<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/NCT03244878</url>
  </required_header>
  <id_info>
    <org_study_id>MS033017-FC</org_study_id>
    <nct_id>NCT03244878</nct_id>
  </id_info>
  <brief_title>Thrive, a Computerized Cognitive Behavior Therapy Program to Treat Depression</brief_title>
  <official_title>Randomized Controlled Trial of a Culturally-adapted Version of Thrive, a Computerized Cognitive Behavior Therapy (cCBT) Program to Treat Depressive Symptoms, Syndromes, and Disorders Among Rural Montanans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montana State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montana State University</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 study evaluates a culturally-modified version of Thrive, a computerized Cognitive&#xD;
      Behavior Therapy program to treat depressive symptoms, syndromes, and disorders among rural&#xD;
      Montanans. Study participants will be randomized to either a wait-list treatment as usual or&#xD;
      the Thrive program. After 8 weeks, the wait-list group will then receive Thrive. The primary&#xD;
      assessment measure is the Patient Health Questionnaire-9.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Montana ranks high among states on mental health disorder prevalence and low on access to&#xD;
      mental health care. It has the highest suicide rate in the nation. Of Montana's 56 counties,&#xD;
      10 are classified as rural and 45 as frontier, accentuating distance challenges in accessing&#xD;
      care. New treatment delivery modalities are needed to complement, supplement and augment&#xD;
      traditional mental health care. With increase in access to the Internet,&#xD;
      computer-administered Cognitive Behavior Therapy (cCBT) programs have emerged as viable&#xD;
      approaches to effective treatment of depression.&#xD;
&#xD;
      Thrive is an interactive cCBT program with a heavy emphasis on video rather than text content&#xD;
      that appears to improve participant engagement, a shortcoming seen in prior cCBT programs.&#xD;
&#xD;
      The goal of this project is to conduct a randomized wait-list controlled of Thrive to&#xD;
      determine its effectiveness in reducing depressive symptom severity among Montanans, many of&#xD;
      whom have few or no other options for mental health treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">January 31, 2018</completion_date>
  <primary_completion_date type="Actual">January 31, 2018</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 are randomized to either the wait-list controlled group or intervention group. Intervention period is 8 weeks. Data collection occurs at baseline, 4 weeks, and 8 weeks, with longer-term follow-up assessments.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Health Questionnaire-9</measure>
    <time_frame>2 weeks</time_frame>
    <description>Clinical measure of depressive symptom severity. Self-reported with a score range from 0 to 3 (not at all to nearly every day)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Generalized Anxiety Disorder-7</measure>
    <time_frame>2 weeks</time_frame>
    <description>Self-reported measure of anxiety symptoms with a scale from 0 to 3 (not at all to nearly every day)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Work and Social Adjustment Scale</measure>
    <time_frame>1 year</time_frame>
    <description>Self-reported measure of a chronic condition's impact on daily work and social life with a scale of 0 to 8 (none to very severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Connor-Davidson Resilience Scale</measure>
    <time_frame>1 month</time_frame>
    <description>Self-reported assessment of personal resilience with a scale of 0 to 3 (not true at all to often true)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">464</enrollment>
  <condition>Depressive Symptoms</condition>
  <arm_group>
    <arm_group_label>Intervention - Thrive program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive access to the Thrive program for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will have no access to the Thrive program for 8 weeks upon enrollment. They will receive a link to the NIMH website to read about information on depression.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Thrive</intervention_name>
    <description>A interactive computerized program using structured content of cognitive behavior therapy</description>
    <arm_group_label>Intervention - Thrive program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 years or older&#xD;
&#xD;
          -  Baseline PHQ-9 score of 5 or greater&#xD;
&#xD;
          -  Montana resident&#xD;
&#xD;
          -  Regular access to broadband internet (streaming capability)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No broadband internet access&#xD;
&#xD;
          -  Aged 17 years or younger&#xD;
&#xD;
          -  Does not have Montana residency&#xD;
&#xD;
          -  Baseline PHQ-9 score of &lt; 5&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Montana State University</name>
      <address>
        <city>Bozeman</city>
        <state>Montana</state>
        <zip>59717</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2017</study_first_posted>
  <last_update_submitted>August 12, 2018</last_update_submitted>
  <last_update_submitted_qc>August 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Montana State University</investigator_affiliation>
    <investigator_full_name>Mark B. Schure, Ph.D.</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Cognitive Behavior Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/78/NCT03244878/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03244878
org study id: MS033017-FC
nct id: NCT03244878
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates a culturally-modified version of Thrive, a computerized Cognitive
      Behavior Therapy program to treat depressive symptoms, syndromes, and disorders among rural
      Montanans. Study participants will be randomized to either a wait-list treatment as usual or
      the Thrive program. After 8 weeks, the wait-list group will then receive Thrive. The primary
      assessment measure is the Patient Health Questionnaire-9.
Montana ranks high among states on mental health disorder prevalence and low on access to
      mental health care. It has the highest suicide rate in the nation. Of Montana's 56 counties,
      10 are classified as rural and 45 as frontier, accentuating distance challenges in accessing
      care. New treatment delivery modalities are needed to complement, supplement and augment
      traditional mental health care. With increase in access to the Internet,
      computer-administered Cognitive Behavior Therapy (cCBT) programs have emerged as viable
      approaches to effective treatment of depression.

      Thrive is an interactive cCBT program with a heavy emphasis on video rather than text content
      that appears to improve participant engagement, a shortcoming seen in prior cCBT programs.

      The goal of this project is to conduct a randomized wait-list controlled of Thrive to
      determine its effectiveness in reducing depressive symptom severity among Montanans, many of
      whom have few or no other options for mental health treatment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are randomized to either the wait-list controlled group or intervention group. Intervention period is 8 weeks. Data collection occurs at baseline, 4 weeks, and 8 weeks, with longer-term follow-up assessments.
primary purpose: Treatment
masking: None (Open Label)
measure: Patient Health Questionnaire-9
time frame: 2 weeks
description: Clinical measure of depressive symptom severity. Self-reported with a score range from 0 to 3 (not at all to nearly every day)
measure: Generalized Anxiety Disorder-7
time frame: 2 weeks
description: Self-reported measure of anxiety symptoms with a scale from 0 to 3 (not at all to nearly every day)
measure: Work and Social Adjustment Scale
time frame: 1 year
description: Self-reported measure of a chronic condition's impact on daily work and social life with a scale of 0 to 8 (none to very severe)
measure: Connor-Davidson Resilience Scale
time frame: 1 month
description: Self-reported assessment of personal resilience with a scale of 0 to 3 (not true at all to often true)
arm group label: Intervention - Thrive program
arm group type: Experimental
description: Participants will receive access to the Thrive program for 8 weeks
arm group label: Wait-list Control
arm group type: No Intervention
description: Participants will have no access to the Thrive program for 8 weeks upon enrollment. They will receive a link to the NIMH website to read about information on depression.
intervention type: Behavioral
intervention name: Thrive
description: A interactive computerized program using structured content of cognitive behavior therapy
arm group label: Intervention - Thrive program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Montana State University
investigator full name: Mark B. Schure, Ph.D.
investigator title: Assistant Professor
mesh term: Depression
sharing ipd: No
provided document: 