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

July 15, 2026 updated by: Erik Olsson, Uppsala University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Uppsala, Sweden, 752 37
        • Uppsala University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remote-delivery Balance in Everyday Life (rBEL) intervention group
Participants randomized to this arm will receive the Remote-delivery Balance in Everyday Life (rBEL) program, a therapist-supported behavioral stress recovery intervention delivered over 12 weeks. The program includes six individual online sessions, a printed workbook containing exercises and self-monitoring materials, and access to online video resources. The intervention is designed to promote recovery behaviors, improve stress regulation, and reduce cardiac distress following myocardial infarction.
Behavioral: Remote-delivery Balance in Everyday Life (rBEL) Program for Myocardial Infarction Patients Younger Than 55 Years With Cardiac Distress
The 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment
Time Frame: Six weeks from when the invitation letter was sent out

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%.
Six weeks from when the invitation letter was sent out
Acceptability
Time Frame: Four weeks from the screening interview

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%.
Four weeks from the screening interview
Participant adherence
Time Frame: From start of intervention to 12 weeks later.

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%
From start of intervention to 12 weeks later.
Retention
Time Frame: From the end of the intervention to two weeks later.

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%.
From the end of the intervention to two weeks later.
Adverse events
Time Frame: From intervention start to four weeks after intervention end.

The pre-specified progression criteria are formulated as Green=Go ahead, Yellow=Amend, Red=Revise.

Green: no inconveniences or adverse events linked to study participation reported.

Yellow: ≤ 2 reports of inconveniences (comparable to max 2 days of increased fatigue, stress or worry).

Red: any adverse event or more than 3 inconveniences reported linked to study participation
From intervention start to four weeks after intervention end.
Program credibility
Time Frame: Rating is done after first intervention session (first week of intervention). A two week submission period is allowed.

The pre-specified progression criteria are formulated as Green=Go ahead, Yellow=Amend, Red=Revise. The credibility subscale of the Credibility and Expectancy Questionnaire has a max score of 27. A higher score means more credibility.

Green: ≥75% of participants rate the credibility subscale of CEQ ≥ 7. Yellow: ≥75% rate it < 7 and ≥ 5. Red: >25% rate it < 5.
Rating is done after first intervention session (first week of intervention). A two week submission period is allowed.
Program satisfaction
Time Frame: From the end of the intervention to two weeks later.

The pre-specified progression criteria are formulated as Green=Go ahead, Yellow=Amend, Red=Revise. The Client Satisfaction Questionnaire 8 items version (CSQ-8) has a max score of 32 where a higher score means more satisfaction.

Green: ≥ 75% of participants score ≥26 on the CSQ-8. Yellow: ≥ 75% rate it ≥24. Red: > 25% rate it <24.
From the end of the intervention to two weeks later.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac distress
Time Frame: Mid intervention (CDI short form): After session 3 (2 week submission period) After intervention: From the end of the intervention to two weeks later.
Cardiac Distress Inventory (CDI)
Mid intervention (CDI short form): After session 3 (2 week submission period) After intervention: From the end of the intervention to two weeks later.
Recovery Experience
Time Frame: Mid intervention: After session 3 (2 week submission time frame). After intervention: From the end of the intervention to two weeks later.
The Recovery Experience Questionnaire (REQ) has a max score of 80 where a higher score means more recovery.
Mid intervention: After session 3 (2 week submission time frame). After intervention: From the end of the intervention to two weeks later.
Health-related quality of life
Time Frame: From the end of the intervention to two weeks later.
The HeartQoL instrument has a max score of 42 where a higher score means better quality of life.
From the end of the intervention to two weeks later.
Depression
Time Frame: From the end of the intervention to two weeks later.
The Patient Health Questionnaire, 9 items (PHQ-9) has a max score of 27. A higher score means more depressed.
From the end of the intervention to two weeks later.
Anxiety
Time Frame: From the end of the intervention to two weeks later.
The instrument General Anxiety Disorder, 7 items version (GAD-7) has a max score of 21. A higher score means more anxiety.
From the end of the intervention to two weeks later.
Working ability
Time Frame: From the end of the intervention to two weeks later.
Work Ability Index has a max score of 49 where a higher score means better working ability.
From the end of the intervention to two weeks later.
Healthcare costs
Time Frame: From the end of the intervention to two weeks later.
The instrument Treatment Inventory of Costs in Patients with psychiatric disorders, Midi version (TIC-P Midi) counts visits in health care. The more visits the higher the costs. Visits to specialists and hospital stays means higher costs than outpatient visits.
From the end of the intervention to two weeks later.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Erik Olsson MG Olsson, Professor, Uppsala University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 24, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

July 2, 2026

First Submitted That Met QC Criteria

July 15, 2026

First Posted (Actual)

July 16, 2026

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 15, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRIM-55_Feasibility

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to the European data protection law, this will not be allowed without a special ethical approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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