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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03267953
• Other study ID #: SMHC 17 11
• Status: Completed
• Phase: N/A
• Start date: October 30, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: November 2019
• Source: St. Mary's Research Center, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: August 31, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Stress, Psychological

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Canada	St Mary's Hospital Centre	Montréal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
St. Mary's Research Center, Canada	McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stress	Measured with the Depression, Anxiety, and Stress Scale	At T0 (Baseline), T1 (6 weeks) and T2 (12-13 weeks)
Other	Quality of life	Measured with the SF-12	At T0 (Baseline), T1 (6 weeks) and T2 (12-13 weeks)
Primary	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
Primary	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	Clinical significance	clinical significance of adapting the type and level of support provided on the primary and secondary outcomes of interest.	At T2: 12-13 weeks