<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/NCT04507360</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00010958</org_study_id>
    <nct_id>NCT04507360</nct_id>
  </id_info>
  <brief_title>Enhancing Engagement With Digital Mental Health Care</brief_title>
  <official_title>Enhancing Engagement With Digital Mental Health Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Washington</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mental Health America</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Talkspace</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Washington</source>
  <oversight_info>
    <has_dmc>Yes</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 proposal is a partnership between Mental Health America (MHA), a nonprofit mental health&#xD;
      advocacy and resource organization, Talkspace (TS), a for-profit, online digital&#xD;
      psychotherapy organization, and the University of Washington's Schools of Medicine and&#xD;
      Computer Science Engineering (UW). The purpose of this partnership is to create a digital&#xD;
      mental health research platform leveraging MHA and TS's marketing platforms and consumer base&#xD;
      to describe the characteristics of optimal engagement with digital mental health treatment,&#xD;
      and to identify effective, personalized methods to enhance motivation to engage in digital&#xD;
      mental health treatment in order to improve mental health outcomes. These aims will be met by&#xD;
      identifying and following at least 100,000 MHA and TS consumers over the next 4 years, apply&#xD;
      machine learning approaches to characterizing client engagement subtypes, and apply&#xD;
      micro-randomized trials to study the effectiveness of motivational enhancement strategies and&#xD;
      response to digital mental health treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Digital mental health (DMH) is the use of technology to improve population well-being through&#xD;
      rapid disease detection, outcome measurement, and care. Although several randomized clinical&#xD;
      trials have demonstrated that digital mental health tools are highly effective, most&#xD;
      consumers do not sustain their use of these tools. The field currently lacks an understanding&#xD;
      of DMH tool engagement, how engagement is associated with well-being, and what practices are&#xD;
      effective at sustaining engagement. In this partnership between Mental Health America (MHA),&#xD;
      Talkspace (TS) and the University of Washington (UW), the investigators propose a&#xD;
      naturalistic and experimental, theory-driven program of research, with the aim of&#xD;
      understanding 1) how consumer engagement in self-help and clinician assisted DMH varies and&#xD;
      what engagement patterns exist, 2) the association between patterns of engagement and&#xD;
      important consumer outcomes, and 3) the effectiveness of personalized strategies for optimal&#xD;
      engagement with DMH treatment.&#xD;
&#xD;
      This study will prospectively follow a large, naturalistic sample of MHA and TS consumers,&#xD;
      and will apply machine learning, user-centered design strategies, and micro randomized and&#xD;
      sequential multiple assignment randomized (SMART) trials to address these aims. As is usual&#xD;
      practice for both platforms, consumers will complete online mental health screening and&#xD;
      assessment, and the investigators will be able to classify participants by disease status and&#xD;
      symptom severity. The sample that the investigators will be working with will not be limited&#xD;
      by diagnosis or co-morbidities. Participants will be 10 years old and older and enter the MHA&#xD;
      and TS platforms prospectively over 4 years. In order to test the first aim, the&#xD;
      investigators will identify a minimum of 100,000 consumers who have accessed MHA and TS&#xD;
      platforms in the past. Participant data will be analyzed statistically to reveal differences&#xD;
      in engagement and dropout across groups based on demographics, symptoms and platform&#xD;
      activity. For aim 2, the investigators will use supervised machine learning techniques to&#xD;
      identify subtypes based on consumer demographics, engagement patterns with DMH, reasons for&#xD;
      disengagement, success of existing MHA and TS engagement strategies, and satisfaction with&#xD;
      the DMH tools, that are predictive of future engagement patterns. Finally, based on the&#xD;
      outcomes from aim 2, in aim 3 the investigators will conduct focus groups applying user&#xD;
      centered design strategies to identify and co-build potentially effective engagement&#xD;
      strategies for particular client subtypes. The investigators will then conduct a series of&#xD;
      micro-randomized and SMART trials to determine which theory-driven engagement strategies,&#xD;
      co-designed with users, have the greatest fit with subtypes developed under aim 2. The&#xD;
      investigators will test the effectiveness of these strategies to 1) prevent disengagement&#xD;
      from those who are more likely to have poor outcomes after disengagement, 2) improve movement&#xD;
      from motivation to volition and, 3) enhance optimal dose of DMH engagement and consequently&#xD;
      improve mental health outcomes. These data will be analyzed using longitudinal mixed effects&#xD;
      models with effect coding to estimate the effectiveness of each strategy on client engagement&#xD;
      behavior and mental health outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 15, 2021</start_date>
  <completion_date type="Anticipated">November 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">August 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>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Micro-Randomized (MRT) and Sequential Multiple Assignment Randomized (SMART) Trials offer methodological tools that can harness the sheer volume of DMH clients and interactions in order to optimize and test personalize engagement strategies. For aim 3, the investigators will conduct focus groups applying user-centered design strategies to identify and co-build potentially effective engagement strategies for particular client subtypes. The investigators will then conduct a series of micro-randomized and sequential multiple assignment randomized (SMART) trials to determine which theory-driven engagement strategies, co-designed with users, have the greatest fit with subtypes developed under aim 2. The investigators anticipate enrolling 10,000 Talkspace consumers in the SMART trial, with a subset of 250 participating in a survey after they discontinue treatment. The number of arms will be based on learnings re: engagement strategies from previous phases.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mental Health America Engagement</measure>
    <time_frame>2 months</time_frame>
    <description>Increased time spent on webpages</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mental Health America Engagement</measure>
    <time_frame>2 months</time_frame>
    <description>Number of article(s) read on topics indicative of ambivalence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mental Health America Engagement</measure>
    <time_frame>2 months</time_frame>
    <description>Number of mental health screens taken</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mental Health America Engagement</measure>
    <time_frame>2 months</time_frame>
    <description>Clicks to outside service provider page (including Talkspace)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mental Health America Engagement</measure>
    <time_frame>2 months</time_frame>
    <description>Use of outside services (e.g. therapeutic video games, communities, and online therapy services including Talkspace)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mental Health America Engagement</measure>
    <time_frame>2 months</time_frame>
    <description>Return to MHA website after screening and reading materials</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mental Health America Engagement</measure>
    <time_frame>2 months</time_frame>
    <description>Length of time until next MHA website visit</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mental Health America Engagement</measure>
    <time_frame>2 months</time_frame>
    <description>Length of time until website visits end for two months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Talkspace Engagement</measure>
    <time_frame>2 months</time_frame>
    <description>Increased time on website</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Talkspace Engagement</measure>
    <time_frame>2 months</time_frame>
    <description>Visit to app install page</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Talkspace Engagement</measure>
    <time_frame>2 months</time_frame>
    <description>Download app</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Talkspace Engagement</measure>
    <time_frame>2 months</time_frame>
    <description>Enrollment and completion of intake assessment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Talkspace Engagement</measure>
    <time_frame>2 months</time_frame>
    <description>Texts sent to therapist - occurrence</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Talkspace Engagement</measure>
    <time_frame>2 months</time_frame>
    <description>Texts sent to therapist - number of texts</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Talkspace Engagement</measure>
    <time_frame>2 months</time_frame>
    <description>Texts sent to therapist - length of texts</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Talkspace Engagement</measure>
    <time_frame>2 months</time_frame>
    <description>Texts sent to therapist - frequency</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Talkspace Engagement</measure>
    <time_frame>Every 3 weeks for 2 months</time_frame>
    <description>Completion of outcome measures</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Talkspace Engagement</measure>
    <time_frame>2 months</time_frame>
    <description>Length of time until communication with providers ends</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>Baseline</time_frame>
    <description>The PHQ-9 consists of 9 depression items and one disability item. Each time is associated with a DMS symptom of depression, which the participant rates whether or not they have experienced the symptom over the last two weeks, with severity rating of 0-3. It is one of the few measures that is brief (it takes less than one minute to give) and has been found to have excellent sensitivity to change over time. Used for screening and will be used as a moderator.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Generalized Anxiety Disorder (GAD-7)</measure>
    <time_frame>Baseline</time_frame>
    <description>A 7- item screener for generalized anxiety. It consists of items related to GAD. Participants rate on a scale of 0-3 how much they have experienced in the last two weeks. The scale is a valid screener for GAD.Used for screening and will be used as a moderator.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neuro-QoL Short Form - Ability to Participate in Social Roles and Activities</measure>
    <time_frame>Baseline</time_frame>
    <description>A measure of disability/functional status that assesses the ability to participate in social roles and activities across neurological conditions visual-spatial, numeric and verbal anchors. The scale has been validated in medical and psychiatric populations with a variety of psychiatric diagnoses. Used for screening and will be used as a moderator.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Working Alliance Inventory, Short Form</measure>
    <time_frame>From start of treatment, every 3 weeks until and at treatment completion (up to 9 weeks for majority of Talkspace consumers)</time_frame>
    <description>The WAI is a 12-item measure of therapeutic alliance (relationship between the consumer and therapist or coach). It is a reliable measure of alliance, with alpha = .92.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Task Self-Efficacy</measure>
    <time_frame>Baseline</time_frame>
    <description>Single item based on McAuley and Mihalko's guidelines for measuring task self-efficacy.&#xD;
Consumers rate how confident they are in their ability to engage in DMH services if they were motivated enough to do so.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Needs/Risks</measure>
    <time_frame>Baseline</time_frame>
    <description>Single item that consumers will be asked to rate about the chance of their symptoms becoming worse if they do not act, on a 4-point scale from not high to very high.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Outcome expectancies</measure>
    <time_frame>Baseline</time_frame>
    <description>Three items: &quot;What do you think will be the consequences for yourself if you begin DMH treatment?&quot; Consumers will rank these choice options (a) &quot;I will be healthier,&quot; (b) &quot;I will feel better mentally,&quot; (c) &quot;It will improve my quality of life&quot; (1=not true; 4=exactly true).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral Intention</measure>
    <time_frame>Baseline</time_frame>
    <description>Two items commonly used in the behavioral medicine and recommended by Azjen et al.&#xD;
Consumers will be asked to rate how true the statement: &quot;I will try to review information about mental health services over the next week&quot; is for them (1 = definitely false; 4 = definitely true); and to what extent is the statement: &quot;I intend to send some time learning about my treatment options over the next week&quot; likely for them (1 = not likely; 4 = extremely likely).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Action Planning</measure>
    <time_frame>Baseline</time_frame>
    <description>Existing questions about goals for visiting MHA and TS websites, with one item that asks consumers will rate (1 = not true; 4 = extremely true) whether they had made detailed plans regarding their mental health goals: (a) where; (b) when; (c) what types of activities they will do; (d) how often; and (e) how long they will engage in DMH.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maintenance Self-efficacy</measure>
    <time_frame>Week 1</time_frame>
    <description>This question asks consumers to rate their confidence in their ability to text their therapist over the next week even if they had to overcome these barriers: no immediate positive effects, technical problems, perceived difficulties, and lack of motivation. All items will be rated on a seven-point scale (1 = not confident at all; 4 = completely confident).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reasons for disengagement</measure>
    <time_frame>Disengagement (up to 9 weeks from treatment engagement for majority of Talkspace consumers)</time_frame>
    <description>Four items to determine if the service just used met their needs</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Satisfaction with Talkspace</measure>
    <time_frame>Treatment completion (up to 9 weeks from treatment engagement for majority of Talkspace consumers)</time_frame>
    <description>Satisfaction with Talkspace clinical services, measure created by TS and asks whether goals were met</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction with outside services</measure>
    <time_frame>Treatment completion (an average of 2-4 weeks from treatment engagement)</time_frame>
    <description>Satisfaction with outside services (administered to MHA consumers)</description>
  </other_outcome>
  <other_outcome>
    <measure>Prodromal Questionnaire - Brief Version</measure>
    <time_frame>Baseline</time_frame>
    <description>A validated measure of symptoms indicating risk for psychosis. 21 dichotomous response items. Used for screening and will be used as a moderator.</description>
  </other_outcome>
  <other_outcome>
    <measure>Brief Bipolar Test</measure>
    <time_frame>Baseline</time_frame>
    <description>A brief, validated self-report instrument designed to indicate bipolar symptoms. Used for screening and will be used as a moderator.</description>
  </other_outcome>
  <other_outcome>
    <measure>Stanford-Washington University Eating Disorder (SWED) Screen</measure>
    <time_frame>Baseline</time_frame>
    <description>A brief, 11-item validated self-report instrument designed to indicate eating disorders. Used for screening and will be used as a moderator.</description>
  </other_outcome>
  <other_outcome>
    <measure>Primary Care - Post Traumatic Stress Disorder Screen (PC-PTSD)</measure>
    <time_frame>Baseline</time_frame>
    <description>A brief, 4 item screen for PTSD for the primary care population. Used for screening and will be used as a moderator.</description>
  </other_outcome>
  <other_outcome>
    <measure>CAGE-AID</measure>
    <time_frame>Baseline</time_frame>
    <description>A brief, 4-item screen for alcohol addiction. Used for screening and will be used as a moderator.</description>
  </other_outcome>
  <other_outcome>
    <measure>Healthy Workplace Survey</measure>
    <time_frame>Baseline</time_frame>
    <description>A brief measure created by MHA to examine workplace mental health, examining the psychological safety, fairness, and healthiness of work environment. Will be used as a moderator.</description>
  </other_outcome>
  <other_outcome>
    <measure>Duke Social Support Scale</measure>
    <time_frame>Baseline</time_frame>
    <description>A validated, brief, 11 item self-report measure of the amount of social support a person feels. Will be used as a moderator.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Engagement, Patient</condition>
  <arm_group>
    <arm_group_label>Engagement Strategy - 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Engagement strategies that will be tested in Aim 3 in Y04 will be developed based on learnings from Aims 1 and 2 in Y01-Y03 of the project.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Engagement Strategy - 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Engagement strategies that will be tested in Aim 3 in Y04 will be developed based on learnings from Aims 1 and 2 in Y01-Y03 of the project.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Engagement Strategies TBD</intervention_name>
    <description>Engagement strategies that will be tested in Aim 3 in Y04 will be developed based on learnings from Aims 1 and 2 in Y01-Y03 of the project.</description>
    <arm_group_label>Engagement Strategy - 1</arm_group_label>
    <arm_group_label>Engagement Strategy - 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Phase 1 (100K) and Phase 2 (50K): MHA and TS consumers who are naturalistically&#xD;
             seeking services; Aged 14 and older; English or Spanish speaking&#xD;
&#xD;
          -  Focus Groups: Adult MHA and TS consumers, English speaking or bilingual English &amp;&#xD;
             Spanish speakers&#xD;
&#xD;
          -  Phase 3a (10,000): TS consumers, 18 years old and older, English or Spanish speaking&#xD;
&#xD;
          -  Phase 3b (250): TS consumers, 18 years old and older, PHQ-9 or GAD-7 of 10 or greater,&#xD;
             English or Spanish speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Phase 1 (100K) and Phase 2 (50K): Younger than 14 years old; Non-English or&#xD;
             Non-Spanish speaking&#xD;
&#xD;
          -  Focus Groups: Younger than 18 years old; Non-English speaking or Non-bilingual&#xD;
             (English &amp; Spanish)&#xD;
&#xD;
          -  Phase 3a (10,000): Younger than 18 years old, Non-English or Non-Spanish speaking&#xD;
&#xD;
          -  Phase 3b (250): Younger than 18 years old, Non-English or Non-Spanish speaking, PHQ-9&#xD;
             or GAD-7 of less than 10&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patricia A Arean, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Washington</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Brittany Mosser, MSW</last_name>
    <phone>206-616-2129</phone>
    <email>bmosser@uw.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Groop Internet Platform DBA Talkspace</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10023</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Derrick Hull, PhD</last_name>
      <phone>480-254-8815</phone>
      <email>derrick@talkspace.com</email>
    </contact>
    <investigator>
      <last_name>Derrick Hull, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mental Health America</name>
      <address>
        <city>Alexandria</city>
        <state>Virginia</state>
        <zip>22314</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Theresa Nguyen, LCSW</last_name>
      <phone>703-838-7536</phone>
      <email>tnguyen@mhanational.org</email>
    </contact>
    <investigator>
      <last_name>Theresa Nguyen, MSW</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>March 29, 2022</last_update_submitted>
  <last_update_submitted_qc>March 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Washington</investigator_affiliation>
    <investigator_full_name>Pat Arean</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Digital Mental Health</keyword>
  <!-- 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/NCT04507360
org study id: STUDY00010958
nct id: NCT04507360
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This proposal is a partnership between Mental Health America (MHA), a nonprofit mental health
      advocacy and resource organization, Talkspace (TS), a for-profit, online digital
      psychotherapy organization, and the University of Washington's Schools of Medicine and
      Computer Science Engineering (UW). The purpose of this partnership is to create a digital
      mental health research platform leveraging MHA and TS's marketing platforms and consumer base
      to describe the characteristics of optimal engagement with digital mental health treatment,
      and to identify effective, personalized methods to enhance motivation to engage in digital
      mental health treatment in order to improve mental health outcomes. These aims will be met by
      identifying and following at least 100,000 MHA and TS consumers over the next 4 years, apply
      machine learning approaches to characterizing client engagement subtypes, and apply
      micro-randomized trials to study the effectiveness of motivational enhancement strategies and
      response to digital mental health treatment.
Digital mental health (DMH) is the use of technology to improve population well-being through
      rapid disease detection, outcome measurement, and care. Although several randomized clinical
      trials have demonstrated that digital mental health tools are highly effective, most
      consumers do not sustain their use of these tools. The field currently lacks an understanding
      of DMH tool engagement, how engagement is associated with well-being, and what practices are
      effective at sustaining engagement. In this partnership between Mental Health America (MHA),
      Talkspace (TS) and the University of Washington (UW), the investigators propose a
      naturalistic and experimental, theory-driven program of research, with the aim of
      understanding 1) how consumer engagement in self-help and clinician assisted DMH varies and
      what engagement patterns exist, 2) the association between patterns of engagement and
      important consumer outcomes, and 3) the effectiveness of personalized strategies for optimal
      engagement with DMH treatment.

      This study will prospectively follow a large, naturalistic sample of MHA and TS consumers,
      and will apply machine learning, user-centered design strategies, and micro randomized and
      sequential multiple assignment randomized (SMART) trials to address these aims. As is usual
      practice for both platforms, consumers will complete online mental health screening and
      assessment, and the investigators will be able to classify participants by disease status and
      symptom severity. The sample that the investigators will be working with will not be limited
      by diagnosis or co-morbidities. Participants will be 10 years old and older and enter the MHA
      and TS platforms prospectively over 4 years. In order to test the first aim, the
      investigators will identify a minimum of 100,000 consumers who have accessed MHA and TS
      platforms in the past. Participant data will be analyzed statistically to reveal differences
      in engagement and dropout across groups based on demographics, symptoms and platform
      activity. For aim 2, the investigators will use supervised machine learning techniques to
      identify subtypes based on consumer demographics, engagement patterns with DMH, reasons for
      disengagement, success of existing MHA and TS engagement strategies, and satisfaction with
      the DMH tools, that are predictive of future engagement patterns. Finally, based on the
      outcomes from aim 2, in aim 3 the investigators will conduct focus groups applying user
      centered design strategies to identify and co-build potentially effective engagement
      strategies for particular client subtypes. The investigators will then conduct a series of
      micro-randomized and SMART trials to determine which theory-driven engagement strategies,
      co-designed with users, have the greatest fit with subtypes developed under aim 2. The
      investigators will test the effectiveness of these strategies to 1) prevent disengagement
      from those who are more likely to have poor outcomes after disengagement, 2) improve movement
      from motivation to volition and, 3) enhance optimal dose of DMH engagement and consequently
      improve mental health outcomes. These data will be analyzed using longitudinal mixed effects
      models with effect coding to estimate the effectiveness of each strategy on client engagement
      behavior and mental health outcomes.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Micro-Randomized (MRT) and Sequential Multiple Assignment Randomized (SMART) Trials offer methodological tools that can harness the sheer volume of DMH clients and interactions in order to optimize and test personalize engagement strategies. For aim 3, the investigators will conduct focus groups applying user-centered design strategies to identify and co-build potentially effective engagement strategies for particular client subtypes. The investigators will then conduct a series of micro-randomized and sequential multiple assignment randomized (SMART) trials to determine which theory-driven engagement strategies, co-designed with users, have the greatest fit with subtypes developed under aim 2. The investigators anticipate enrolling 10,000 Talkspace consumers in the SMART trial, with a subset of 250 participating in a survey after they discontinue treatment. The number of arms will be based on learnings re: engagement strategies from previous phases.
primary purpose: Health Services Research
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Mental Health America Engagement
time frame: 2 months
description: Increased time spent on webpages
measure: Mental Health America Engagement
time frame: 2 months
description: Number of article(s) read on topics indicative of ambivalence
measure: Mental Health America Engagement
time frame: 2 months
description: Number of mental health screens taken
measure: Mental Health America Engagement
time frame: 2 months
description: Clicks to outside service provider page (including Talkspace)
measure: Mental Health America Engagement
time frame: 2 months
description: Use of outside services (e.g. therapeutic video games, communities, and online therapy services including Talkspace)
measure: Mental Health America Engagement
time frame: 2 months
description: Return to MHA website after screening and reading materials
measure: Mental Health America Engagement
time frame: 2 months
description: Length of time until next MHA website visit
measure: Mental Health America Engagement
time frame: 2 months
description: Length of time until website visits end for two months
measure: Talkspace Engagement
time frame: 2 months
description: Increased time on website
measure: Talkspace Engagement
time frame: 2 months
description: Visit to app install page
measure: Talkspace Engagement
time frame: 2 months
description: Download app
measure: Talkspace Engagement
time frame: 2 months
description: Enrollment and completion of intake assessment
measure: Talkspace Engagement
time frame: 2 months
description: Texts sent to therapist - occurrence
measure: Talkspace Engagement
time frame: 2 months
description: Texts sent to therapist - number of texts
measure: Talkspace Engagement
time frame: 2 months
description: Texts sent to therapist - length of texts
measure: Talkspace Engagement
time frame: 2 months
description: Texts sent to therapist - frequency
measure: Talkspace Engagement
time frame: Every 3 weeks for 2 months
description: Completion of outcome measures
measure: Talkspace Engagement
time frame: 2 months
description: Length of time until communication with providers ends
measure: Patient Health Questionnaire (PHQ-9)
time frame: Baseline
description: The PHQ-9 consists of 9 depression items and one disability item. Each time is associated with a DMS symptom of depression, which the participant rates whether or not they have experienced the symptom over the last two weeks, with severity rating of 0-3. It is one of the few measures that is brief (it takes less than one minute to give) and has been found to have excellent sensitivity to change over time. Used for screening and will be used as a moderator.
measure: Generalized Anxiety Disorder (GAD-7)
time frame: Baseline
description: A 7- item screener for generalized anxiety. It consists of items related to GAD. Participants rate on a scale of 0-3 how much they have experienced in the last two weeks. The scale is a valid screener for GAD.Used for screening and will be used as a moderator.
measure: Neuro-QoL Short Form - Ability to Participate in Social Roles and Activities
time frame: Baseline
description: A measure of disability/functional status that assesses the ability to participate in social roles and activities across neurological conditions visual-spatial, numeric and verbal anchors. The scale has been validated in medical and psychiatric populations with a variety of psychiatric diagnoses. Used for screening and will be used as a moderator.
measure: Working Alliance Inventory, Short Form
time frame: From start of treatment, every 3 weeks until and at treatment completion (up to 9 weeks for majority of Talkspace consumers)
description: The WAI is a 12-item measure of therapeutic alliance (relationship between the consumer and therapist or coach). It is a reliable measure of alliance, with alpha = .92.
measure: Task Self-Efficacy
time frame: Baseline
description: Single item based on McAuley and Mihalko's guidelines for measuring task self-efficacy.
Consumers rate how confident they are in their ability to engage in DMH services if they were motivated enough to do so.
measure: Perceived Needs/Risks
time frame: Baseline
description: Single item that consumers will be asked to rate about the chance of their symptoms becoming worse if they do not act, on a 4-point scale from not high to very high.
measure: Outcome expectancies
time frame: Baseline
description: Three items: "What do you think will be the consequences for yourself if you begin DMH treatment?" Consumers will rank these choice options (a) "I will be healthier," (b) "I will feel better mentally," (c) "It will improve my quality of life" (1=not true; 4=exactly true).
measure: Behavioral Intention
time frame: Baseline
description: Two items commonly used in the behavioral medicine and recommended by Azjen et al.
Consumers will be asked to rate how true the statement: "I will try to review information about mental health services over the next week" is for them (1 = definitely false; 4 = definitely true); and to what extent is the statement: "I intend to send some time learning about my treatment options over the next week" likely for them (1 = not likely; 4 = extremely likely).
measure: Action Planning
time frame: Baseline
description: Existing questions about goals for visiting MHA and TS websites, with one item that asks consumers will rate (1 = not true; 4 = extremely true) whether they had made detailed plans regarding their mental health goals: (a) where; (b) when; (c) what types of activities they will do; (d) how often; and (e) how long they will engage in DMH.
measure: Maintenance Self-efficacy
time frame: Week 1
description: This question asks consumers to rate their confidence in their ability to text their therapist over the next week even if they had to overcome these barriers: no immediate positive effects, technical problems, perceived difficulties, and lack of motivation. All items will be rated on a seven-point scale (1 = not confident at all; 4 = completely confident).
measure: Reasons for disengagement
time frame: Disengagement (up to 9 weeks from treatment engagement for majority of Talkspace consumers)
description: Four items to determine if the service just used met their needs
measure: Satisfaction with Talkspace
time frame: Treatment completion (up to 9 weeks from treatment engagement for majority of Talkspace consumers)
description: Satisfaction with Talkspace clinical services, measure created by TS and asks whether goals were met
measure: Satisfaction with outside services
time frame: Treatment completion (an average of 2-4 weeks from treatment engagement)
description: Satisfaction with outside services (administered to MHA consumers)
measure: Prodromal Questionnaire - Brief Version
time frame: Baseline
description: A validated measure of symptoms indicating risk for psychosis. 21 dichotomous response items. Used for screening and will be used as a moderator.
measure: Brief Bipolar Test
time frame: Baseline
description: A brief, validated self-report instrument designed to indicate bipolar symptoms. Used for screening and will be used as a moderator.
measure: Stanford-Washington University Eating Disorder (SWED) Screen
time frame: Baseline
description: A brief, 11-item validated self-report instrument designed to indicate eating disorders. Used for screening and will be used as a moderator.
measure: Primary Care - Post Traumatic Stress Disorder Screen (PC-PTSD)
time frame: Baseline
description: A brief, 4 item screen for PTSD for the primary care population. Used for screening and will be used as a moderator.
measure: CAGE-AID
time frame: Baseline
description: A brief, 4-item screen for alcohol addiction. Used for screening and will be used as a moderator.
measure: Healthy Workplace Survey
time frame: Baseline
description: A brief measure created by MHA to examine workplace mental health, examining the psychological safety, fairness, and healthiness of work environment. Will be used as a moderator.
measure: Duke Social Support Scale
time frame: Baseline
description: A validated, brief, 11 item self-report measure of the amount of social support a person feels. Will be used as a moderator.
arm group label: Engagement Strategy - 1
arm group type: Experimental
description: Engagement strategies that will be tested in Aim 3 in Y04 will be developed based on learnings from Aims 1 and 2 in Y01-Y03 of the project.
arm group label: Engagement Strategy - 2
arm group type: Experimental
description: Engagement strategies that will be tested in Aim 3 in Y04 will be developed based on learnings from Aims 1 and 2 in Y01-Y03 of the project.
intervention type: Behavioral
intervention name: Engagement Strategies TBD
description: Engagement strategies that will be tested in Aim 3 in Y04 will be developed based on learnings from Aims 1 and 2 in Y01-Y03 of the project.
arm group label: Engagement Strategy - 1
arm group label: Engagement Strategy - 2
criteria: 
gender: All
minimum age: 14 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Patricia A Arean, PhD
role: Principal Investigator
affiliation: University of Washington
last name: Brittany Mosser, MSW
phone: 206-616-2129
email: bmosser@uw.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Active, not recruiting
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Washington
investigator full name: Pat Arean
investigator title: Professor