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/NCT06037382</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00032649</org_study_id>
      <nct_id>NCT06037382</nct_id>
    </id_info>
    <brief_title>Using a Smartphone App to Target Current Mental Health Symptoms of Anxiety and Depression</brief_title>
    <official_title>Using a Smartphone App to Target Current Mental Health Symptoms of Anxiety and Depression</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Trustees of Dartmouth College</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Norris Cotton Cancer Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Trustees of Dartmouth College</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>
        This is a prevention intervention study that will examine the efficacy of a smartphone-based&#xD;
        intervention in decreasing cancer risk by targeting mental health risk factors of anxiety and&#xD;
        depression.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 21, 2023</start_date>
    <completion_date type="Anticipated">May 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in depression as assessed by Patient Health Questionnaire-9</measure>
      <time_frame>Baseline</time_frame>
      <description>Possible PHQ-9 scores range from 0 to 27, with higher scores representing greater MDD symptom severity</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in depression as assessed by Patient Health Questionnaire-9</measure>
      <time_frame>6 weeks post-baseline</time_frame>
      <description>Possible PHQ-9 scores range from 0 to 27, with higher scores representing greater MDD symptom severity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in depression as assessed by Patient Health Questionnaire-9</measure>
      <time_frame>12 weeks post-baseline</time_frame>
      <description>Possible PHQ-9 scores range from 0 to 27, with higher scores representing greater MDD symptom severity</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale</measure>
      <time_frame>At baseline</time_frame>
      <description>Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale</measure>
      <time_frame>6 weeks post-baseline</time_frame>
      <description>Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale</measure>
      <time_frame>12 weeks post-baseline</time_frame>
      <description>Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity</description>
    </primary_outcome>
    <primary_outcome>
      <measure>World Cancer Research Fund (WCRF)/ American Institute for Cancer Research (AICR) Cancer Prevention Score.</measure>
      <time_frame>Up to 12 weeks after enrollment</time_frame>
      <description>Minimum score: 0, Maximum score: 7-8 (8 for persons capable of breastfeeding). Greater scores suggest lower cancer risk.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Smartphone estimates of sociability as mechanisms of change in cancer risk</measure>
      <time_frame>Up to 12 weeks after enrollment</time_frame>
      <description>Based on continuous passive mobile sensor data, sociability estimates will be based on the frequency of phone calls and texts.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Smartphone estimates of motion activity as mechanisms of change in cancer risk</measure>
      <time_frame>Up to 12 weeks after enrollment</time_frame>
      <description>Based on both activity levels based on the metabolic equivalent of task (MET) based on passively observed accelerometer data from the smartphone and daily movement based on geolocation data passively collected from the smartphone.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diet as mechanism of change in cancer risk</measure>
      <time_frame>Baseline, 6 weeks post-baseline, 12 weeks post-baseline</time_frame>
      <description>Self-reported dietary intake will be recorded via entry of food intake in ASA24 and used when calculating WCRF/AICR cancer score. Diets rich in nutrients contribute to higher score (lower risk).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Momentary Assessment of Anxiety Symptom Changes</measure>
      <time_frame>Up to 12 weeks after enrollment</time_frame>
      <description>Thirteen items from a modified PHQ/GAD questionnaire will be used to measure daily anxiety and depression. Participants will rate answers on a 101 point scale ranging from 0-100 and is scaled from &quot;Not at all&quot; - &quot;Constantly&quot;. Higher scores indicate generally more severe anxiety symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Momentary Assessment of Depression Symptom Changes</measure>
      <time_frame>Up to 12 weeks after enrollment</time_frame>
      <description>Thirteen items from a modified PHQ/GAD questionnaire will be used to measure daily anxiety and depression. Participants will rate answers on a 101 point scale ranging from 0-100 and is scaled from &quot;Not at all&quot; - &quot;Constantly&quot;. Higher scores indicate generally more severe MDD symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Momentary Assessment of Behavioral Avoidance Symptom Changes</measure>
      <time_frame>Up to 12 weeks after enrollment</time_frame>
      <description>One item adapted from the Multidimensional Experiential Avoidance Questionnaire will be presented to measure daily changes in behavioral avoidance. A second item will be asked to measure self-reported changes in behavioral avoidance since the previous prompt.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Momentary Assessment of Hopelessness Symptom Changes</measure>
      <time_frame>Up to 12 weeks after enrollment</time_frame>
      <description>One item adapted from the Hopelessness Scale will be presented to gather a momentary measurement. A second momentary measurement will be presented to gather current self-report of feeling hopelessness.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Momentary Assessment of Arousal Symptom Changes</measure>
      <time_frame>Up to 12 weeks after enrollment</time_frame>
      <description>A self-report measure will ask current level of arousal on a sliding scale from &quot;Sleepy&quot; to &quot;Active&quot;. Minimum or maximum values range from 0 (Sleepy) to 1 (Active).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Depression</condition>
    <condition>Anxiety</condition>
    <condition>Cancer</condition>
    <arm_group>
      <arm_group_label>MoodTriggers App</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Mood Triggers provides personalized feedback on individuals' maintenance factors (i.e., &quot;triggers&quot;) of their anxiety and depressive symptoms based on the theory that such feedback will lead to symptom reduction. Mood Triggers delivers ultra-brief interventions (less than 2 minutes long) where participants view videos which introduce an important skill to treat their anxiety and depressive.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Mood Triggers App</intervention_name>
      <description>The current intervention will deploy a smartphone application called Mood Triggers. Mood Triggers was designed to provide personalized feedback on individuals' maintenance factors (i.e., &quot;triggers&quot;) of their anxiety and depressive symptoms based on the theory that such feedback will lead to symptom reduction.</description>
      <arm_group_label>MoodTriggers App</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Middle-aged adults (age 40 to 64).&#xD;
  &#xD;
            2. fluent in English.&#xD;
  &#xD;
            3. Able to provide informed consent.&#xD;
  &#xD;
            4. Meets current criteria for an anxiety and/or depressive disorder with severity ranging&#xD;
               from moderate to severe (based on the Patient Health Questionnaire - 9 and the&#xD;
               Generalized Anxiety Disorder Questionnaire).&#xD;
  &#xD;
            5. Owns a smartphone.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Acute psychosis (based on the self-reported Structured Interview for Psychosis risk&#xD;
               Syndromes, Prodromal Questionnaire - Brief version [SIPS PQ-B]).&#xD;
  &#xD;
            2. Moderate to high suicidal ideation (based on a response of 2 or more on the PHQ-9&#xD;
               item-9).&#xD;
  &#xD;
            3. History of bipolar disorder (based on the self-reported Mood Disorder Questionnaire&#xD;
               [MDQ].&#xD;
  &#xD;
            4. Past or current diagnoses of cancer.&#xD;
  &#xD;
            5. Changes to treatments or medications in the past 30 days.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Eilis I Murphy, BA</last_name>
      <phone>6036467000</phone>
      <email>Eilis.I.Murphy@dartmouth.edu</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Trustees of Dartmouth College</investigator_affiliation>
      <investigator_full_name>Nicholas Jacobson</investigator_full_name>
      <investigator_title>Assistant Professor of Biomedical Data Science and Psychiatry</investigator_title>
    </responsible_party>
    <keyword>Cancer Prevention</keyword>
    <keyword>Passive sensing</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
      <mesh_term>Anxiety Disorders</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/NCT06037382
  org study id: STUDY00032649
  nct id: NCT06037382
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a prevention intervention study that will examine the efficacy of a smartphone-based
        intervention in decreasing cancer risk by targeting mental health risk factors of anxiety and
        depression.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Changes in depression as assessed by Patient Health Questionnaire-9
  time frame: Baseline
  description: Possible PHQ-9 scores range from 0 to 27, with higher scores representing greater MDD symptom severity
  measure: Changes in depression as assessed by Patient Health Questionnaire-9
  time frame: 6 weeks post-baseline
  description: Possible PHQ-9 scores range from 0 to 27, with higher scores representing greater MDD symptom severity.
  measure: Changes in depression as assessed by Patient Health Questionnaire-9
  time frame: 12 weeks post-baseline
  description: Possible PHQ-9 scores range from 0 to 27, with higher scores representing greater MDD symptom severity
  measure: Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale
  time frame: At baseline
  description: Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity
  measure: Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale
  time frame: 6 weeks post-baseline
  description: Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity
  measure: Change in anxiety symptoms as assessed by Generalized Anxiety Disorder- Q-IV Scale
  time frame: 12 weeks post-baseline
  description: Possible GAD-Q-IV scores range from 0 to 12, with higher scores representing greater GAD symptom severity
  measure: World Cancer Research Fund (WCRF)/ American Institute for Cancer Research (AICR) Cancer Prevention Score.
  time frame: Up to 12 weeks after enrollment
  description: Minimum score: 0, Maximum score: 7-8 (8 for persons capable of breastfeeding). Greater scores suggest lower cancer risk.
  measure: Smartphone estimates of sociability as mechanisms of change in cancer risk
  time frame: Up to 12 weeks after enrollment
  description: Based on continuous passive mobile sensor data, sociability estimates will be based on the frequency of phone calls and texts.
  measure: Smartphone estimates of motion activity as mechanisms of change in cancer risk
  time frame: Up to 12 weeks after enrollment
  description: Based on both activity levels based on the metabolic equivalent of task (MET) based on passively observed accelerometer data from the smartphone and daily movement based on geolocation data passively collected from the smartphone.
  measure: Diet as mechanism of change in cancer risk
  time frame: Baseline, 6 weeks post-baseline, 12 weeks post-baseline
  description: Self-reported dietary intake will be recorded via entry of food intake in ASA24 and used when calculating WCRF/AICR cancer score. Diets rich in nutrients contribute to higher score (lower risk).
  measure: Momentary Assessment of Anxiety Symptom Changes
  time frame: Up to 12 weeks after enrollment
  description: Thirteen items from a modified PHQ/GAD questionnaire will be used to measure daily anxiety and depression. Participants will rate answers on a 101 point scale ranging from 0-100 and is scaled from "Not at all" - "Constantly". Higher scores indicate generally more severe anxiety symptoms.
  measure: Momentary Assessment of Depression Symptom Changes
  time frame: Up to 12 weeks after enrollment
  description: Thirteen items from a modified PHQ/GAD questionnaire will be used to measure daily anxiety and depression. Participants will rate answers on a 101 point scale ranging from 0-100 and is scaled from "Not at all" - "Constantly". Higher scores indicate generally more severe MDD symptoms.
  measure: Momentary Assessment of Behavioral Avoidance Symptom Changes
  time frame: Up to 12 weeks after enrollment
  description: One item adapted from the Multidimensional Experiential Avoidance Questionnaire will be presented to measure daily changes in behavioral avoidance. A second item will be asked to measure self-reported changes in behavioral avoidance since the previous prompt.
  measure: Momentary Assessment of Hopelessness Symptom Changes
  time frame: Up to 12 weeks after enrollment
  description: One item adapted from the Hopelessness Scale will be presented to gather a momentary measurement. A second momentary measurement will be presented to gather current self-report of feeling hopelessness.
  measure: Momentary Assessment of Arousal Symptom Changes
  time frame: Up to 12 weeks after enrollment
  description: A self-report measure will ask current level of arousal on a sliding scale from "Sleepy" to "Active". Minimum or maximum values range from 0 (Sleepy) to 1 (Active).
  arm group label: MoodTriggers App
  arm group type: Experimental
  description: Mood Triggers provides personalized feedback on individuals' maintenance factors (i.e., "triggers") of their anxiety and depressive symptoms based on the theory that such feedback will lead to symptom reduction. Mood Triggers delivers ultra-brief interventions (less than 2 minutes long) where participants view videos which introduce an important skill to treat their anxiety and depressive.
  intervention type: Other
  intervention name: Mood Triggers App
  description: The current intervention will deploy a smartphone application called Mood Triggers. Mood Triggers was designed to provide personalized feedback on individuals' maintenance factors (i.e., "triggers") of their anxiety and depressive symptoms based on the theory that such feedback will lead to symptom reduction.
  arm group label: MoodTriggers App
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 64 Years
  healthy volunteers: No
  last name: Eilis I Murphy, BA
  phone: 6036467000
  email: Eilis.I.Murphy@dartmouth.edu
  responsible party type: Principal Investigator
  investigator affiliation: Trustees of Dartmouth College
  investigator full name: Nicholas Jacobson
  investigator title: Assistant Professor of Biomedical Data Science and Psychiatry
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Anxiety Disorders