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Adaptive Internet-based Stress Management Among Adults With a Cardiovascular Disease: A Pilot Sequential Multiple Assignment Randomized Trial (SMART) Design

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ClinicalTrials.gov Identifier: NCT03267953
Recruitment Status : Recruiting
First Posted : August 31, 2017
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
McGill University
Information provided by (Responsible Party):
Sylvie Lambert, McGill University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Stress, Psychological Behavioral: My Health CheckUp Online Stress Management Program Behavioral: Lay telephone coaching Behavioral: Motivational interviewing (telephone) Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: Adaptive Internet-based Stress Management Among Adults With a Cardiovascular Disease: A Pilot Sequential Multiple Assignment Randomized Trial (SMART) Design
Actual Study Start Date : October 30, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: First stage: Self-directed My Health CheckUp
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.
Behavioral: My Health CheckUp Online Stress Management Program
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.

Experimental: First stage: Minimally guided My Health CheckUp.
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.
Behavioral: My Health CheckUp Online Stress Management Program
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.

Behavioral: Lay telephone coaching
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.

Experimental: Second stage: High intensity Motivational Interviewing (MI)
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.
Behavioral: My Health CheckUp Online Stress Management Program
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.

Behavioral: Motivational interviewing (telephone)
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.




Primary Outcome Measures :
  1. Feasibility [ Time Frame: Recruitment over 6 months, participant follow-up over 13 weeks ]
    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.

  2. Acceptability [ Time Frame: Recruitment over 6 months, participant follow-up over 13 weeks ]
    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.


Secondary Outcome Measures :
  1. Clinical significance [ Time Frame: At T2: 12-13 weeks ]
    clinical significance of adapting the type and level of support provided on the primary and secondary outcomes of interest.


Other Outcome Measures:
  1. Stress [ Time Frame: At T0 (Baseline), T1 (6 weeks) and T2 (12-13 weeks) ]
    Measured with the Depression, Anxiety, and Stress Scale

  2. Quality of life [ Time Frame: At T0 (Baseline), T1 (6 weeks) and T2 (12-13 weeks) ]
    Measured with the SF-12



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • physician-confirmed diagnosis of a CVD (at least 3 months since most recent diagnosis)
  • moderate stress as indicated by a score of > 15 on the stress subscale of the Depression, Anxiety, and Stress Scale (DASS)
  • regular access to a computer with Internet and e-mail capabilities
  • understands English or French

Exclusion Criteria:

  • participated in a stress management program in the past year
  • hospitalized or living in a long-term care residence
  • moderate-severe cognitive impairment (Blessed Orientation-Memory-Concentration test score 10+)
  • severe stress (DASS stress score > 34)
  • suicidal intent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03267953


Contacts
Contact: Sylvie D Lambert, PhD 514 345 3511 ext 3074 sylvie.lambert@mcgill.ca

Locations
Canada, Quebec
St Mary's Hospital Centre Recruiting
Montréal, Quebec, Canada, H3T1M5
Contact: Cindy Ibberson    514 345 3511 ext 5593    cindy.ibberson@ssss.gouv.qc.ca   
Sponsors and Collaborators
St. Mary's Research Center, Canada
McGill University
Investigators
Principal Investigator: Sylvie D Lambert, PhD McGill University

Responsible Party: Sylvie Lambert, Assistant professor, McGill University
ClinicalTrials.gov Identifier: NCT03267953     History of Changes
Other Study ID Numbers: SMHC 17 11
First Posted: August 31, 2017    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sylvie Lambert, McGill University:
Stress management, e-Health, cardiovascular disease, adaptive design, lay coaching, motivational interviewing

Additional relevant MeSH terms:
Cardiovascular Diseases
Stress, Psychological
Behavioral Symptoms