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.
Myocardial infarction (MI) before age 55 years
MI within one year prior to randomization
Report of subjective cardiac distress in the initial interview
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
Single group
Remote-delivery Balance in Everyday Life (rBEL) Program for Myocardial Infarction Patients Younger Than 55 Years With Cardiac Distress
BehavioralThe Remote-delivery Balance in Everyday Life (rBEL) program is a 13-week therapist-supported behavioral stress recovery intervention for adults younger than 55 years who have experienced a myocardial infarction and report cardiac distress. The program includes six individual online sessions delivered by a therapist, a printed exercise workbook, and online video materials. The content focuses on recovery behaviors, relaxation training, self-monitoring, use of recovery strategies in daily life and work settings, and management of heart-related worry and anxiety.
Recruitment
The pre-specified progression criteria are formulated as Green=Go ahead, Yellow=Amend, Red=Revise. Green: ≥8% of the invited population starting intervention. Yellow: \<8% and ≥6%. Red: \<6%.
Acceptability
The pre-specified progression criteria are formulated as Green=Go ahead, Yellow=Amend, Red=Revise. Green: ≥75% of eligible participants consent. Yellow: \<75% and ≥60%. Red: \<60%.
Participant adherence
The pre-specified progression criteria are formulated as Green=Go ahead, Yellow=Amend, Red=Revise. Green: ≥70% of the participants completing a minimum of 4 sessions with the therapist. Yellow:\<70% and ≥60%. Red: \<60%
Retention
The pre-specified progression criteria are formulated as Green=Go ahead, Yellow=Amend, Red=Revise. Green: ≥90% complete data on the CDI, post-treatment. Yellow: \<90% and ≥75%. Red: \<75%.
Cardiac distress
Cardiac Distress Inventory (CDI)
Recovery Experience
The Recovery Experience Questionnaire (REQ) has a max score of 80 where a higher score means more recovery.
Health-related quality of life
The HeartQoL instrument has a max score of 42 where a higher score means better quality of life.
Depression
The Patient Health Questionnaire, 9 items (PHQ-9) has a max score of 27. A higher score means more depressed.
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