<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/NCT04416529</url>
  </required_header>
  <id_info>
    <org_study_id>16-0216-E</org_study_id>
    <nct_id>NCT04416529</nct_id>
  </id_info>
  <brief_title>Tele-Mindfulness for Dementia's Family Caregivers: a Randomized Trial With a Usual Care Control Group</brief_title>
  <official_title>Tele-Mindfulness for Dementia's Family Caregivers: a Randomized Trial With a Usual Care Control Group</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mount Sinai Hospital, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mount Sinai Hospital, Canada</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Family caregivers were recruited through a combinations of strategies including a larger&#xD;
      caregiving project and its partners, memory clinics, community outreach, online&#xD;
      advertisement, flyers and brochures and word of mouth. After the telephone screening,&#xD;
      eligible individuals were scheduled for an in-person baseline meeting at which they received&#xD;
      additional information about the study, signed a consent form, completed baseline outcome&#xD;
      measures and then were randomized to the intervention or control group using an online&#xD;
      randomization program (http://www.graphpad.com/quickcalcs/index.cfm). All participants&#xD;
      completed outcome measures immediately post-intervention for the intervention group and at 2&#xD;
      months for the control group and all participants completed follow-up outcome measures at 3&#xD;
      month following the baseline assessment. Participants in the intervention group completed a&#xD;
      practice log which was designed to track their daily practice of mindfulness at home. The&#xD;
      study was reviewed and approved by the Mount Sinai Hospital Research Ethics Board.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intervention (tele-MBCT) group Tele-MBCT was an 8-week program delivered to participants&#xD;
      online via a videoconferencing program called Zoom. Zoom is an Ontario Personal Health&#xD;
      Information Act (PHIPA) compliant videoconferencing program that provides remote&#xD;
      communication for one-to-one or group meetings. Signing up, one-to-one meetings and attending&#xD;
      a meeting as an invitee are free. The host of a group meeting is charged a monthly fee (CAD&#xD;
      14.99-19.99). All hosting fees were paid by the Sinai Health system.&#xD;
&#xD;
      Before starting the intervention, each participant's internet device was checked for&#xD;
      compatibility with Zoom. If the device was not compatible, the participant was loaned a&#xD;
      tablet for the duration of the intervention which was returned at the end of the study. Each&#xD;
      participant was also trained in the use of their device to connect and use the Zoom platform&#xD;
      and had an online intake interview with the tele-MBCT instructor.&#xD;
&#xD;
      Before each session, the host emailed the Zoom link to the participants. At the scheduled&#xD;
      time of each group session, participants joined the live streamed session via their computers&#xD;
      by using the link and following the on-screen instructions. During the live sessions, each&#xD;
      participant was able to see, hear and speak with the group leader and other group members and&#xD;
      they each could mute/unmute, turn on/off video, send messages via chat box and leave the&#xD;
      session at any time if necessary.&#xD;
&#xD;
      The tele-MBCT instructor was a mental health clinician at the Reitman Centre who had a&#xD;
      University of Toronto specialist and applied mindfulness certificate and mindfulness training&#xD;
      at Mount Sinai Psychotherapy Institute (MSPI). She had extensive experience in developing and&#xD;
      delivering online training and services to professionals and caregivers.&#xD;
&#xD;
      Participants in the intervention group were given a mindfulness package which included a book&#xD;
      called &quot;The Mindful Way Workbook&quot; (Teasdale, Williams, and Segal 2014), a practice log and a&#xD;
      snack pack of raisins (which was needed for the first session for mindful eating practice).&#xD;
      &quot;The Mindful Way Workbook&quot; contains information about emotional distress, MBCT foundation and&#xD;
      theories, other individuals' experiences with MBCT, weekly practices/explanations and&#xD;
      homework. The book also contains a CD audio guide to each week's mindfulness practice. The&#xD;
      practice log was a simple log for self-recording daily practices (number of minutes of daily&#xD;
      MBCT practice) and a note pad for recording the reasons/obstacles for not practicing. These&#xD;
      logs were anonymous and did not include any personal health information of the participants.&#xD;
      At the completion of the tele-MBCT training, participants submitted their logs for analysis.&#xD;
&#xD;
      Tele-MBCT was delivered in three, 8-week rounds. Each round consisted of 8 weekly, 2-hour&#xD;
      group sessions with 4-6 participants, held via Zoom on Wednesdays from 2:00 to 4:00 pm. For&#xD;
      any technical problems during the sessions, participants had telephone access to the&#xD;
      instructor.&#xD;
&#xD;
      During tele-MBCT training, participants were trained in mindfulness concepts and techniques&#xD;
      including mindful eating, body scan, sitting meditation, breathing awareness, mindful walking&#xD;
      and mindful movements. Mindfulness practices, except for mindful walking and mindful&#xD;
      movements, were done in a sitting position in a chair or standing. Participants were asked to&#xD;
      do the mindful walking with safety measures and in the room in which they were getting the&#xD;
      training. The mindful movements were gentle stretches performed in seated and standing&#xD;
      positions and were modified to each participant's abilities. At the completion of each&#xD;
      session, participants were instructed to practice a specific mindfulness exercise during the&#xD;
      week and record them in their practice log. They could use the CD for guided meditation and&#xD;
      their home practice. The book also provided them with further readings. At the beginning of&#xD;
      the training, participants were asked to set aside 30-45 minutes per day for practice.&#xD;
      However, they were free to practice based on their schedule. Participants were permitted to&#xD;
      miss up to 2 sessions for unanticipated problems. None of the sessions was audio/video&#xD;
      recorded. Missed sessions were made up by reading about the missed session and doing the&#xD;
      daily practice according to the book.&#xD;
&#xD;
      For this study, MBCT was modified in two ways for online delivery: omitting the retreat day&#xD;
      from the schedule and mindful movements in lying position. In face to face MBCT training, the&#xD;
      retreat day is held between sessions 6 and 7 and lasts 5-6 hours, during which individuals&#xD;
      spend most of the day together in silence, doing guided practices of the previous sessions.&#xD;
      Because of the long hours of the retreat day, it was deemed impractical in an online&#xD;
      intervention and omitted. Because of safety issues, it was necessary that all the&#xD;
      participants in the group could be seen (via their cameras) by the instructor during the&#xD;
      whole training by adjusting the individual's device and finding the best position. This issue&#xD;
      was addressed in the Zoom training and the interview with the instructor. Because doing the&#xD;
      mindful movement in the lying position required adjustment of the device during the session&#xD;
      which was time consuming and challenging, individuals were instructed to do mindful movements&#xD;
      only in standing and sitting positions. However, the instructor explained the mindful&#xD;
      movements in lying position and encouraged the participants to practice them at home.&#xD;
&#xD;
      Control Group Participants in the control group continued their usual caregiving activities.&#xD;
      At 3 months after completion follow-up surveys, they received the &quot;Mindful Way Workbook&quot; and&#xD;
      were offered the opportunity to attend the same tele-MBCT training after the study ended.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2016</start_date>
  <completion_date type="Actual">November 7, 2017</completion_date>
  <primary_completion_date type="Actual">September 7, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants were randomized to either the intervention group or the control group. All the participant were assessed at baseline, post-intervention and at 4-weeks follow-up.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Perceived Stress Scale (PSS)- 10-item version</measure>
    <time_frame>Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants</time_frame>
    <description>Participant's level of stress</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Center for Epidemiologic Studies Depression Scale (CES-D)</measure>
    <time_frame>Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants</time_frame>
    <description>Participant's symptoms of depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State Anxiety Subscale of the Spielberger State-Trait Anxiety Inventory (STAI-S)</measure>
    <time_frame>Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants</time_frame>
    <description>Current anxiety level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coping Inventory for Stressful Situations- short form CISS-SF</measure>
    <time_frame>Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants</time_frame>
    <description>Participants' coping responses to stressful situations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-compassion Scale (SCS)</measure>
    <time_frame>Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants</time_frame>
    <description>Participants' level of self-compassion</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Demographics</measure>
    <time_frame>At baseline</time_frame>
    <description>Age, gender, level of education, employment status, marital status, care-recipient type of dementia, caregiver relationship, living status of the caregiver and care-recipient and length of time as a caregiver.</description>
  </other_outcome>
  <other_outcome>
    <measure>Feasibility criteria</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Recruitment, retention and compliance rates</description>
  </other_outcome>
  <other_outcome>
    <measure>Compliance rate</measure>
    <time_frame>at 2 months (post-intervention) only for participants in the intervention group</time_frame>
    <description>Participant compliance rates were evaluated based on attendance and practice rate, ability to complete the practice log and satisfaction questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Level of Satisfaction</measure>
    <time_frame>at 2 months (post-intervention) only for participants in the intervention group</time_frame>
    <description>Participants' level of satisfaction with the intervention based on the satisfaction questionnaire that was designed for this study</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Caregivers</condition>
  <condition>Mindfulness</condition>
  <arm_group>
    <arm_group_label>Intervention (tele-MBCT) group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tele-MBCT was an 8-week program delivered to participants online via a videoconferencing program called Zoom by a tele-MBCT instructor. Tele-MBCT was delivered in three, 8-week rounds. Each round consisted of 8 weekly, 2-hour group sessions with 4-6 participants on Wednesdays from 2:00 to 4:00 pm. Participants were trained in mindfulness concepts and techniques including mindful eating, body scan, sitting meditation, breathing awareness, mindful walking and mindful movements. Participants were given a mindfulness a book called &quot;The Mindful Way Workbook&quot; and a practice log. The book was a guide for their daily practice at home and the practice log was a simple log for self-recording daily practices (number of minutes of daily MBCT practice) and a note pad for recording the reasons/obstacles for not practicing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the control group continued their usual caregiving activities.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tele-MBCT</intervention_name>
    <description>Please see arm/group description.</description>
    <arm_group_label>Intervention (tele-MBCT) group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-identification as a caregiver for a family member diagnosed with any type of&#xD;
             dementia&#xD;
&#xD;
          -  English literacy&#xD;
&#xD;
          -  Access to a home computer connected to the Internet&#xD;
&#xD;
          -  Basic familiarity with using a computer (the ability to check email and download&#xD;
             files)&#xD;
&#xD;
          -  Score at least 3 on the Single-item measure of self-perceived stress&#xD;
&#xD;
          -  Agree to not engage in any formal community-based caregiver support programs,&#xD;
             mind-body programs, or psychotherapy until they have completed training and follow-up&#xD;
             evaluations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active suicidality and self-harm ideas&#xD;
&#xD;
          -  Recent diagnosis of major depression, severe anxiety, psychosis, and bipolar disorder&#xD;
&#xD;
          -  Active substance misuse&#xD;
&#xD;
          -  Starting on a new psychotropic medication within three months prior to entry into the&#xD;
             study&#xD;
&#xD;
          -  Involved in formal, professionally led meditation, yoga, or tai chi programs in the&#xD;
             previous year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joel Sadavoy, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Psychiatry, University of Toronto</affiliation>
  </overall_official>
  <link>
    <url>http://www.graphpad.com/quickcalcs/index.cfm</url>
    <description>Program that was used for randomization</description>
  </link>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>family caregivers</keyword>
  <keyword>Dementia</keyword>
  <keyword>mindfulness</keyword>
  <keyword>Online</keyword>
  <keyword>Internet-based</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04416529
org study id: 16-0216-E
nct id: NCT04416529
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Family caregivers were recruited through a combinations of strategies including a larger
      caregiving project and its partners, memory clinics, community outreach, online
      advertisement, flyers and brochures and word of mouth. After the telephone screening,
      eligible individuals were scheduled for an in-person baseline meeting at which they received
      additional information about the study, signed a consent form, completed baseline outcome
      measures and then were randomized to the intervention or control group using an online
      randomization program (http://www.graphpad.com/quickcalcs/index.cfm). All participants
      completed outcome measures immediately post-intervention for the intervention group and at 2
      months for the control group and all participants completed follow-up outcome measures at 3
      month following the baseline assessment. Participants in the intervention group completed a
      practice log which was designed to track their daily practice of mindfulness at home. The
      study was reviewed and approved by the Mount Sinai Hospital Research Ethics Board.
Intervention (tele-MBCT) group Tele-MBCT was an 8-week program delivered to participants
      online via a videoconferencing program called Zoom. Zoom is an Ontario Personal Health
      Information Act (PHIPA) compliant videoconferencing program that provides remote
      communication for one-to-one or group meetings. Signing up, one-to-one meetings and attending
      a meeting as an invitee are free. The host of a group meeting is charged a monthly fee (CAD
      14.99-19.99). All hosting fees were paid by the Sinai Health system.

      Before starting the intervention, each participant's internet device was checked for
      compatibility with Zoom. If the device was not compatible, the participant was loaned a
      tablet for the duration of the intervention which was returned at the end of the study. Each
      participant was also trained in the use of their device to connect and use the Zoom platform
      and had an online intake interview with the tele-MBCT instructor.

      Before each session, the host emailed the Zoom link to the participants. At the scheduled
      time of each group session, participants joined the live streamed session via their computers
      by using the link and following the on-screen instructions. During the live sessions, each
      participant was able to see, hear and speak with the group leader and other group members and
      they each could mute/unmute, turn on/off video, send messages via chat box and leave the
      session at any time if necessary.

      The tele-MBCT instructor was a mental health clinician at the Reitman Centre who had a
      University of Toronto specialist and applied mindfulness certificate and mindfulness training
      at Mount Sinai Psychotherapy Institute (MSPI). She had extensive experience in developing and
      delivering online training and services to professionals and caregivers.

      Participants in the intervention group were given a mindfulness package which included a book
      called "The Mindful Way Workbook" (Teasdale, Williams, and Segal 2014), a practice log and a
      snack pack of raisins (which was needed for the first session for mindful eating practice).
      "The Mindful Way Workbook" contains information about emotional distress, MBCT foundation and
      theories, other individuals' experiences with MBCT, weekly practices/explanations and
      homework. The book also contains a CD audio guide to each week's mindfulness practice. The
      practice log was a simple log for self-recording daily practices (number of minutes of daily
      MBCT practice) and a note pad for recording the reasons/obstacles for not practicing. These
      logs were anonymous and did not include any personal health information of the participants.
      At the completion of the tele-MBCT training, participants submitted their logs for analysis.

      Tele-MBCT was delivered in three, 8-week rounds. Each round consisted of 8 weekly, 2-hour
      group sessions with 4-6 participants, held via Zoom on Wednesdays from 2:00 to 4:00 pm. For
      any technical problems during the sessions, participants had telephone access to the
      instructor.

      During tele-MBCT training, participants were trained in mindfulness concepts and techniques
      including mindful eating, body scan, sitting meditation, breathing awareness, mindful walking
      and mindful movements. Mindfulness practices, except for mindful walking and mindful
      movements, were done in a sitting position in a chair or standing. Participants were asked to
      do the mindful walking with safety measures and in the room in which they were getting the
      training. The mindful movements were gentle stretches performed in seated and standing
      positions and were modified to each participant's abilities. At the completion of each
      session, participants were instructed to practice a specific mindfulness exercise during the
      week and record them in their practice log. They could use the CD for guided meditation and
      their home practice. The book also provided them with further readings. At the beginning of
      the training, participants were asked to set aside 30-45 minutes per day for practice.
      However, they were free to practice based on their schedule. Participants were permitted to
      miss up to 2 sessions for unanticipated problems. None of the sessions was audio/video
      recorded. Missed sessions were made up by reading about the missed session and doing the
      daily practice according to the book.

      For this study, MBCT was modified in two ways for online delivery: omitting the retreat day
      from the schedule and mindful movements in lying position. In face to face MBCT training, the
      retreat day is held between sessions 6 and 7 and lasts 5-6 hours, during which individuals
      spend most of the day together in silence, doing guided practices of the previous sessions.
      Because of the long hours of the retreat day, it was deemed impractical in an online
      intervention and omitted. Because of safety issues, it was necessary that all the
      participants in the group could be seen (via their cameras) by the instructor during the
      whole training by adjusting the individual's device and finding the best position. This issue
      was addressed in the Zoom training and the interview with the instructor. Because doing the
      mindful movement in the lying position required adjustment of the device during the session
      which was time consuming and challenging, individuals were instructed to do mindful movements
      only in standing and sitting positions. However, the instructor explained the mindful
      movements in lying position and encouraged the participants to practice them at home.

      Control Group Participants in the control group continued their usual caregiving activities.
      At 3 months after completion follow-up surveys, they received the "Mindful Way Workbook" and
      were offered the opportunity to attend the same tele-MBCT training after the study ended.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants were randomized to either the intervention group or the control group. All the participant were assessed at baseline, post-intervention and at 4-weeks follow-up.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Perceived Stress Scale (PSS)- 10-item version
time frame: Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants
description: Participant's level of stress
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
time frame: Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants
description: Participant's symptoms of depression
measure: State Anxiety Subscale of the Spielberger State-Trait Anxiety Inventory (STAI-S)
time frame: Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants
description: Current anxiety level
measure: Coping Inventory for Stressful Situations- short form CISS-SF
time frame: Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants
description: Participants' coping responses to stressful situations
measure: Self-compassion Scale (SCS)
time frame: Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants
description: Participants' level of self-compassion
measure: Demographics
time frame: At baseline
description: Age, gender, level of education, employment status, marital status, care-recipient type of dementia, caregiver relationship, living status of the caregiver and care-recipient and length of time as a caregiver.
measure: Feasibility criteria
time frame: Through study completion, an average of 1 year
description: Recruitment, retention and compliance rates
measure: Compliance rate
time frame: at 2 months (post-intervention) only for participants in the intervention group
description: Participant compliance rates were evaluated based on attendance and practice rate, ability to complete the practice log and satisfaction questionnaire
measure: Level of Satisfaction
time frame: at 2 months (post-intervention) only for participants in the intervention group
description: Participants' level of satisfaction with the intervention based on the satisfaction questionnaire that was designed for this study
arm group label: Intervention (tele-MBCT) group
arm group type: Experimental
description: Tele-MBCT was an 8-week program delivered to participants online via a videoconferencing program called Zoom by a tele-MBCT instructor. Tele-MBCT was delivered in three, 8-week rounds. Each round consisted of 8 weekly, 2-hour group sessions with 4-6 participants on Wednesdays from 2:00 to 4:00 pm. Participants were trained in mindfulness concepts and techniques including mindful eating, body scan, sitting meditation, breathing awareness, mindful walking and mindful movements. Participants were given a mindfulness a book called "The Mindful Way Workbook" and a practice log. The book was a guide for their daily practice at home and the practice log was a simple log for self-recording daily practices (number of minutes of daily MBCT practice) and a note pad for recording the reasons/obstacles for not practicing.
arm group label: Control Group
arm group type: No Intervention
description: Participants in the control group continued their usual caregiving activities.
intervention type: Behavioral
intervention name: Tele-MBCT
description: Please see arm/group description.
arm group label: Intervention (tele-MBCT) group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Joel Sadavoy, MD, FRCPC
role: Principal Investigator
affiliation: Department of Psychiatry, University of Toronto
url: http://www.graphpad.com/quickcalcs/index.cfm
description: Program that was used for randomization
responsible party type: Sponsor
mesh term: Dementia
sharing ipd: No