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

NCT03267953 | Completed

• 1 other identifier: SMHC 17 11
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Stress, Psychological

Keywords

Stress management, e-Health, cardiovascular disease, adaptive design, lay coaching, motivational interviewing

Outcome Measures

Primary Outcomes (2)

• Feasibility

  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.

  Recruitment over 6 months, participant follow-up over 13 weeks

• Acceptability

  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.

  Recruitment over 6 months, participant follow-up over 13 weeks

Secondary Outcomes (1)

• Clinical significance

  At T2: 12-13 weeks

Other Outcomes (2)

• Stress

  At T0 (Baseline), T1 (6 weeks) and T2 (12-13 weeks)

• Quality of life

  At T0 (Baseline), T1 (6 weeks) and T2 (12-13 weeks)

Study Arms (3)

First stage: Self-directed My Health CheckUp

EXPERIMENTAL

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

First stage: Minimally guided My Health CheckUp.

EXPERIMENTAL

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; Behavioral: Lay telephone coaching

Second stage: High intensity Motivational Interviewing (MI)

EXPERIMENTAL

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; Behavioral: Motivational interviewing (telephone)

Interventions

My Health CheckUp Online Stress Management Program BEHAVIORAL

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.

First stage: Minimally guided My Health CheckUp.; First stage: Self-directed My Health CheckUp; Second stage: High intensity Motivational Interviewing (MI)

Lay telephone coaching BEHAVIORAL

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.

First stage: Minimally guided My Health CheckUp.

Motivational interviewing (telephone) BEHAVIORAL

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.

Second stage: High intensity Motivational Interviewing (MI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Mary's Research Center, Canada: lead
• McGill University: collaborator

Study Sites (1)

St Mary's Hospital Centre

Montreal, Quebec, H3T1M5, Canada

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Stress, Psychological

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Sylvie D Lambert, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: August 31, 2017
• Study Start: October 30, 2017
• Primary Completion: February 28, 2019
• Study Completion: August 31, 2019
• Last Updated: November 4, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)