<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/NCT04476667</url>
  </required_header>
  <id_info>
    <org_study_id>PSIY-683-20</org_study_id>
    <nct_id>NCT04476667</nct_id>
  </id_info>
  <brief_title>Online Delivery of Psychotherapy, Tailored to Patients' Suffering From Mental Health Problems Due to COVID-19</brief_title>
  <official_title>Online Delivery of Psychotherapy, Tailored to Patients' Suffering From Mental Health Problems Due to COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen's University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Online PsychoTherapy Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Queen's University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The recent COVID-19 pandemic has affected many aspects of individuals social life and its&#xD;
      negative consequences on Canadian public health go far beyond the direct overload of the&#xD;
      hospital care system. Self-isolation and financial uncertainty can significantly deteriorate&#xD;
      individuals' mental health, which is only going to aggravate with prolonged physical&#xD;
      distancing strategies. Adding to this is the personal and public trauma of lost lives and&#xD;
      soon there will be an unprecedented epidemic of mental health problems with crushing effects&#xD;
      on the public health sector and economy. To meet this huge new demand for an already strained&#xD;
      health system, there is a need for innovative new approaches that significantly expand the&#xD;
      capacity of care delivery. While it may not be possible in the short term to increase the&#xD;
      number of mental healthcare providers or the number of hours they work, improving their time&#xD;
      spent efficiently might be the solution. Virtual care and online delivery of psychotherapy,&#xD;
      shown to be clinically effective, efficient and cost-effective, might be the perfect solution&#xD;
      to address the high demand faced now. The investigators aim to establish the first academic&#xD;
      online psychotherapy clinic to manage mental health problems secondary to COVID-19. The goal&#xD;
      is to evaluate the feasibility and efficacy of treating COVID-19 related mental health issues&#xD;
      in this clinic, offering a 10-week, diagnosis-specific, online psychotherapy program. The&#xD;
      investigators will use the Online Psychotherapy Tool (OPTT), a secure cloud-based digital&#xD;
      mental health platform, developed by the PI, Dr. Alavi. Potentially, this method of care&#xD;
      delivery could increase care capacity by four-folds. The findings from this project have the&#xD;
      potential to influence clinical practice and policy and increase accessibility to care during&#xD;
      COVID-19 pandemic, without sacrificing the quality of care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants: Participants (n=80) aged 18-65 years will be recruited from referrals within&#xD;
      the outpatient clinics of HDH and PCH. Participants who consent to take part in the study&#xD;
      will be evaluated by one of the psychiatrists on the team through a video appointment.&#xD;
      Diagnosis of MDD and/or GAD will be confirmed using the DSM-5 and approved through the&#xD;
      M.I.N.I. The inclusion criteria for the study will include the capacity to consent; a&#xD;
      diagnosis of MDD and/or GAD, the ability to speak and read English, and having consistent and&#xD;
      reliable access to the internet. Exclusion criteria include active psychosis, acute mania,&#xD;
      severe alcohol or substance use disorder, and/or active suicidal or homicidal ideation. If a&#xD;
      participant is receiving another form of psychotherapy, they will also be excluded from the&#xD;
      study. If eligible for the study, participants will be randomly assigned to either the&#xD;
      electronic psychotherapy (e-psychotherapy) or control (i.e. Treatment as usual (TAU)) group,&#xD;
      stratified by sex, age group, and gender.&#xD;
&#xD;
      Participants selected for the e-psychotherapy group will receive a 9-week program that&#xD;
      includes a combination of CBT, mindfulness, and problem-based therapy, in addition to TAU.&#xD;
      The content of the e-psychotherapy program will be customized to reflect the challenges that&#xD;
      individuals face through the COVID-19 pandemic and will be developed into interactive and&#xD;
      engaging therapy modules. All online sessions and interactions will occur through Online&#xD;
      Psychotherapy Tool (OPTT), a secure online platform.&#xD;
&#xD;
      Through OPTT, all participants will be assigned to a team of psychiatrists and social workers&#xD;
      (SWs). The SW working with each patient will assign a pre-designed therapy module to that&#xD;
      patient on a specific day of the week through OPTT. Participants will then be able to access&#xD;
      the therapy content at any time throughout the week. Each weekly module will highlight a&#xD;
      different topic and include general information, an overview of skills, and homework that is&#xD;
      to be completed by a specific day that week. Completing each weekly module requires an&#xD;
      average time commitment of 40-minutes, which can be completed at once or in blocks of time.&#xD;
      This homework will be directly submitted through OPTT to the clinician who will then provide&#xD;
      personalized feedback to the patient. To ensure a consistent high-quality outcome, SWs will&#xD;
      use pre-designed session-specific feedback templates to respond to each weekly patient&#xD;
      submission. Each patient's care team will be able to securely communicate through OPTT to&#xD;
      make decisions regarding each patient's care path. The control group will receive treatment&#xD;
      as usual during the first 9 weeks; if they still present significant symptoms (less than 50%&#xD;
      response to treatment from baseline), they will be offered the e-psychotherapy program.&#xD;
&#xD;
      Module Content: The first 3 sessions will be designed to address the symptoms caused by fear&#xD;
      of illness or concerns about personal safety in the context of a pandemic. Electronic-CBT&#xD;
      (e-CBT) modules will focus on problem-solving techniques, with mindfulness practices&#xD;
      included, to help build healthy coping skills to address the uncertainties surrounding the&#xD;
      COVID-19 pandemic. e-CBT modules will involve guiding participants to develop constructive&#xD;
      and balanced coping strategies through 5 focuses: stimulus control, cognitive therapy, sleep&#xD;
      hygiene, relaxation therapy, and sleep restriction. Additional focus will be placed on the&#xD;
      connection between thoughts, behaviours, emotions, physical reaction and one's environment.&#xD;
&#xD;
      Training: Through training, all SWs will learn the standard care pathway, the aim, and the&#xD;
      content of each therapeutic session. Moreover, they will be provided sample homework from a&#xD;
      patient and asked to provide feedback. Feedback templates will vary from session to session&#xD;
      and SWs will personalize each template for each patients' homework. Training will occur&#xD;
      through webinars and exercises with feedback.&#xD;
&#xD;
      Outcome Evaluation: Primary outcomes measured will be stress level changes based on the&#xD;
      DASS-21, resilience based on RS-14, and quality of life-based on Q-LES-Q. Additional&#xD;
      measurements will be made based on participant diagnosis (PHQ9, MADRS, GAD7). All&#xD;
      questionnaires will be collected directly through OPTT at baseline, session 6, after the&#xD;
      final session, and at a 6-month follow up. Healthcare providers will be asked about the&#xD;
      feasibility of providing the e-psychotherapy, how it compared to in-person psychotherapy with&#xD;
      respect to time commitment, feelings of 'connectedness' to the participant, and any perceived&#xD;
      benefits/drawbacks to e-psychotherapy. From focus groups, factors related to personal,&#xD;
      social, and cultural factors (gender, sexuality, background, supportive resources,&#xD;
      structural/social barriers, etc.) will be extracted using an Interpretive Phenomenological&#xD;
      Analysis (IPA) approach.&#xD;
&#xD;
      Ethics and Data Privacy: All procedures have been submitted for approval of ethical&#xD;
      compliance to the Queen's University Health Sciences and Affiliated Teaching Hospitals&#xD;
      Research Ethics Board. Only the care providers involved in the care of the participant will&#xD;
      have access to their chart. Patients will only be identifiable by an ID number on the OPTT&#xD;
      platform and their real identity and consent forms will be stored locally in a locked file&#xD;
      cabinet and destroyed 5 years after the study completion date. Only anonymized data will be&#xD;
      provided to the analysis team members.&#xD;
&#xD;
      OPTT is HIPAA, PIPEDA and SOC-2 compliant and all servers and databases are hosted in AWS&#xD;
      Canada cloud infrastructure which is managed by Medstack to assure all provincial and federal&#xD;
      privacy and security regulations are met. OPTT will not collect any identifiable personal&#xD;
      information or IP addresses for privacy purposes. OPTT will only collect anonymized metadata&#xD;
      to improve its service quality and provide advanced analytics to the clinician team. All data&#xD;
      is encrypted by OPTT and no employee has direct access to patient data. All encrypted backups&#xD;
      are kept in the S3 storage that is dedicated to Queen's University.&#xD;
&#xD;
      Data Analysis: Repeated MANOVA will be used to evaluate treatment efficacy in changes in&#xD;
      scores on the DASS-21, RS-14 &amp; Q-LES-Q between the participant groups (TAU, anxiety, and&#xD;
      depression), and changes within each specific diagnosis at four different time points.&#xD;
      Thematic analysis will be applied to analyze survey questions in order to better capture&#xD;
      experiences, acceptability and patient-centeredness of e-psychotherapy. Descriptive analysis&#xD;
      of time spent by each care team member for individual participants to evaluate the cost&#xD;
      efficiency of care delivery will occur.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Actual">May 1, 2021</completion_date>
  <primary_completion_date type="Actual">May 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants selected for the e-psychotherapy group will receive a 9-week program that includes a combination of CBT, mindfulness, and problem-based therapy, in addition to TAU. The control group will receive treatment as usual during the first 9 weeks; if they still present significant symptoms (less than 50% response to treatment from baseline), they will be offered the e-psychotherapy program.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Stress</measure>
    <time_frame>Baseline, week 6, week 12</time_frame>
    <description>The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) - Scale: 0-3 (0 = never, 3 = frequently)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Resilience</measure>
    <time_frame>Baseline, week 6, week 12</time_frame>
    <description>14 Item Resilience Scale (RS-14) - Scale: 1-7 (1 = strongly disagree, 7 = strongly agree)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Quality of Life Assessment</measure>
    <time_frame>Baseline, week 6, week 12</time_frame>
    <description>The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Scale: 1-5 (1 = very poor, 5 = very good)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Symptom Severity - 1</measure>
    <time_frame>Baseline, week 6, week 12</time_frame>
    <description>Generalized Anxiety Disorder 7 (GAD-7) - Scale: 0-3 (0 = not at all, 3 = nearly every day)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Symptom Severity - 2</measure>
    <time_frame>Baseline, week 6, week 12</time_frame>
    <description>Montgomery-Asberg Depression Rating Scale (MADRS) - Scale: 0-6 (0 = not at all, 6 = frequent/very much)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Symptom Severity - 3</measure>
    <time_frame>Baseline, week 6, week 12</time_frame>
    <description>Patient Health Questionnaire 9 (PHQ-9) - Scale: 0-3 (0 = not at all, 3 = nearly every day)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Qualitative Information: Healthcare Providers</measure>
    <time_frame>Week 12</time_frame>
    <description>Healthcare providers who administered the e-psychotherapy for duration of project will be asked through focus groups questions surrounding the feasibility of providing the e-psychotherapy, how it compared to in-person psychotherapy with respect to time commitment, feelings of 'connectedness' to participant, and any perceived benefits/drawbacks to e-psychotherapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative Information: Personal, social, and cultural factors</measure>
    <time_frame>Week 12</time_frame>
    <description>In focus groups, participants will be asked questions regarding personal, social, and cultural factors (gender, sexuality, background, supportive resources, structural/social barriers, etc.) that could impact participant experience with e-psychotherapy. This will be extracted using an Interpretive Phenomenological Analysis (IPA) approach.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Mental Health Issue</condition>
  <condition>Covid19</condition>
  <condition>Anxiety Disorders</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>e-Psychotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a 9-week program with CBT, mindfulness, and problem-based therapy, in addition to TAU. The content will be customized to reflect challenges faced through the COVID-19 pandemic and developed into interactive and engaging modules. All sessions and interactions will occur through Online Psychotherapy Tool (OPTT), a secure online platform. Participants will be assigned to a team of psychiatrists and social workers (SWs). The SW working with each patient will assign a pre-designed therapy module to that patient on a specific day of the week through OPTT. Participants will then be able to access the therapy content at any time throughout the week. Each module will highlight a different topic and include general information, an overview of skills, and homework that is to be completed by a specific day that week. This homework will be directly submitted through OPTT to the clinician who will provide personalized feedback to the patient.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will receive treatment as usual during the first 9 weeks; if they still present significant symptoms (less than 50% response to treatment from baseline), they will be offered the e-psychotherapy program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>e-Psychotherapy</intervention_name>
    <description>Module Content: The first 3 sessions will be designed to address the symptoms caused by fear of illness or concerns about personal safety in the context of pandemic. Electronic-CBT (e-CBT) modules will focus on problem solving techniques, with mindfulness practices included, to help build healthy coping skills to address the uncertainties surrounding the COVID-19 pandemic. e-CBT modules will involve guiding participants to develop constructive and balanced coping strategies through 5 focuses: stimulus control, cognitive therapy, sleep hygiene, relaxation therapy, and sleep restriction. Additional focus will be placed on the connection between thoughts, behaviours, emotions, physical reaction and one's environment.</description>
    <arm_group_label>e-Psychotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Capacity to consent&#xD;
&#xD;
          -  Diagnosis of MDD and/or GAD&#xD;
&#xD;
          -  Ability to speak and read English&#xD;
&#xD;
          -  Consistent and reliable access to the internet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active psychosis&#xD;
&#xD;
          -  Acute mania&#xD;
&#xD;
          -  Severe alcohol or substance use disorder&#xD;
&#xD;
          -  Active suicidal or homicidal ideation&#xD;
&#xD;
          -  Participant receiving another form of psychotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nazanin Alavi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Queen's University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hotel Dieu Hospital</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 5G3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>September 7, 2021</last_update_submitted>
  <last_update_submitted_qc>September 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Queen's University</investigator_affiliation>
    <investigator_full_name>Dr. Nazanin Alavi</investigator_full_name>
    <investigator_title>Principal Investigator, Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Anxiety</keyword>
  <keyword>Depression</keyword>
  <keyword>COVID-19</keyword>
  <keyword>Online Psychotherapy</keyword>
  <keyword>Mental Health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Ethics and Data Privacy: Only care providers involved in care of participant will have access to charts. Patients will only be identifiable by ID number on OPTT platform and real identity and consent forms will be stored locally in locked file cabinet and destroyed 5 years after study completion date. Only anonymized data will be provided to analysis team members.&#xD;
OPTT is HIPAA, PIPEDA and SOC-2 compliant and all servers and databases are hosted in AWS Canada cloud infrastructure which is managed by Medstack to assure all provincial and federal privacy and security regulations are met. OPTT will not collect any identifiable personal information or IP addresses for privacy purposes. OPTT will only collect anonymized metadata to improve its service quality and provide advanced analytics to the clinician team. All data is encrypted by OPTT and no employee has direct access to patient data. All encrypted backups are kept in the S3 storage that is dedicated to Queen's University.</ipd_description>
  </patient_data>
  <!-- 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/NCT04476667
org study id: PSIY-683-20
nct id: NCT04476667
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The recent COVID-19 pandemic has affected many aspects of individuals social life and its
      negative consequences on Canadian public health go far beyond the direct overload of the
      hospital care system. Self-isolation and financial uncertainty can significantly deteriorate
      individuals' mental health, which is only going to aggravate with prolonged physical
      distancing strategies. Adding to this is the personal and public trauma of lost lives and
      soon there will be an unprecedented epidemic of mental health problems with crushing effects
      on the public health sector and economy. To meet this huge new demand for an already strained
      health system, there is a need for innovative new approaches that significantly expand the
      capacity of care delivery. While it may not be possible in the short term to increase the
      number of mental healthcare providers or the number of hours they work, improving their time
      spent efficiently might be the solution. Virtual care and online delivery of psychotherapy,
      shown to be clinically effective, efficient and cost-effective, might be the perfect solution
      to address the high demand faced now. The investigators aim to establish the first academic
      online psychotherapy clinic to manage mental health problems secondary to COVID-19. The goal
      is to evaluate the feasibility and efficacy of treating COVID-19 related mental health issues
      in this clinic, offering a 10-week, diagnosis-specific, online psychotherapy program. The
      investigators will use the Online Psychotherapy Tool (OPTT), a secure cloud-based digital
      mental health platform, developed by the PI, Dr. Alavi. Potentially, this method of care
      delivery could increase care capacity by four-folds. The findings from this project have the
      potential to influence clinical practice and policy and increase accessibility to care during
      COVID-19 pandemic, without sacrificing the quality of care.
Participants: Participants (n=80) aged 18-65 years will be recruited from referrals within
      the outpatient clinics of HDH and PCH. Participants who consent to take part in the study
      will be evaluated by one of the psychiatrists on the team through a video appointment.
      Diagnosis of MDD and/or GAD will be confirmed using the DSM-5 and approved through the
      M.I.N.I. The inclusion criteria for the study will include the capacity to consent; a
      diagnosis of MDD and/or GAD, the ability to speak and read English, and having consistent and
      reliable access to the internet. Exclusion criteria include active psychosis, acute mania,
      severe alcohol or substance use disorder, and/or active suicidal or homicidal ideation. If a
      participant is receiving another form of psychotherapy, they will also be excluded from the
      study. If eligible for the study, participants will be randomly assigned to either the
      electronic psychotherapy (e-psychotherapy) or control (i.e. Treatment as usual (TAU)) group,
      stratified by sex, age group, and gender.

      Participants selected for the e-psychotherapy group will receive a 9-week program that
      includes a combination of CBT, mindfulness, and problem-based therapy, in addition to TAU.
      The content of the e-psychotherapy program will be customized to reflect the challenges that
      individuals face through the COVID-19 pandemic and will be developed into interactive and
      engaging therapy modules. All online sessions and interactions will occur through Online
      Psychotherapy Tool (OPTT), a secure online platform.

      Through OPTT, all participants will be assigned to a team of psychiatrists and social workers
      (SWs). The SW working with each patient will assign a pre-designed therapy module to that
      patient on a specific day of the week through OPTT. Participants will then be able to access
      the therapy content at any time throughout the week. Each weekly module will highlight a
      different topic and include general information, an overview of skills, and homework that is
      to be completed by a specific day that week. Completing each weekly module requires an
      average time commitment of 40-minutes, which can be completed at once or in blocks of time.
      This homework will be directly submitted through OPTT to the clinician who will then provide
      personalized feedback to the patient. To ensure a consistent high-quality outcome, SWs will
      use pre-designed session-specific feedback templates to respond to each weekly patient
      submission. Each patient's care team will be able to securely communicate through OPTT to
      make decisions regarding each patient's care path. The control group will receive treatment
      as usual during the first 9 weeks; if they still present significant symptoms (less than 50%
      response to treatment from baseline), they will be offered the e-psychotherapy program.

      Module Content: The first 3 sessions will be designed to address the symptoms caused by fear
      of illness or concerns about personal safety in the context of a pandemic. Electronic-CBT
      (e-CBT) modules will focus on problem-solving techniques, with mindfulness practices
      included, to help build healthy coping skills to address the uncertainties surrounding the
      COVID-19 pandemic. e-CBT modules will involve guiding participants to develop constructive
      and balanced coping strategies through 5 focuses: stimulus control, cognitive therapy, sleep
      hygiene, relaxation therapy, and sleep restriction. Additional focus will be placed on the
      connection between thoughts, behaviours, emotions, physical reaction and one's environment.

      Training: Through training, all SWs will learn the standard care pathway, the aim, and the
      content of each therapeutic session. Moreover, they will be provided sample homework from a
      patient and asked to provide feedback. Feedback templates will vary from session to session
      and SWs will personalize each template for each patients' homework. Training will occur
      through webinars and exercises with feedback.

      Outcome Evaluation: Primary outcomes measured will be stress level changes based on the
      DASS-21, resilience based on RS-14, and quality of life-based on Q-LES-Q. Additional
      measurements will be made based on participant diagnosis (PHQ9, MADRS, GAD7). All
      questionnaires will be collected directly through OPTT at baseline, session 6, after the
      final session, and at a 6-month follow up. Healthcare providers will be asked about the
      feasibility of providing the e-psychotherapy, how it compared to in-person psychotherapy with
      respect to time commitment, feelings of 'connectedness' to the participant, and any perceived
      benefits/drawbacks to e-psychotherapy. From focus groups, factors related to personal,
      social, and cultural factors (gender, sexuality, background, supportive resources,
      structural/social barriers, etc.) will be extracted using an Interpretive Phenomenological
      Analysis (IPA) approach.

      Ethics and Data Privacy: All procedures have been submitted for approval of ethical
      compliance to the Queen's University Health Sciences and Affiliated Teaching Hospitals
      Research Ethics Board. Only the care providers involved in the care of the participant will
      have access to their chart. Patients will only be identifiable by an ID number on the OPTT
      platform and their real identity and consent forms will be stored locally in a locked file
      cabinet and destroyed 5 years after the study completion date. Only anonymized data will be
      provided to the analysis team members.

      OPTT is HIPAA, PIPEDA and SOC-2 compliant and all servers and databases are hosted in AWS
      Canada cloud infrastructure which is managed by Medstack to assure all provincial and federal
      privacy and security regulations are met. OPTT will not collect any identifiable personal
      information or IP addresses for privacy purposes. OPTT will only collect anonymized metadata
      to improve its service quality and provide advanced analytics to the clinician team. All data
      is encrypted by OPTT and no employee has direct access to patient data. All encrypted backups
      are kept in the S3 storage that is dedicated to Queen's University.

      Data Analysis: Repeated MANOVA will be used to evaluate treatment efficacy in changes in
      scores on the DASS-21, RS-14 & Q-LES-Q between the participant groups (TAU, anxiety, and
      depression), and changes within each specific diagnosis at four different time points.
      Thematic analysis will be applied to analyze survey questions in order to better capture
      experiences, acceptability and patient-centeredness of e-psychotherapy. Descriptive analysis
      of time spent by each care team member for individual participants to evaluate the cost
      efficiency of care delivery will occur.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Participants selected for the e-psychotherapy group will receive a 9-week program that includes a combination of CBT, mindfulness, and problem-based therapy, in addition to TAU. The control group will receive treatment as usual during the first 9 weeks; if they still present significant symptoms (less than 50% response to treatment from baseline), they will be offered the e-psychotherapy program.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Stress
time frame: Baseline, week 6, week 12
description: The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) - Scale: 0-3 (0 = never, 3 = frequently)
measure: Change in Resilience
time frame: Baseline, week 6, week 12
description: 14 Item Resilience Scale (RS-14) - Scale: 1-7 (1 = strongly disagree, 7 = strongly agree)
measure: Change in Quality of Life Assessment
time frame: Baseline, week 6, week 12
description: The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) - Scale: 1-5 (1 = very poor, 5 = very good)
measure: Change in Symptom Severity - 1
time frame: Baseline, week 6, week 12
description: Generalized Anxiety Disorder 7 (GAD-7) - Scale: 0-3 (0 = not at all, 3 = nearly every day)
measure: Change in Symptom Severity - 2
time frame: Baseline, week 6, week 12
description: Montgomery-Asberg Depression Rating Scale (MADRS) - Scale: 0-6 (0 = not at all, 6 = frequent/very much)
measure: Change in Symptom Severity - 3
time frame: Baseline, week 6, week 12
description: Patient Health Questionnaire 9 (PHQ-9) - Scale: 0-3 (0 = not at all, 3 = nearly every day)
measure: Qualitative Information: Healthcare Providers
time frame: Week 12
description: Healthcare providers who administered the e-psychotherapy for duration of project will be asked through focus groups questions surrounding the feasibility of providing the e-psychotherapy, how it compared to in-person psychotherapy with respect to time commitment, feelings of 'connectedness' to participant, and any perceived benefits/drawbacks to e-psychotherapy.
measure: Qualitative Information: Personal, social, and cultural factors
time frame: Week 12
description: In focus groups, participants will be asked questions regarding personal, social, and cultural factors (gender, sexuality, background, supportive resources, structural/social barriers, etc.) that could impact participant experience with e-psychotherapy. This will be extracted using an Interpretive Phenomenological Analysis (IPA) approach.
arm group label: e-Psychotherapy
arm group type: Experimental
description: Participants will receive a 9-week program with CBT, mindfulness, and problem-based therapy, in addition to TAU. The content will be customized to reflect challenges faced through the COVID-19 pandemic and developed into interactive and engaging modules. All sessions and interactions will occur through Online Psychotherapy Tool (OPTT), a secure online platform. Participants will be assigned to a team of psychiatrists and social workers (SWs). The SW working with each patient will assign a pre-designed therapy module to that patient on a specific day of the week through OPTT. Participants will then be able to access the therapy content at any time throughout the week. Each module will highlight a different topic and include general information, an overview of skills, and homework that is to be completed by a specific day that week. This homework will be directly submitted through OPTT to the clinician who will provide personalized feedback to the patient.
arm group label: Treatment as Usual
arm group type: No Intervention
description: The control group will receive treatment as usual during the first 9 weeks; if they still present significant symptoms (less than 50% response to treatment from baseline), they will be offered the e-psychotherapy program.
intervention type: Behavioral
intervention name: e-Psychotherapy
description: Module Content: The first 3 sessions will be designed to address the symptoms caused by fear of illness or concerns about personal safety in the context of pandemic. Electronic-CBT (e-CBT) modules will focus on problem solving techniques, with mindfulness practices included, to help build healthy coping skills to address the uncertainties surrounding the COVID-19 pandemic. e-CBT modules will involve guiding participants to develop constructive and balanced coping strategies through 5 focuses: stimulus control, cognitive therapy, sleep hygiene, relaxation therapy, and sleep restriction. Additional focus will be placed on the connection between thoughts, behaviours, emotions, physical reaction and one's environment.
arm group label: e-Psychotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Nazanin Alavi
role: Principal Investigator
affiliation: Queen's University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Queen's University
investigator full name: Dr. Nazanin Alavi
investigator title: Principal Investigator, Assistant Professor
mesh term: COVID-19
mesh term: Depression
mesh term: Anxiety Disorders
sharing ipd: No
ipd description: Ethics and Data Privacy: Only care providers involved in care of participant will have access to charts. Patients will only be identifiable by ID number on OPTT platform and real identity and consent forms will be stored locally in locked file cabinet and destroyed 5 years after study completion date. Only anonymized data will be provided to analysis team members.
OPTT is HIPAA, PIPEDA and SOC-2 compliant and all servers and databases are hosted in AWS Canada cloud infrastructure which is managed by Medstack to assure all provincial and federal privacy and security regulations are met. OPTT will not collect any identifiable personal information or IP addresses for privacy purposes. OPTT will only collect anonymized metadata to improve its service quality and provide advanced analytics to the clinician team. All data is encrypted by OPTT and no employee has direct access to patient data. All encrypted backups are kept in the S3 storage that is dedicated to Queen's University.