id_info>
  <brief_title>Social Media Use in Adolescents Admitted to a Psychiatric Unit</brief_title>
  <official_title>Social Media Use in Adolescents Admitted to a Psychiatric Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaiser Permanente</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>
      We will investigate the association between social media use and depression in adolescents&#xD;
      admitted to a psychiatric unit and continue to follow their progress after discharge in&#xD;
      outpatient clinic services. We expect improvement in their depressive symptoms by modifying&#xD;
      social media use and adding a mental health app to further encourage the positive effects of&#xD;
      social media.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study was not initiated because it was not approved by KPSC IRB.&#xD;
  </why_stopped>
  <start_date type="Anticipated">October 1, 2019</start_date>
  <completion_date type="Anticipated">October 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2020</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>Comparing depression scale,PHQ9-A (Patient Health Questionnaire, Adolescent Version), with social media use</measure>
    <time_frame>1 month</time_frame>
    <description>Compare presence and severity of depressive symptoms in treatment as usual (TAU) group with TAU and the mobile app intervention group. The presence and severity of depression will be determined using the PHQ9-A (Patient Health Questionnaire, adolescent version), a 9-question depression scale that is based on the DSM-IV diagnostic criteria of depression and modified for teens to further inquire about other aspects of depression such as dysthymia, suicide risk, and other mental illnesses. The PHQ-9A scores each of the DSM-IV criteria as &quot;0&quot; (not at all) to &quot;3&quot; (nearly every day). Total depression severity score ranges of 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparing depression scale,PHQ9-A (Patient Health Questionnaire, Adolescent Version), with social media use</measure>
    <time_frame>3 months</time_frame>
    <description>Compare presence and severity of depressive symptoms in treatment as usual (TAU) group with TAU and the mobile app intervention group. The presence and severity of depression will be determined using the PHQ9-A (Patient Health Questionnaire, adolescent version), a 9-question depression scale that is based on the DSM-IV diagnostic criteria of depression and modified for teens to further inquire about other aspects of depression such as dysthymia, suicide risk, and other mental illnesses. The PHQ-9A scores each of the DSM-IV criteria as &quot;0&quot; (not at all) to &quot;3&quot; (nearly every day). Total depression severity score ranges of 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparing depression scale,PHQ9-A (Patient Health Questionnaire, Adolescent Version), with social media use</measure>
    <time_frame>6 months</time_frame>
    <description>Compare presence and severity of depressive symptoms in treatment as usual (TAU) group with TAU and the mobile app intervention group. The presence and severity of depression will be determined using the PHQ9-A (Patient Health Questionnaire, adolescent version), a 9-question depression scale that is based on the DSM-IV diagnostic criteria of depression and modified for teens to further inquire about other aspects of depression such as dysthymia, suicide risk, and other mental illnesses. The PHQ-9A scores each of the DSM-IV criteria as &quot;0&quot; (not at all) to &quot;3&quot; (nearly every day). Total depression severity score ranges of 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Depression</condition>
  <condition>Social Media</condition>
  <condition>Adolescent Behavior</condition>
  <arm_group>
    <arm_group_label>Treatment As Usual</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Standard of care as usual with follow-up at 1-, 3-, and 6-months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention with CBT Mobile App</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment as usual with additional treatment using cognitive behavioral therapy (CBT) mobile apps (ie What's Up?)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT Mobile App</intervention_name>
    <description>TAU and the additional treatment of a Mental Health App (What's Up?). This app will be used to guide adolescents through cognitive behavioral therapy and acceptance commitment therapy techniques, as well as to assist in developing coping mechanisms to prevent readmission.</description>
    <arm_group_label>Intervention with CBT Mobile App</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Treatment as usual</intervention_name>
    <description>TAU as per standard of care</description>
    <arm_group_label>Treatment As Usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants admitted to inpatient psychiatric unit&#xD;
&#xD;
          -  Kaiser insured participants between 13-17 years of age with parental consent&#xD;
&#xD;
          -  positive for social media use&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  non English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Canyon Ridge Hospital</name>
      <address>
        <city>Chino</city>
        <state>California</state>
        <zip>91710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.pewinternet.org/2018/05/31/teens-social-media-technology-2018/</url>
    <description>Teens, Social Media &amp; Technology 2018</description>
  </link>
  <link>
    <url>https://www.scie-socialcareonline.org.uk/statusofmind-social-media-and-young-peoples-mental-health-and-wellbeing/r/a110f00000NeITGAA3</url>
    <description>Social media and young people's mental health and wellbeing</description>
  </link>
  <reference>
    <citation>Pantic I. Online social networking and mental health. Cyberpsychol Behav Soc Netw. 2014 Oct;17(10):652-7. doi: 10.1089/cyber.2014.0070. Epub 2014 Sep 5.</citation>
    <PMID>25192305</PMID>
  </reference>
  <reference>
    <citation>Luxton DD, June JD, Fairall JM. Social media and suicide: a public health perspective. Am J Public Health. 2012 May;102 Suppl 2(Suppl 2):S195-200. doi: 10.2105/AJPH.2011.300608. Epub 2012 Mar 8.</citation>
    <PMID>22401525</PMID>
  </reference>
  <reference>
    <citation>Banos RM, Etchemendy E, Mira A, Riva G, Gaggioli A, Botella C. Online Positive Interventions to Promote Well-being and Resilience in the Adolescent Population: A Narrative Review. Front Psychiatry. 2017 Jan 30;8:10. doi: 10.3389/fpsyt.2017.00010. eCollection 2017.</citation>
    <PMID>28194117</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>January 6, 2022</last_update_submitted>
  <last_update_submitted_qc>January 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>All data will be collected by trained study personnel, and each study participant will be assigned a unique study number. Data will be de-identified after collection and hard copies of data will be stored in a locked cabinet in the investigator's office. We are considering options to share de-identified data.</ipd_description>
  </patient_data>
  <!-- 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/NCT03836846
org study id: 029021
nct id: NCT03836846
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
We will investigate the association between social media use and depression in adolescents
      admitted to a psychiatric unit and continue to follow their progress after discharge in
      outpatient clinic services. We expect improvement in their depressive symptoms by modifying
      social media use and adding a mental health app to further encourage the positive effects of
      social media.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Comparing depression scale,PHQ9-A (Patient Health Questionnaire, Adolescent Version), with social media use
time frame: 1 month
description: Compare presence and severity of depressive symptoms in treatment as usual (TAU) group with TAU and the mobile app intervention group. The presence and severity of depression will be determined using the PHQ9-A (Patient Health Questionnaire, adolescent version), a 9-question depression scale that is based on the DSM-IV diagnostic criteria of depression and modified for teens to further inquire about other aspects of depression such as dysthymia, suicide risk, and other mental illnesses. The PHQ-9A scores each of the DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Total depression severity score ranges of 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
measure: Comparing depression scale,PHQ9-A (Patient Health Questionnaire, Adolescent Version), with social media use
time frame: 3 months
description: Compare presence and severity of depressive symptoms in treatment as usual (TAU) group with TAU and the mobile app intervention group. The presence and severity of depression will be determined using the PHQ9-A (Patient Health Questionnaire, adolescent version), a 9-question depression scale that is based on the DSM-IV diagnostic criteria of depression and modified for teens to further inquire about other aspects of depression such as dysthymia, suicide risk, and other mental illnesses. The PHQ-9A scores each of the DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Total depression severity score ranges of 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
measure: Comparing depression scale,PHQ9-A (Patient Health Questionnaire, Adolescent Version), with social media use
time frame: 6 months
description: Compare presence and severity of depressive symptoms in treatment as usual (TAU) group with TAU and the mobile app intervention group. The presence and severity of depression will be determined using the PHQ9-A (Patient Health Questionnaire, adolescent version), a 9-question depression scale that is based on the DSM-IV diagnostic criteria of depression and modified for teens to further inquire about other aspects of depression such as dysthymia, suicide risk, and other mental illnesses. The PHQ-9A scores each of the DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Total depression severity score ranges of 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe.
arm group label: Treatment As Usual
arm group type: Placebo Comparator
description: Standard of care as usual with follow-up at 1-, 3-, and 6-months
arm group label: Intervention with CBT Mobile App
arm group type: Active Comparator
description: Treatment as usual with additional treatment using cognitive behavioral therapy (CBT) mobile apps (ie What's Up?)
intervention type: Behavioral
intervention name: CBT Mobile App
description: TAU and the additional treatment of a Mental Health App (What's Up?). This app will be used to guide adolescents through cognitive behavioral therapy and acceptance commitment therapy techniques, as well as to assist in developing coping mechanisms to prevent readmission.
arm group label: Intervention with CBT Mobile App
intervention type: Behavioral
intervention name: Treatment as usual
description: TAU as per standard of care
arm group label: Treatment As Usual
criteria: 
gender: All
minimum age: 13 Years
maximum age: 17 Years
healthy volunteers: No
facility: 
country: United States
url: http://www.pewinternet.org/2018/05/31/teens-social-media-technology-2018/
description: Teens, Social Media & Technology 2018
url: https://www.scie-socialcareonline.org.uk/statusofmind-social-media-and-young-peoples-mental-health-and-wellbeing/r/a110f00000NeITGAA3
description: Social media and young people's mental health and wellbeing
citation: Pantic I. Online social networking and mental health. Cyberpsychol Behav Soc Netw. 2014 Oct;17(10):652-7. doi: 10.1089/cyber.2014.0070. Epub 2014 Sep 5.
PMID: 25192305
citation: Luxton DD, June JD, Fairall JM. Social media and suicide: a public health perspective. Am J Public Health. 2012 May;102 Suppl 2(Suppl 2):S195-200. doi: 10.2105/AJPH.2011.300608. Epub 2012 Mar 8.
PMID: 22401525
citation: Banos RM, Etchemendy E, Mira A, Riva G, Gaggioli A, Botella C. Online Positive Interventions to Promote Well-being and Resilience in the Adolescent Population: A Narrative Review. Front Psychiatry. 2017 Jan 30;8:10. doi: 10.3389/fpsyt.2017.00010. eCollection 2017.
PMID: 28194117
responsible party type: Sponsor
mesh term: Depression
sharing ipd: Undecided
ipd description: All data will be collected by trained study personnel, and each study participant will be assigned a unique study number. Data will be de-identified after collection and hard copies of data will be stored in a locked cabinet in the investigator's office. We are considering options to share de-identified data.