<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/NCT03769350</url>
  </required_header>
  <id_info>
    <org_study_id>2018P001670-A</org_study_id>
    <nct_id>NCT03769350</nct_id>
  </id_info>
  <brief_title>Waitlist-Control Trial of Smartphone CBT for Major Depressive Disorder (MDD)</brief_title>
  <official_title>Smartphone Cognitive Behavioral Therapy for Major Depressive Disorder: A Randomized, Waitlist-control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Telefónica S.A.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral&#xD;
      therapy (CBT) treatment for major depressive disorder (MDD). The investigators hypothesize&#xD;
      that participants receiving app-CBT will have greater improvement in QIDS-C scores than those&#xD;
      in the waitlist condition at treatment endpoint (week 8).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aims of this study are to test the efficacy of a Smartphone-based CBT treatment&#xD;
      for adults with MDD recruited nationally. Eligible subjects (N=112) will be randomly assigned&#xD;
      to 8 weeks of Smartphone-delivered CBT for MDD either immediately, or after a 8-week long&#xD;
      waiting period (50-50 chance). The investigators hypothesize that Smartphone-delivered CBT&#xD;
      for MDD will be feasible and acceptable to individuals with MDD, and that it will lead to&#xD;
      greater reductions in MDD symptom severity compared to the passage of time (waitlist&#xD;
      control).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study must be registered under the sponsor instead of the site, so we have created a new&#xD;
    posting in the sponsor's account.&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 1, 2019</start_date>
  <completion_date type="Anticipated">June 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 1, 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>Difference in MDD severity (QIDS-C) at the end of treatment/waitlist period.</measure>
    <time_frame>Endpoint (week 8)</time_frame>
    <description>The Quick Inventory of Depressive Symptomatology- Clinician version (QIDS-C) is a clinician-administered interview that assesses depressive symptom severity in the past seven days. It contains 16 items ranging from 0-3, which are summed to generate a total score of depressive symptom severity (range=0-27).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in functional impairment at the end of treatment/waitlist period</measure>
    <time_frame>Endpoint (week 8)</time_frame>
    <description>Participants who receive app-CBT will have greater improvement on functional impairment (SDS). The SDS uses a Likert scale from 0 (not at all) to 10 (extremely) to assess impairment in occupational, social, and family domains. Higher scores indicate greater impairment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in quality of life at the end of treatment/waitlist period</measure>
    <time_frame>Endpoint (week 8)</time_frame>
    <description>Participants who receive app-CBT will have greater improvement on quality of life, assessed using The Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (Q-LES-Q). The Q-LES-Q-SF is a self-report measure of subjective quality of life, containing Likert items ranging from 1 (Very Poor) to 5 (Very Good). Total scores are presented as a percentage of the maximum value (i.e., ranging from 0 to 100, with higher scores indicating greater quality of life).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Smartphone-delivered CBT for MDD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8-week Smartphone delivered CBT for MDD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>8 Week Waitlist Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>8-week waitlist control. (Note: participants will be crossed over to 8-week Smartphone-delivered CBT for MDD following the 8-week waitlist control).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Smartphone-delivered CBT for MDD</intervention_name>
    <description>8-week Smartphone-delivered CBT for MDD. In-person cognitive-behavioral therapy (CBT) is an empirically supported treatment for MDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral activation, and perceptual retraining/mindfulness skills.</description>
    <arm_group_label>8 Week Waitlist Control</arm_group_label>
    <arm_group_label>Smartphone-delivered CBT for MDD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Current diagnosis of primary DSM-5 MDD, based on MINI&#xD;
&#xD;
          -  Currently living in the United States&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychotropic medication changes within 2 months prior to enrollment (Participants&#xD;
             taking psychotropic medication must have been on a stable dose for at least 2 months&#xD;
             prior to enrollment and not change medication during study period)&#xD;
&#xD;
          -  Past participation in ≥ 4 sessions of CBT for depression&#xD;
&#xD;
          -  Current severe substance use disorder&#xD;
&#xD;
          -  Lifetime bipolar disorder or psychosis&#xD;
&#xD;
          -  Acute, active suicidal ideation as indicated by clinical judgment and/or a score ≥ 2&#xD;
             on the suicidal ideation subscale of the C-SSRS&#xD;
&#xD;
          -  Concurrent psychological treatment&#xD;
&#xD;
          -  Does not own a supported mobile Smartphone with a data plan&#xD;
&#xD;
          -  Lack of technology literacy that would interfere with ability to engage with&#xD;
             smartphone treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sabine Wilhelm, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>August 4, 2022</last_update_submitted>
  <last_update_submitted_qc>August 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Sabine Wilhelm, PhD</investigator_full_name>
    <investigator_title>Chief of Psychology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</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/NCT03769350
org study id: 2018P001670-A
nct id: NCT03769350
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral
      therapy (CBT) treatment for major depressive disorder (MDD). The investigators hypothesize
      that participants receiving app-CBT will have greater improvement in QIDS-C scores than those
      in the waitlist condition at treatment endpoint (week 8).
The primary aims of this study are to test the efficacy of a Smartphone-based CBT treatment
      for adults with MDD recruited nationally. Eligible subjects (N=112) will be randomly assigned
      to 8 weeks of Smartphone-delivered CBT for MDD either immediately, or after a 8-week long
      waiting period (50-50 chance). The investigators hypothesize that Smartphone-delivered CBT
      for MDD will be feasible and acceptable to individuals with MDD, and that it will lead to
      greater reductions in MDD symptom severity compared to the passage of time (waitlist
      control).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Difference in MDD severity (QIDS-C) at the end of treatment/waitlist period.
time frame: Endpoint (week 8)
description: The Quick Inventory of Depressive Symptomatology- Clinician version (QIDS-C) is a clinician-administered interview that assesses depressive symptom severity in the past seven days. It contains 16 items ranging from 0-3, which are summed to generate a total score of depressive symptom severity (range=0-27).
measure: Difference in functional impairment at the end of treatment/waitlist period
time frame: Endpoint (week 8)
description: Participants who receive app-CBT will have greater improvement on functional impairment (SDS). The SDS uses a Likert scale from 0 (not at all) to 10 (extremely) to assess impairment in occupational, social, and family domains. Higher scores indicate greater impairment.
measure: Difference in quality of life at the end of treatment/waitlist period
time frame: Endpoint (week 8)
description: Participants who receive app-CBT will have greater improvement on quality of life, assessed using The Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (Q-LES-Q). The Q-LES-Q-SF is a self-report measure of subjective quality of life, containing Likert items ranging from 1 (Very Poor) to 5 (Very Good). Total scores are presented as a percentage of the maximum value (i.e., ranging from 0 to 100, with higher scores indicating greater quality of life).
arm group label: Smartphone-delivered CBT for MDD
arm group type: Experimental
description: 8-week Smartphone delivered CBT for MDD.
arm group label: 8 Week Waitlist Control
arm group type: Other
description: 8-week waitlist control. (Note: participants will be crossed over to 8-week Smartphone-delivered CBT for MDD following the 8-week waitlist control).
intervention type: Device
intervention name: Smartphone-delivered CBT for MDD
description: 8-week Smartphone-delivered CBT for MDD. In-person cognitive-behavioral therapy (CBT) is an empirically supported treatment for MDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral activation, and perceptual retraining/mindfulness skills.
arm group label: 8 Week Waitlist Control
arm group label: Smartphone-delivered CBT for MDD
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sabine Wilhelm, PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Sabine Wilhelm, PhD
investigator title: Chief of Psychology
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major