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/NCT06033391</url>
    </required_header>
    <id_info>
      <org_study_id>2557724</org_study_id>
      <nct_id>NCT06033391</nct_id>
    </id_info>
    <brief_title>Mobile App for Obsessive-compulsive Disorder in Adolescents</brief_title>
    <official_title>Promoting Mental Health in Adolescents Through Mobile Apps: the Case of Obsessive-compulsive Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Valencia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Ministry of Science and Innovation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Valencia</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the present study is to assess the efficacy of the module GGOC-AD (GG&#xD;
        Obsessive-Compulsive Disorder - Adolescents) in reducing obsessive-compulsive disorder (OCD)&#xD;
        related maladaptive beliefs and OCD symptoms in adolescents from 15 to 18 years old.&#xD;
        Specifically, a randomized controlled trial with two conditions (experimental and control)&#xD;
        will be carried out in a non-clinical adolescent population to assess pre-post-intervention&#xD;
        changes. After 14 days of using GGOC-AD, it is expected, primarily, to find a decrease in&#xD;
        OCD-related maladaptive beliefs and OCD symptoms. As secondary results, we do not expect&#xD;
        changes in emotional symptomatology, but we do expect an increase in self-esteem.&#xD;
        Additionally, these changes are expected to be found in a one-month follow-up.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pediatric OCD is a serious problem and, if not treated early on, is associated with&#xD;
        significant impairment. The app GGOC, aimed at working on OCD-related dysfunctional beliefs&#xD;
        in adults, has proven in previous studies in adult clinical and non-clinical samples, to&#xD;
        significantly decrease maladaptive beliefs associated with OCD and obsessive-compulsive&#xD;
        symptomatology. Also, it can significantly increase self-esteem. Therefore, it is relevant to&#xD;
        adapt the GGOC application to the adolescent population (GGOC-AD) and evaluate its&#xD;
        effectiveness.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 18, 2023</start_date>
    <completion_date type="Anticipated">November 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</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>
      <intervention_model_description>Participants that meet the inclusion criteria will complete the web-based baseline assessment (pre), with questionnaires relating to maladaptive beliefs, mood (anxiety and depressions), self-esteem and OCD symptoms. After, experimental group will use the GGOC-AD, and control group will use the GGN-AD for 14 days. Then, both groups will complete again the above-mentioned assessment instruments (post use of the app). Finally, all participants will complete the follow-up measures at one month.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in obsessive beliefs</measure>
      <time_frame>Through app completion (14 days) and 1 month follow-up</time_frame>
      <description>Score change in obsessive compulsive maladaptive beliefs measured by the Obsessive Beliefs Questionnaire-Child Version (OBQ-CV). Total score is computed as a mean of the 44 items, ranging from 0 &quot;strongly disagree&quot; to 4 &quot;strongly agree&quot;. Higher scores indicate the person has more obsessive beliefs.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in obsessive-compulsive symptomatology</measure>
      <time_frame>Through app completion (14 days) and 1 month follow-up</time_frame>
      <description>Score change in obsessive-compulsive symptoms measured by the Obsessive Compulsive Inventory- Child Version (OCI-R-CV). Total score is computed as a mean of the 21 items, ranging from 0 &quot;never&quot; to 2 &quot;always&quot;. Higher scores indicate a greater presence of obsessive-compulsive symptoms.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>No change in emotional symptoms</measure>
      <time_frame>Through app completion (14 days) and 1 month follow-up</time_frame>
      <description>No changes in depression and anxiety symptoms measured by The Patient Health Questionnaire for Depression and Anxiety (PH-4). It consists of 4 items, two for Anxiety and two for Depression, with a 4-point Likert scale (from 0 = &quot;never&quot; to 3 = &quot;almost every day&quot;). Higher scores indicate a greater presence of depression or anxiety symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in self-esteem</measure>
      <time_frame>Through app completion (14 days) and 1 month follow-up</time_frame>
      <description>Change in score of Single Item Self Esteem Scale (SISE). Self-Esteem is measured with this single item ranging from 1 &quot;It is not very true for me&quot; to 7 &quot;It is very true for me&quot;. Higher scores indicate a higher self-esteem.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Obsessive-Compulsive Disorder in Adolescence</condition>
    <arm_group>
      <arm_group_label>GGOC-AD (GG Obsessive-Compulsive Disorder - Adolescents)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The experimental group will use the GGOC-AD module for 14 days after the first assessment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>GGN-AD (GG Neutral - Adolescents)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The control group will use the GGN-AD module for 14 days after the first assessment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>GGOC-AD (GG Obsessive-Compulsive Disorder - Adolescents)</intervention_name>
      <description>GGOC was originally designed to challenge maladaptive beliefs that underline OCD symptoms in adult population. It was adapted to adolescent population. It consists of statements that are presented to the user, and that can portray either negative (&quot;I can't trust myself&quot;) or positive beliefs (&quot;I have a lot of good characteristics&quot;). Users have to respond by either pulling these towards &quot;Accept&quot; or &quot;Reject&quot;.</description>
      <arm_group_label>GGOC-AD (GG Obsessive-Compulsive Disorder - Adolescents)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>GGN-AD (GG Neutral - Adolescents)</intervention_name>
      <description>it was designed to have a comparison group. It consists of neutral statements such as &quot;Madrid is a Spanish city&quot;, that ought not to produce changes in the direction of our hypothesis. These have to be &quot;Accepted&quot; or &quot;Rejected&quot; based on their veracity.</description>
      <arm_group_label>GGN-AD (GG Neutral - Adolescents)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. To have signed the informed consent, both the adolescents and their parents or legal&#xD;
               guardians.&#xD;
  &#xD;
            2. For the children to be within the established age range.&#xD;
  &#xD;
            3. To have a mobile phone (indistinctly Android or iOS mobile system) with Internet&#xD;
               access.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gemma García-Soriano</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Valencia</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gemma García-Soriano</last_name>
      <phone>+34 963983389</phone>
      <email>gemma.garcia@uv.es</email>
    </overall_contact>
    <link>
      <url>https://play.google.com/store/apps/details?id=air.com.samuramu.gg.oc</url>
      <description>Link to download the app from Google Play</description>
    </link>
    <reference>
      <citation>Roncero M, Belloch A, Doron G. Can Brief, Daily Training Using a Mobile App Help Change Maladaptive Beliefs? Crossover Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Feb 13;7(2):e11443. doi: 10.2196/11443.</citation>
      <PMID>30758294</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Valencia</investigator_affiliation>
      <investigator_full_name>Gemma García-Soriano</investigator_full_name>
      <investigator_title>PhD, associate professor</investigator_title>
    </responsible_party>
    <keyword>obsessive-compulsive disorder</keyword>
    <keyword>cognitive therapy</keyword>
    <keyword>maladaptive beliefs</keyword>
    <keyword>mobile app</keyword>
    <keyword>adolescence</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Compulsive Personality Disorder</mesh_term>
      <mesh_term>Obsessive-Compulsive Disorder</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Share all IPD that underlie results in a publication.</ipd_description>
      <ipd_time_frame>It will be available for 3 months after the publication of the study.</ipd_time_frame>
      <ipd_access_criteria>Data will be available in the repository website of the University of Valencia.</ipd_access_criteria>
      <ipd_url>http://roderic.uv.es/</ipd_url>
    </patient_data>
    <!-- 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/NCT06033391
  org study id: 2557724
  nct id: NCT06033391
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the present study is to assess the efficacy of the module GGOC-AD (GG
        Obsessive-Compulsive Disorder - Adolescents) in reducing obsessive-compulsive disorder (OCD)
        related maladaptive beliefs and OCD symptoms in adolescents from 15 to 18 years old.
        Specifically, a randomized controlled trial with two conditions (experimental and control)
        will be carried out in a non-clinical adolescent population to assess pre-post-intervention
        changes. After 14 days of using GGOC-AD, it is expected, primarily, to find a decrease in
        OCD-related maladaptive beliefs and OCD symptoms. As secondary results, we do not expect
        changes in emotional symptomatology, but we do expect an increase in self-esteem.
        Additionally, these changes are expected to be found in a one-month follow-up.
  Pediatric OCD is a serious problem and, if not treated early on, is associated with
        significant impairment. The app GGOC, aimed at working on OCD-related dysfunctional beliefs
        in adults, has proven in previous studies in adult clinical and non-clinical samples, to
        significantly decrease maladaptive beliefs associated with OCD and obsessive-compulsive
        symptomatology. Also, it can significantly increase self-esteem. Therefore, it is relevant to
        adapt the GGOC application to the adolescent population (GGOC-AD) and evaluate its
        effectiveness.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants that meet the inclusion criteria will complete the web-based baseline assessment (pre), with questionnaires relating to maladaptive beliefs, mood (anxiety and depressions), self-esteem and OCD symptoms. After, experimental group will use the GGOC-AD, and control group will use the GGN-AD for 14 days. Then, both groups will complete again the above-mentioned assessment instruments (post use of the app). Finally, all participants will complete the follow-up measures at one month.
  primary purpose: Prevention
  masking: Single (Participant)
  measure: Change in obsessive beliefs
  time frame: Through app completion (14 days) and 1 month follow-up
  description: Score change in obsessive compulsive maladaptive beliefs measured by the Obsessive Beliefs Questionnaire-Child Version (OBQ-CV). Total score is computed as a mean of the 44 items, ranging from 0 "strongly disagree" to 4 "strongly agree". Higher scores indicate the person has more obsessive beliefs.
  measure: Change in obsessive-compulsive symptomatology
  time frame: Through app completion (14 days) and 1 month follow-up
  description: Score change in obsessive-compulsive symptoms measured by the Obsessive Compulsive Inventory- Child Version (OCI-R-CV). Total score is computed as a mean of the 21 items, ranging from 0 "never" to 2 "always". Higher scores indicate a greater presence of obsessive-compulsive symptoms.
  measure: No change in emotional symptoms
  time frame: Through app completion (14 days) and 1 month follow-up
  description: No changes in depression and anxiety symptoms measured by The Patient Health Questionnaire for Depression and Anxiety (PH-4). It consists of 4 items, two for Anxiety and two for Depression, with a 4-point Likert scale (from 0 = "never" to 3 = "almost every day"). Higher scores indicate a greater presence of depression or anxiety symptoms.
  measure: Change in self-esteem
  time frame: Through app completion (14 days) and 1 month follow-up
  description: Change in score of Single Item Self Esteem Scale (SISE). Self-Esteem is measured with this single item ranging from 1 "It is not very true for me" to 7 "It is very true for me". Higher scores indicate a higher self-esteem.
  arm group label: GGOC-AD (GG Obsessive-Compulsive Disorder - Adolescents)
  arm group type: Experimental
  description: The experimental group will use the GGOC-AD module for 14 days after the first assessment.
  arm group label: GGN-AD (GG Neutral - Adolescents)
  arm group type: Active Comparator
  description: The control group will use the GGN-AD module for 14 days after the first assessment.
  intervention type: Device
  intervention name: GGOC-AD (GG Obsessive-Compulsive Disorder - Adolescents)
  description: GGOC was originally designed to challenge maladaptive beliefs that underline OCD symptoms in adult population. It was adapted to adolescent population. It consists of statements that are presented to the user, and that can portray either negative ("I can't trust myself") or positive beliefs ("I have a lot of good characteristics"). Users have to respond by either pulling these towards "Accept" or "Reject".
  arm group label: GGOC-AD (GG Obsessive-Compulsive Disorder - Adolescents)
  intervention type: Device
  intervention name: GGN-AD (GG Neutral - Adolescents)
  description: it was designed to have a comparison group. It consists of neutral statements such as "Madrid is a Spanish city", that ought not to produce changes in the direction of our hypothesis. These have to be "Accepted" or "Rejected" based on their veracity.
  arm group label: GGN-AD (GG Neutral - Adolescents)
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Gemma García-Soriano
  role: Principal Investigator
  affiliation: University of Valencia
  last name: Gemma García-Soriano
  phone: +34 963983389
  email: gemma.garcia@uv.es
  url: https://play.google.com/store/apps/details?id=air.com.samuramu.gg.oc
  description: Link to download the app from Google Play
  citation: Roncero M, Belloch A, Doron G. Can Brief, Daily Training Using a Mobile App Help Change Maladaptive Beliefs? Crossover Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Feb 13;7(2):e11443. doi: 10.2196/11443.
  PMID: 30758294
  responsible party type: Principal Investigator
  investigator affiliation: University of Valencia
  investigator full name: Gemma García-Soriano
  investigator title: PhD, associate professor
  mesh term: Compulsive Personality Disorder
  mesh term: Obsessive-Compulsive Disorder
  sharing ipd: Yes
  ipd description: Share all IPD that underlie results in a publication.
  ipd time frame: It will be available for 3 months after the publication of the study.
  ipd access criteria: Data will be available in the repository website of the University of Valencia.
  ipd url: http://roderic.uv.es/