Evaluation of a Remote Behavioural Stress Recovery Intervention for Myocardial Infarction Patients Younger Than Fifty-five (BRIM-55): A Feasibility Study

Evaluation of a Remote Behavioural Stress Recovery Intervention for Myocardial Infarction Patients Younger Than Fifty-five (BRIM-55): A Feasibility Study

The goal of this feasibility study is to learn if the randomised controlled trial evaluating the Remote-delivery Balance in Everyday Life (rBEL) programme for adults younger than 55 years who have experienced a myocardial infarction (MI), is feasible.

The objective is to examine the feasibility of the rBEL programme and the associated study procedures before a controlled evaluation of the programme. This is an uncontrolled, single-arm, pre-post treatment designed study.

Participants of the target population will take part of the six session over 13 week programme. Feasibility will be evaluated against predefined feasibility criteria regarding study procedures and programme acceptability.

BACKGROUND Even though there have been major improvements in medical treatments resulting in considerably lower mortality rates, cardiovascular diseases (CVDs) remain the leading cause of death and the main cause of loss of disability-adjusted life-years worldwide. Myocardial infarction (MI) is the most common of the serious CVDs. While the total number of MIs has decreased during the last decades, the proportion of young patients hospitalized with MI has increased.

Cardiac distress (CD) summaries the psychological impacts of a cardiac event and expands on the general "psychological distress" concept (i.e. symptoms of depression and anxiety). Cardiac distress is common after an MI. For young persons, having an MI is particularly stressful and the prevalence of anxiety and depression is more than double compared to that of older patients.

Conventional stress management intervention programs are based on a "reactivity paradigm", with techniques used to reduce, avoid, or change the interpretation of the stressors and/or stress responses associated with distress. An alternative, contrasting strategy is to address recovery processes. To the best of our knowledge, the intervention program Balance in Everyday Life (BEL), based on cognitive behavioural principles, has the best empirical support.

Guidelines for cardiac rehabilitation recommend screening of psychosocial aspects but interventions in this area are very rare in clinical practice.

METHOD Aim The aims are to assess feasibility and acceptability of the iBEL program for post-myocardial infarction survivors aged below 55 years reported ongoing CD, and the study procedures of the later evaluation study.

Research Questions

1. How feasible is the study procedures of the planned evaluation study in terms of recruitment, retention and adherence rates?
2. To what extent is the iBEL program perceived as acceptable to young post-MI survivors, in terms of its content, delivery method and relevancy?

Design An uncontrolled, single-arm, pre-post treatment design.

Participants Thirty participants of the target population will be included. Exclusion criteria: (i) not being able to read, write or speak Swedish, (ii) being able to use the digital device necessary for participation and (iii) early retirement or disability pension at the time of the MI.

Procedure Participants will be recruited via a register extraction from SWEDEHEART of all persons having an MI before the age of 55 one year before intervention start. Preliminary eligible participants will be sent an invitation letter primarily via a digital post-box with a description of the study and an option to register interest for the study. To qualify as participants with CD, they must state they have at least experienced moderate distress as a consequence of their MI which impairs day-to-day recovery, and they believe psychological support will benefit them. They are then asked to provide written consent.

The Program The program consists of 6 sessions spread out over 13 weeks. Each session includes a video-call meeting online, via the platform Zoom, with a therapist. The therapists are healthcare workers (clinical social workers-LCSW, MSW specialized in psychotherapy, nurses psychiatric/mental health nurse practitioners- PMHNPs, occupational therapists with mental health specialization) with training in clinical conversations or students recruited from the final semesters of the university programs for psychologists or physiotherapists with basic training in clinical conversations. They will be trained in the rBEL program and receive supervision by a senior therapist. Before each data collection time-point, participants will be prompted and, if necessary, reminded to report via SMS and/or e-mail, based on their preference, and thereafter, if needed, via telephone.

In addition to this meeting with the therapist there is psychoeducational material on a website (www.brim55.se) and a printed booklet for exercise notations.

Data analysis The feasibility results will be evaluated against pre-specified progression criteria. The sample size (N=30) is based on a rule-of-thumb for feasibility studies and is judged to be enough for detecting feasibility concerns.

Inclusion criteria:

• Myocardial infarction (MI) before age 55 years
• MI within one year prior to randomization
• Report of subjective cardiac distress in the initial interview

Exclusion criteria:

• Serious conditions hindering participation (e.g., active substance misuse, severe mental illness)
• Insufficient Swedish proficiency for study procedures,
• Disability pension or early retirement at the time of MI