<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/NCT03267953</url>
  </required_header>
  <id_info>
    <org_study_id>SMHC 17 11</org_study_id>
    <nct_id>NCT03267953</nct_id>
  </id_info>
  <brief_title>Adaptive Internet-based Stress Management Among Adults With a Cardiovascular Disease: A Pilot Sequential Multiple Assignment Randomized Trial (SMART) Design</brief_title>
  <official_title>Adaptive Internet-based Stress Management Among Adults With a Cardiovascular Disease: A Pilot Sequential Multiple Assignment Randomized Trial (SMART) Design</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Mary's Research Center, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>McGill University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Mary's Research Center, 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>
      Internet-based stress management programs adapted to patients' needs&#xD;
&#xD;
      Stress is inevitable, and it has many negative consequences on the health of everybody, but&#xD;
      particularly on the health of patients with a cardiovascular disease (CVD). The good news is&#xD;
      that patients with CVD can learn to better control their stress through stress management&#xD;
      programs. Most stress management programs are offered face-to-face by a trained health care&#xD;
      professional. Research has shown that these programs have a positive impact on the health of&#xD;
      patients with CVD, including reducing mortality and other risk factors that can make the&#xD;
      disease worse (e.g., reduces blood pressure). Because of these benefits, the recommendation&#xD;
      is to offer a stress management program to as many patients with CVD as possible. The problem&#xD;
      is that their delivery is challenging for most clinics (e.g., too costly to run, health care&#xD;
      professionals are not available). This means many good stress management programs never make&#xD;
      it to the patient. Patients also face barriers in accessing traditional stress management&#xD;
      programs such as stigma or need to travel. Therefore, new approaches are needed to allow&#xD;
      findings from research to actually have an impact on the public's health.&#xD;
&#xD;
      One of these approaches is to use the internet to deliver stress management programs. The&#xD;
      internet has now been used for about 10 years to deliver a range of programs to patients.&#xD;
      There are limitations to this approach as well. For instance, 40-60% of patients who will use&#xD;
      an internet-based program will not benefit from it. These patients need more support or&#xD;
      guidance to get the most out of their internet-based program. This is the problem addressed&#xD;
      using the proposed innovative trial design. Investigators aim to improve the number of&#xD;
      patients with CVD who improve after receiving a stress management program by changing the&#xD;
      type and level of support they receive over time. This type of innovative trial design is&#xD;
      more and more popular, but has never been used to enhance a stress management programs for&#xD;
      patients with CVD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND: Stress has a negative impact on the experience of individuals with a&#xD;
      cardiovascular disease-both directly (e.g., physiologic effects of stress may worsen&#xD;
      cardiovascular disease) and indirectly (e.g., leads to higher perceived symptom severity).&#xD;
      Therefore, stress management has become an extensively researched form of psychological&#xD;
      therapy for these individuals, and is increasingly offered through the internet. Advantages&#xD;
      of internet-based interventions include being time efficient (e.g., cut travel time),&#xD;
      reducing waiting-lists, and increasing access for some sub-groups of the population (e.g.,&#xD;
      those living in rural and remote areas). Internet-based interventions also have the potential&#xD;
      to integrate effective features of face-to-face interventions (e.g., tailored feedback,&#xD;
      monitoring), but offer the scalability needed for public health interventions. However, up to&#xD;
      60% of individuals do not respond to these interventions, and for these individuals offering&#xD;
      different types of support or increasing the intensity of the support provided is necessary.&#xD;
      An innovative trial design to develop time-varying, adaptive interventions to maximize&#xD;
      clinical effectiveness is the Sequential multiple assignment randomized trials (SMARTs).&#xD;
      However, despite increasing popularity, SMARTs remain relatively new to intervention&#xD;
      researchers.&#xD;
&#xD;
      GOAL AND OBJECTIVES: The goal of this pilot Sequential Multiple Assignment Randomized Trial&#xD;
      (SMART) is to inform the planning of a subsequent larger SMART to evaluate an adaptive&#xD;
      internet-based stress management program that follows a stepped-care model for adults with a&#xD;
      cardiovascular disease. The primary objectives are to examine the (a) feasibility of the&#xD;
      SMART procedures and different combinations of the stress management program (recruitment,&#xD;
      retention, and questionnaire completion rates, reach, and fidelity) and (b) acceptability of&#xD;
      the combinations of the stress management program, including adapting the program for&#xD;
      non-responders and assessing adherence, satisfaction, and stress management strategies&#xD;
      learned. The secondary objective is to estimate the program's effect size to inform sample&#xD;
      size calculations for a full-scale SMART.&#xD;
&#xD;
      METHODOLOGY: 56 patients with a physician confirmed diagnosis of a cardiovascular disease&#xD;
      will be recruited through clinic referrals and community-based study advertisement. Inclusion&#xD;
      criteria are: (a) moderate stress (stress subscale score of 15 or more on Depression,&#xD;
      Anxiety, and Stress Scale), (b) at least 18 years of age, (c) not participated in a stress&#xD;
      management intervention in the past year, (e) regular access to a computer with internet and&#xD;
      e-mail capabilities, and (f) reports understanding English or French. Eligibility will be&#xD;
      confirmed mainly by self-report at the time of a screening interview. After completing their&#xD;
      consent form and baseline questionnaire (T0), participants will be randomized to either: (a)&#xD;
      a 6-week self-directed, web-based stress management program or (b) the same program plus&#xD;
      weekly lay coaching. At the end of 6 weeks, intervention response will be assessed (T1&#xD;
      questionnaire), and non-responders will include those who have a stress score that did not&#xD;
      improve (i.e., less than 50% decrease) or have a stress score above the cut-off point for&#xD;
      mild stress (primary tailoring variable). In both groups, non-responders will then be&#xD;
      randomized a second time to either (a) continue with their first stage program or (b)&#xD;
      professionally-led motivational interviewing for another 6 weeks. During this time,&#xD;
      responders will continue their first stage programs. The internet-based stress management&#xD;
      program is available through my Health CheckUp. All participants will then complete their&#xD;
      12-13 weeks follow-up questionnaire (T2) to examine changes in stress and quality of life&#xD;
      (primary outcomes), anxiety, depression, illness appraisal, self-efficacy, physical activity,&#xD;
      and coping (secondary outcomes). Acceptability will be assessed by the satisfaction measure&#xD;
      included in the follow-up questionnaire and further explored during an exit interview with&#xD;
      participants. Feasibility measures will focus on the characteristics of the participants&#xD;
      reached, protocol fidelity, percent of missing data, and recruitment and retention rates.&#xD;
&#xD;
      SIGNIFICANCE: The potential reach of internet-based interventions promises considerable&#xD;
      public health impact. However, to maximize impact, the most effective interventions need to&#xD;
      be developed and adapted to patients' evolving needs. This study will use the innovative&#xD;
      SMART design to evaluate an adaptive internet-based intervention for individuals with a&#xD;
      physical chronic illness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 30, 2017</start_date>
  <completion_date type="Actual">August 31, 2019</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</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>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility</measure>
    <time_frame>Recruitment over 6 months, participant follow-up over 13 weeks</time_frame>
    <description>defined as the practicality of implementing the SMART procedures and of offering different types and levels of support in conjunction with an Internet-based stress management program. Feasibility measures include fidelity, reach, recruitment rate, and questionnaire completion rates.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability</measure>
    <time_frame>Recruitment over 6 months, participant follow-up over 13 weeks</time_frame>
    <description>defined as patients' views of the programs, and will include satisfaction with the different types of support offered, appropriateness of adapting the programs for non-responders, examining attrition, and assessing adherence and skills learned.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical significance</measure>
    <time_frame>At T2: 12-13 weeks</time_frame>
    <description>clinical significance of adapting the type and level of support provided on the primary and secondary outcomes of interest.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Stress</measure>
    <time_frame>At T0 (Baseline), T1 (6 weeks) and T2 (12-13 weeks)</time_frame>
    <description>Measured with the Depression, Anxiety, and Stress Scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life</measure>
    <time_frame>At T0 (Baseline), T1 (6 weeks) and T2 (12-13 weeks)</time_frame>
    <description>Measured with the SF-12</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Stress, Psychological</condition>
  <arm_group>
    <arm_group_label>First stage: Self-directed My Health CheckUp</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to this group will be sent an e-mail invitation by the research team to register to the website. Once registered, participants will receive a second e-mail that will provide brief instructions on getting started and invite them to use the website for 12 weeks ad libitum. No additional contact will be provided thereafter by research team.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>First stage: Minimally guided My Health CheckUp.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will also be invited to use the 12-week Internet-based stress management program, but they will additionally receive support via weekly telephone calls from a lay coach.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Second stage: High intensity Motivational Interviewing (MI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After 6 weeks, response to the first stage programs will be assessed and only the non-responders will be randomized a second time to (a) continue with the first stage programs or (b) High-intensity MI. In addition to continued access to My Health CheckUp, participants in this group will also be supported with 6 weekly, telephone-based MI sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>My Health CheckUp Online Stress Management Program</intervention_name>
    <description>Self-contained, web-based, stress management program developed by team of health care professionals, designed to encourage patients to learn evidence-based cognitive and behavioural strategies to effectively manage stress. Health risk appraisals include evidence-based recommendations to address risks. Stress management modules include education about the impact of stress, self-monitoring through a stress diary, and using four key strategies: physical activity, deep breathing and relaxation, problem-solving/addressing negative thoughts, and sleep hygiene. Through the modules, patients will learn new stress management strategies and have an opportunity to practice these, track their progress, and obtain feedback via the website. To facilitate self-monitoring of stress levels and tracking of strategies such as physical activity, tracking tools can be used on mobile devices.</description>
    <arm_group_label>First stage: Minimally guided My Health CheckUp.</arm_group_label>
    <arm_group_label>First stage: Self-directed My Health CheckUp</arm_group_label>
    <arm_group_label>Second stage: High intensity Motivational Interviewing (MI)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lay telephone coaching</intervention_name>
    <description>The goal of telephone coaching will be to provide brief encouragement on how to use the modules; however, no formal therapy will be provided. Sessions will range between 10-15 minutes. Each coach session will follow the process outlined by the GROW model, which stands for Goal, Reality, Options/Obstacles, and Will/Way forward. The sessions will start with the coach and participant agreeing on the topics for discussion and desired outcomes (goal). Then, coaches will explore the use of the intervention over the previous week, guide participants through the modules, identify barriers to using these modules, offer advice to overcome these barriers, and provide positive reinforcement. The development of an action plan for the following week will conclude each session. The short Perceived Stress Scale will be used at the end of each session to monitor progress. A script will guide the lay coach through each call.</description>
    <arm_group_label>First stage: Minimally guided My Health CheckUp.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Motivational interviewing (telephone)</intervention_name>
    <description>Sessions will range from 30 to 45 minutes. The goal of MI is to strengthen patients' motivation and confidence for adopting the stress management strategies suggested. The MI practitioner's interventions are based on the four processes of MI: Engaging, Focusing, Evoking, and Planning.</description>
    <arm_group_label>Second stage: High intensity Motivational Interviewing (MI)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  physician-confirmed diagnosis of a CVD (at least 3 months since most recent diagnosis)&#xD;
&#xD;
          -  moderate stress as indicated by a score of &gt; 15 on the stress subscale of the&#xD;
             Depression, Anxiety, and Stress Scale (DASS)&#xD;
&#xD;
          -  regular access to a computer with Internet and e-mail capabilities&#xD;
&#xD;
          -  understands English or French&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  participated in a stress management program in the past year&#xD;
&#xD;
          -  hospitalized or living in a long-term care residence&#xD;
&#xD;
          -  moderate-severe cognitive impairment (Blessed Orientation-Memory-Concentration test&#xD;
             score 10+)&#xD;
&#xD;
          -  severe stress (DASS stress score &gt; 34)&#xD;
&#xD;
          -  suicidal intent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sylvie D Lambert, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McGill University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St Mary's Hospital Centre</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3T1M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>November 1, 2019</last_update_submitted>
  <last_update_submitted_qc>November 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University</investigator_affiliation>
    <investigator_full_name>Sylvie Lambert</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Stress management, e-Health, cardiovascular disease, adaptive design, lay coaching, motivational interviewing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Stress, Psychological</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/NCT03267953
org study id: SMHC 17 11
nct id: NCT03267953
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Internet-based stress management programs adapted to patients' needs

      Stress is inevitable, and it has many negative consequences on the health of everybody, but
      particularly on the health of patients with a cardiovascular disease (CVD). The good news is
      that patients with CVD can learn to better control their stress through stress management
      programs. Most stress management programs are offered face-to-face by a trained health care
      professional. Research has shown that these programs have a positive impact on the health of
      patients with CVD, including reducing mortality and other risk factors that can make the
      disease worse (e.g., reduces blood pressure). Because of these benefits, the recommendation
      is to offer a stress management program to as many patients with CVD as possible. The problem
      is that their delivery is challenging for most clinics (e.g., too costly to run, health care
      professionals are not available). This means many good stress management programs never make
      it to the patient. Patients also face barriers in accessing traditional stress management
      programs such as stigma or need to travel. Therefore, new approaches are needed to allow
      findings from research to actually have an impact on the public's health.

      One of these approaches is to use the internet to deliver stress management programs. The
      internet has now been used for about 10 years to deliver a range of programs to patients.
      There are limitations to this approach as well. For instance, 40-60% of patients who will use
      an internet-based program will not benefit from it. These patients need more support or
      guidance to get the most out of their internet-based program. This is the problem addressed
      using the proposed innovative trial design. Investigators aim to improve the number of
      patients with CVD who improve after receiving a stress management program by changing the
      type and level of support they receive over time. This type of innovative trial design is
      more and more popular, but has never been used to enhance a stress management programs for
      patients with CVD.
BACKGROUND: Stress has a negative impact on the experience of individuals with a
      cardiovascular disease-both directly (e.g., physiologic effects of stress may worsen
      cardiovascular disease) and indirectly (e.g., leads to higher perceived symptom severity).
      Therefore, stress management has become an extensively researched form of psychological
      therapy for these individuals, and is increasingly offered through the internet. Advantages
      of internet-based interventions include being time efficient (e.g., cut travel time),
      reducing waiting-lists, and increasing access for some sub-groups of the population (e.g.,
      those living in rural and remote areas). Internet-based interventions also have the potential
      to integrate effective features of face-to-face interventions (e.g., tailored feedback,
      monitoring), but offer the scalability needed for public health interventions. However, up to
      60% of individuals do not respond to these interventions, and for these individuals offering
      different types of support or increasing the intensity of the support provided is necessary.
      An innovative trial design to develop time-varying, adaptive interventions to maximize
      clinical effectiveness is the Sequential multiple assignment randomized trials (SMARTs).
      However, despite increasing popularity, SMARTs remain relatively new to intervention
      researchers.

      GOAL AND OBJECTIVES: The goal of this pilot Sequential Multiple Assignment Randomized Trial
      (SMART) is to inform the planning of a subsequent larger SMART to evaluate an adaptive
      internet-based stress management program that follows a stepped-care model for adults with a
      cardiovascular disease. The primary objectives are to examine the (a) feasibility of the
      SMART procedures and different combinations of the stress management program (recruitment,
      retention, and questionnaire completion rates, reach, and fidelity) and (b) acceptability of
      the combinations of the stress management program, including adapting the program for
      non-responders and assessing adherence, satisfaction, and stress management strategies
      learned. The secondary objective is to estimate the program's effect size to inform sample
      size calculations for a full-scale SMART.

      METHODOLOGY: 56 patients with a physician confirmed diagnosis of a cardiovascular disease
      will be recruited through clinic referrals and community-based study advertisement. Inclusion
      criteria are: (a) moderate stress (stress subscale score of 15 or more on Depression,
      Anxiety, and Stress Scale), (b) at least 18 years of age, (c) not participated in a stress
      management intervention in the past year, (e) regular access to a computer with internet and
      e-mail capabilities, and (f) reports understanding English or French. Eligibility will be
      confirmed mainly by self-report at the time of a screening interview. After completing their
      consent form and baseline questionnaire (T0), participants will be randomized to either: (a)
      a 6-week self-directed, web-based stress management program or (b) the same program plus
      weekly lay coaching. At the end of 6 weeks, intervention response will be assessed (T1
      questionnaire), and non-responders will include those who have a stress score that did not
      improve (i.e., less than 50% decrease) or have a stress score above the cut-off point for
      mild stress (primary tailoring variable). In both groups, non-responders will then be
      randomized a second time to either (a) continue with their first stage program or (b)
      professionally-led motivational interviewing for another 6 weeks. During this time,
      responders will continue their first stage programs. The internet-based stress management
      program is available through my Health CheckUp. All participants will then complete their
      12-13 weeks follow-up questionnaire (T2) to examine changes in stress and quality of life
      (primary outcomes), anxiety, depression, illness appraisal, self-efficacy, physical activity,
      and coping (secondary outcomes). Acceptability will be assessed by the satisfaction measure
      included in the follow-up questionnaire and further explored during an exit interview with
      participants. Feasibility measures will focus on the characteristics of the participants
      reached, protocol fidelity, percent of missing data, and recruitment and retention rates.

      SIGNIFICANCE: The potential reach of internet-based interventions promises considerable
      public health impact. However, to maximize impact, the most effective interventions need to
      be developed and adapted to patients' evolving needs. This study will use the innovative
      SMART design to evaluate an adaptive internet-based intervention for individuals with a
      physical chronic illness.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Feasibility
time frame: Recruitment over 6 months, participant follow-up over 13 weeks
description: defined as the practicality of implementing the SMART procedures and of offering different types and levels of support in conjunction with an Internet-based stress management program. Feasibility measures include fidelity, reach, recruitment rate, and questionnaire completion rates.
measure: Acceptability
time frame: Recruitment over 6 months, participant follow-up over 13 weeks
description: defined as patients' views of the programs, and will include satisfaction with the different types of support offered, appropriateness of adapting the programs for non-responders, examining attrition, and assessing adherence and skills learned.
measure: Clinical significance
time frame: At T2: 12-13 weeks
description: clinical significance of adapting the type and level of support provided on the primary and secondary outcomes of interest.
measure: Stress
time frame: At T0 (Baseline), T1 (6 weeks) and T2 (12-13 weeks)
description: Measured with the Depression, Anxiety, and Stress Scale
measure: Quality of life
time frame: At T0 (Baseline), T1 (6 weeks) and T2 (12-13 weeks)
description: Measured with the SF-12
arm group label: First stage: Self-directed My Health CheckUp
arm group type: Experimental
description: Participants randomized to this group will be sent an e-mail invitation by the research team to register to the website. Once registered, participants will receive a second e-mail that will provide brief instructions on getting started and invite them to use the website for 12 weeks ad libitum. No additional contact will be provided thereafter by research team.
arm group label: First stage: Minimally guided My Health CheckUp.
arm group type: Experimental
description: This group will also be invited to use the 12-week Internet-based stress management program, but they will additionally receive support via weekly telephone calls from a lay coach.
arm group label: Second stage: High intensity Motivational Interviewing (MI)
arm group type: Experimental
description: After 6 weeks, response to the first stage programs will be assessed and only the non-responders will be randomized a second time to (a) continue with the first stage programs or (b) High-intensity MI. In addition to continued access to My Health CheckUp, participants in this group will also be supported with 6 weekly, telephone-based MI sessions.
intervention type: Behavioral
intervention name: My Health CheckUp Online Stress Management Program
description: Self-contained, web-based, stress management program developed by team of health care professionals, designed to encourage patients to learn evidence-based cognitive and behavioural strategies to effectively manage stress. Health risk appraisals include evidence-based recommendations to address risks. Stress management modules include education about the impact of stress, self-monitoring through a stress diary, and using four key strategies: physical activity, deep breathing and relaxation, problem-solving/addressing negative thoughts, and sleep hygiene. Through the modules, patients will learn new stress management strategies and have an opportunity to practice these, track their progress, and obtain feedback via the website. To facilitate self-monitoring of stress levels and tracking of strategies such as physical activity, tracking tools can be used on mobile devices.
arm group label: First stage: Minimally guided My Health CheckUp.
arm group label: First stage: Self-directed My Health CheckUp
arm group label: Second stage: High intensity Motivational Interviewing (MI)
intervention type: Behavioral
intervention name: Lay telephone coaching
description: The goal of telephone coaching will be to provide brief encouragement on how to use the modules; however, no formal therapy will be provided. Sessions will range between 10-15 minutes. Each coach session will follow the process outlined by the GROW model, which stands for Goal, Reality, Options/Obstacles, and Will/Way forward. The sessions will start with the coach and participant agreeing on the topics for discussion and desired outcomes (goal). Then, coaches will explore the use of the intervention over the previous week, guide participants through the modules, identify barriers to using these modules, offer advice to overcome these barriers, and provide positive reinforcement. The development of an action plan for the following week will conclude each session. The short Perceived Stress Scale will be used at the end of each session to monitor progress. A script will guide the lay coach through each call.
arm group label: First stage: Minimally guided My Health CheckUp.
intervention type: Behavioral
intervention name: Motivational interviewing (telephone)
description: Sessions will range from 30 to 45 minutes. The goal of MI is to strengthen patients' motivation and confidence for adopting the stress management strategies suggested. The MI practitioner's interventions are based on the four processes of MI: Engaging, Focusing, Evoking, and Planning.
arm group label: Second stage: High intensity Motivational Interviewing (MI)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sylvie D Lambert, PhD
role: Principal Investigator
affiliation: McGill University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McGill University
investigator full name: Sylvie Lambert
investigator title: Assistant professor
mesh term: Cardiovascular Diseases
mesh term: Stress, Psychological
sharing ipd: No