Clinical trial NCT03267953: Adaptive Internet-based Stress Management Among Adults With a Cardiovascular Disease: A Pilot Sequential Multiple Assignment Randomized Trial (SMART) Design
Official title: Adaptive Internet-based Stress Management Among Adults With a Cardiovascular Disease: A Pilot Sequential Multiple Assignment Randomized Trial (SMART) Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Stress, Psychological
Keywords: Stress management, e-Health, cardiovascular disease, adaptive design, lay coaching, motivational interviewing
Lead sponsor: St. Mary's Research Center, Canada
Sponsor class: OTHER
Collaborators: name: McGill University
First posted: 2017-08-31
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Feasibility
timeFrame: Recruitment over 6 months, participant follow-up over 13 weeks
measure: Acceptability
timeFrame: Recruitment over 6 months, participant follow-up over 13 weeks
Secondary outcomes:
measure: Clinical significance
timeFrame: At T2: 12-13 weeks
Other outcomes:
measure: Stress
timeFrame: At T0 (Baseline), T1 (6 weeks) and T2 (12-13 weeks)
measure: Quality of life
timeFrame: At T0 (Baseline), T1 (6 weeks) and T2 (12-13 weeks)
Locations:
city: Montréal
country: Canada
facility: St Mary's Hospital Centre
state: Quebec
Study officials:
affiliation: McGill University
name: Sylvie D Lambert, PhD
role: PRINCIPAL_INVESTIGATOR
References: