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/NCT05990075</url>
    </required_header>
    <id_info>
      <org_study_id>CDX 21-002</org_study_id>
      <secondary_id>IK2HX002899-01A2</secondary_id>
      <nct_id>NCT05990075</nct_id>
    </id_info>
    <brief_title>An eHealth Intervention to Increase Depression Treatment Initiation and Adherence Among Veterans Referred for Mental Health Services</brief_title>
    <official_title>An eHealth Intervention to Increase Depression Treatment Initiation and Adherence Among Veterans Referred for Mental Health Services (CDA 18-189)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>VA Office of Research and Development</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>VA Office of Research and Development</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Depression is the most prevalent mental health condition among VHA patients and is strongly&#xD;
        associated with poor functioning, negative health outcomes, and suicide. Despite effective&#xD;
        and available treatments, engagement in care is poor. This study will analyze VHA electronic&#xD;
        medical record data, to identify patient characteristics associated with poor treatment&#xD;
        engagement. The study will then develop and formatively evaluate an eHealth intervention to&#xD;
        improve and sustain engagement in mental health care through self-monitoring. This is an&#xD;
        important step in engaging Veterans who, in part, based on their military training, may have&#xD;
        difficulty identifying or accepting depressed affect and the benefits of treatment. The&#xD;
        information obtained will inform clinical strategies and operations policy to improve&#xD;
        quality, coordination, and efficiency of mental health services.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        My goal is to optimize treatment outcomes for Veterans with depression. To experience&#xD;
        positive outcomes, Veterans must begin care promptly when needed and remain engaged in care.&#xD;
        Depression imposes a great burden of illness and disability for the OEF/OIF Veteran&#xD;
        population. As few as 30% of Veterans initiate treatment after referrals for mental health&#xD;
        services and adherence after initiation is low. Untreated depression is strongly linked to&#xD;
        suicide mortality, drug abuse, and persistent impairment leading to poor health outcomes. The&#xD;
        VHA has focused on increasing access to evidence-based treatments (EBTs) as the gold standard&#xD;
        for treating depression, however the guidelines do not address Veterans who are lost to care.&#xD;
        This is a missed opportunity to engage Veterans who fail to initiate traditional treatment or&#xD;
        drop out early, often due to discomfort and lack of awareness of certain depression symptoms&#xD;
        or need for care, which translates to reduced self-efficacy to engage. Furthermore,&#xD;
        measurement-based care-the utilization of systematic symptom assessments over time to drive&#xD;
        changes in treatment-is recommended for care in VHA. Patients at risk for dropping out of&#xD;
        care may find systematic assessments acceptable and effective for supporting engagement in&#xD;
        EBTs if their symptoms persist.&#xD;
  &#xD;
        This study addresses treatment initiation and adherence among depressed Veterans who are&#xD;
        referred to mental health care. Specifically, the investigators will test an innovative&#xD;
        self-monitoring program for Veterans with depression which has the potential to facilitate&#xD;
        both treatment uptake and sustained engagement. The proposed research will test a patient&#xD;
        centered, self-monitoring eHealth intervention focused on systematic measurement and feedback&#xD;
        for Veterans with depression, as well as supportive messages providing VA related information&#xD;
        and coping strategies that Veterans elect.&#xD;
  &#xD;
        The intervention will be initiated when patients are referred for care. This program will&#xD;
        continue to help Veterans monitor during treatment if they so desire, as self-monitoring has&#xD;
        been found to increase the likelihood of treatment response. The objectives of this study are&#xD;
        to formatively evaluate this process and provide preliminary support to then evaluate the&#xD;
        efficacy/effectiveness of this intervention in a future study.&#xD;
  &#xD;
        This project is aligned with the VHA HSR&amp;D priorities in mental health and improving access&#xD;
        to care and high-priority research topics for mental and behavioral health. Findings from&#xD;
        this study have the potential to lead to transdiagnostic research, especially for PTSD, TBI,&#xD;
        and suicide.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">May 31, 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>
      <intervention_model_description>The study employs a single group design given its focus on feasibility and acceptability.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>The primary goal of the study is feasibility and acceptability of methods.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Acceptability as assessed by rate of initiation and completion of the intervention</measure>
      <time_frame>From date of referral to date of initial psychotherapy session, up to 30 weeks.</time_frame>
      <description>Acceptability will be measured by number of Veterans who agree to participate in the study and initiate the intervention. This measure will also capture the % completion of the intervention.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility as assessed by rate of completion of individual tasks within intervention</measure>
      <time_frame>From date of referral to date of initial psychotherapy session, up to 30 weeks.</time_frame>
      <description>Feasibility will be measured by rate of completion of each task of the proposed intervention (surveys, texts), rate of technical difficulties, and rate of incomplete data.</description>
    </primary_outcome>
    <other_outcome>
      <measure>Effectiveness of intervention as assessed by rate of depression treatment initiation and adherence</measure>
      <time_frame>Date of initiation of psychotherapy up to 30 weeks.</time_frame>
      <description>The investigators will evaluate % mental health treatment initiation relative to the general population in the same clinics. This measure is experimental given that effectiveness is not yet the focus of this work given its preliminary stage.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Depression</condition>
    <arm_group>
      <arm_group_label>Self-monitoring</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This research study will evaluate a self-monitoring intervention to increase awareness, provide support, and promote motivation to initiate treatment after referral to mental health. The proposed intervention is a user-driven program delivered online and by mobile text. This will be initially piloted for acceptability among Veterans referred to mental health service for depression treatment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>self-monitoring</intervention_name>
      <description>This research study will evaluate a self-monitoring intervention to increase awareness, provide support, and promote motivation to initiate treatment after referral to mental health. The proposed intervention is a user-driven program delivered online and by mobile text. This will be initially piloted for acceptability among Veterans referred to mental health service for depression treatment.</description>
      <arm_group_label>Self-monitoring</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Veteran status&#xD;
  &#xD;
            -  Recent referral to VA general mental health clinics providing psychotherapy for&#xD;
               depression&#xD;
  &#xD;
            -  No gender or minorities will be excluded from this study&#xD;
  &#xD;
            -  All ages will be included&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Current/Past Bipolar disorder and Current Psychotic disorder: to avoid potential&#xD;
               exacerbation from treatment for depression&#xD;
  &#xD;
            -  Alcohol Use disorder or Substance Use disorder: Depression treatments cannot reverse&#xD;
               the adverse effects of substances on mood, and therefore impact on adherence and&#xD;
               treatment characteristics may be confounded&#xD;
  &#xD;
            -  Other current severe or unstable, psychiatric and medical disorders that necessitates&#xD;
               clinical management that can confound results (e.g., cancer [in chemotherapy],&#xD;
               suicidality, recent hospitalization [medical/surgical] for which recovery overlaps&#xD;
               with study onset and duration, open skull/brain injury, moderate to severe TBI)&#xD;
  &#xD;
            -  Moderate to severe cognitive impairment (SLUMS 20 and/or diagnosis in medical record)&#xD;
  &#xD;
            -  Potentially temporary states/situations that may significantly impair mood/capability&#xD;
               to engage in treatment: unstable environment that is not in one's control (e.g.,&#xD;
               homeless, temporary group home, extensive care taking duties)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Vanessa Panaite, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>James A. Haley Veterans' Hospital, Tampa, FL</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Vanessa Panaite, PhD</last_name>
      <phone>(813) 558-3979</phone>
      <email>vanessa.panaite2@va.gov</email>
    </overall_contact>
    <location>
      <facility>
        <name>James A. Haley Veterans' Hospital, Tampa, FL</name>
        <address>
          <city>Tampa</city>
          <state>Florida</state>
          <zip>33612</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Vanessa Panaite, PhD</last_name>
        <phone>813-558-3979</phone>
        <email>vanessa.panaite2@va.gov</email>
      </contact>
      <investigator>
        <last_name>Vanessa Panaite, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>depression</keyword>
    <keyword>treatment initiation</keyword>
    <keyword>treatment adherence</keyword>
    <keyword>treatment utilization</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>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05990075
  org study id: CDX 21-002
  secondary id: IK2HX002899-01A2
  nct id: NCT05990075
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Depression is the most prevalent mental health condition among VHA patients and is strongly
        associated with poor functioning, negative health outcomes, and suicide. Despite effective
        and available treatments, engagement in care is poor. This study will analyze VHA electronic
        medical record data, to identify patient characteristics associated with poor treatment
        engagement. The study will then develop and formatively evaluate an eHealth intervention to
        improve and sustain engagement in mental health care through self-monitoring. This is an
        important step in engaging Veterans who, in part, based on their military training, may have
        difficulty identifying or accepting depressed affect and the benefits of treatment. The
        information obtained will inform clinical strategies and operations policy to improve
        quality, coordination, and efficiency of mental health services.
  My goal is to optimize treatment outcomes for Veterans with depression. To experience
        positive outcomes, Veterans must begin care promptly when needed and remain engaged in care.
        Depression imposes a great burden of illness and disability for the OEF/OIF Veteran
        population. As few as 30% of Veterans initiate treatment after referrals for mental health
        services and adherence after initiation is low. Untreated depression is strongly linked to
        suicide mortality, drug abuse, and persistent impairment leading to poor health outcomes. The
        VHA has focused on increasing access to evidence-based treatments (EBTs) as the gold standard
        for treating depression, however the guidelines do not address Veterans who are lost to care.
        This is a missed opportunity to engage Veterans who fail to initiate traditional treatment or
        drop out early, often due to discomfort and lack of awareness of certain depression symptoms
        or need for care, which translates to reduced self-efficacy to engage. Furthermore,
        measurement-based care-the utilization of systematic symptom assessments over time to drive
        changes in treatment-is recommended for care in VHA. Patients at risk for dropping out of
        care may find systematic assessments acceptable and effective for supporting engagement in
        EBTs if their symptoms persist.
  
        This study addresses treatment initiation and adherence among depressed Veterans who are
        referred to mental health care. Specifically, the investigators will test an innovative
        self-monitoring program for Veterans with depression which has the potential to facilitate
        both treatment uptake and sustained engagement. The proposed research will test a patient
        centered, self-monitoring eHealth intervention focused on systematic measurement and feedback
        for Veterans with depression, as well as supportive messages providing VA related information
        and coping strategies that Veterans elect.
  
        The intervention will be initiated when patients are referred for care. This program will
        continue to help Veterans monitor during treatment if they so desire, as self-monitoring has
        been found to increase the likelihood of treatment response. The objectives of this study are
        to formatively evaluate this process and provide preliminary support to then evaluate the
        efficacy/effectiveness of this intervention in a future study.
  
        This project is aligned with the VHA HSR&D priorities in mental health and improving access
        to care and high-priority research topics for mental and behavioral health. Findings from
        this study have the potential to lead to transdiagnostic research, especially for PTSD, TBI,
        and suicide.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: The study employs a single group design given its focus on feasibility and acceptability.
  primary purpose: Health Services Research
  masking: None (Open Label)
  masking description: The primary goal of the study is feasibility and acceptability of methods.
  measure: Acceptability as assessed by rate of initiation and completion of the intervention
  time frame: From date of referral to date of initial psychotherapy session, up to 30 weeks.
  description: Acceptability will be measured by number of Veterans who agree to participate in the study and initiate the intervention. This measure will also capture the % completion of the intervention.
  measure: Feasibility as assessed by rate of completion of individual tasks within intervention
  time frame: From date of referral to date of initial psychotherapy session, up to 30 weeks.
  description: Feasibility will be measured by rate of completion of each task of the proposed intervention (surveys, texts), rate of technical difficulties, and rate of incomplete data.
  measure: Effectiveness of intervention as assessed by rate of depression treatment initiation and adherence
  time frame: Date of initiation of psychotherapy up to 30 weeks.
  description: The investigators will evaluate % mental health treatment initiation relative to the general population in the same clinics. This measure is experimental given that effectiveness is not yet the focus of this work given its preliminary stage.
  arm group label: Self-monitoring
  arm group type: Experimental
  description: This research study will evaluate a self-monitoring intervention to increase awareness, provide support, and promote motivation to initiate treatment after referral to mental health. The proposed intervention is a user-driven program delivered online and by mobile text. This will be initially piloted for acceptability among Veterans referred to mental health service for depression treatment.
  intervention type: Behavioral
  intervention name: self-monitoring
  description: This research study will evaluate a self-monitoring intervention to increase awareness, provide support, and promote motivation to initiate treatment after referral to mental health. The proposed intervention is a user-driven program delivered online and by mobile text. This will be initially piloted for acceptability among Veterans referred to mental health service for depression treatment.
  arm group label: Self-monitoring
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Vanessa Panaite, PhD
  role: Principal Investigator
  affiliation: James A. Haley Veterans' Hospital, Tampa, FL
  last name: Vanessa Panaite, PhD
  phone: (813) 558-3979
  email: vanessa.panaite2@va.gov
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Depression
  mesh term: Depressive Disorder
  sharing ipd: No