Cardiac DiseaseBRIM-55NCT07706816
Evaluation of a Remote Behavioural Stress Recovery Intervention for Myocardial Infarction Patients Younger Than Fifty-five (BRIM-55): A Feasibility Study
A study testing Remote-delivery Balance in Everyday Life (rBEL) Program for Myocardial Infarction Patients Younger Than 55 Years With Cardiac Distress in people with Cardiac Disease and Depression and Quality of Life, run by Uppsala University at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cardiac Disease, Depression and Quality of Life, Cardiac Distress
- What is being tested?
- Remote-delivery Balance in Everyday Life (rBEL) Program for Myocardial Infarction Patients Younger Than 55 Years With Cardiac Distress
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 28 Aug 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Myocardial infarction (MI) before age 55 years
- MI within one year prior to randomization
- Report of subjective cardiac distress in the initial interview
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University
Uppsala, 752 37
Erik MG Olsson, Professor, +46729999210, erik.mg.olsson@uu.se
About this 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.
Read the 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
- How feasible is the study procedures of the planned evaluation study in terms of recruitment, retention and adherence rates?
- 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.
- Conditions
- Cardiac Disease, Depression and Quality of Life, Cardiac Distress, Myocardial Infarction, Psychological Distress, Anxiety
- Being tested
- Remote-delivery Balance in Everyday Life (rBEL) Program for Myocardial Infarction Patients Younger Than 55 Years With Cardiac Distress
- Keywords
- Cardiac distress, Heart Attack, Cognitive Behavioral Therapy, Secondary Prevention, Cardiac Rehabilitation, Stress Recovery, Behavioral Intervention
- Medical subject headings
- Heart Diseases, Depression, Myocardial Infarction, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote-delivery Balance in Everyday Life (rBEL) Program for Myocardial Infarction Patients Younger Than 55 Years With Cardiac DistressBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Remote-delivery Balance in Everyday Life (rBEL) intervention group | Experimental | 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. Receives: Behavioral: Remote-delivery Balance in Everyday Life (rBEL) Program for Myocardial Infarction Patients Younger Than 55 Years With Cardiac Distress |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Six weeks from when the invitation letter was sent out
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%.
Measured: Four weeks from the screening interview
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%
Measured: From start of intervention to 12 weeks later.
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%.
Measured: From the end of the intervention to two weeks later.
Adverse events
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
Measured: From intervention start to four weeks after intervention end.
Program credibility
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.
Measured: Rating is done after first intervention session (first week of intervention). A two week submission period is allowed.
Program satisfaction
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.
Measured: From the end of the intervention to two weeks later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start28 Aug 2026
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Olsson, Uppsala University
- Investigators
- Erik Olsson MG Olsson, Professor, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706816
- Sponsor's protocol ID
- BRIM-55_Feasibility
- Acronym
- BRIM-55
- Status last verified
- Oct 2026
- First submitted
- 2 Jul 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the European data protection law, this will not be allowed without a special ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Remote Behavioural Stress Recovery Intervention for Myocardial Infarction Patients Younger Than Fifty-five (BRIM-55): A Feasibility Study
- ClinicalTrials.gov ID
- NCT07706816
- Acronym / sponsor ID
- BRIM-55 / BRIM-55_Feasibility
- Conditions
- Cardiac Disease, Depression and Quality of Life, Cardiac Distress, Myocardial Infarction, Psychological Distress, Anxiety
- Keywords
- Cardiac distress, Heart Attack, Cognitive Behavioral Therapy, Secondary Prevention, Cardiac Rehabilitation, Stress Recovery, Behavioral Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 28 Aug 2026 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- How feasible is the study procedures of the planned evaluation study in terms of recruitment, retention and adherence rates?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study
| Arm | Type | Receives |
|---|---|---|
| Remote-delivery Balance in Everyday Life (rBEL) intervention group | Experimental | Behavioral: Remote-delivery Balance in Everyday Life (rBEL) Program for Myocardial Infarction Patients Younger Than 55 Years With Cardiac DistressParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Myocardial infarction (MI) before age 55 years
- MI within one year prior to randomization
- Report of subjective cardiac distress in the initial interview
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote-delivery Balance in Everyday Life (rBEL) Program for Myocardial Infarction Patients Younger Than 55 Years With Cardiac DistressThe 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. | Behavioural | Remote-delivery Balance in Everyday Life (rBEL) intervention group |
Primary outcome
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%.
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%.
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%
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%.
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
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No. Due to the European data protection law, this will not be allowed without a special ethical approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erik Olsson MG Olsson, Professor principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote-delivery Balance in Everyday Life (rBEL) Program for Myocardial Infarction Patients Younger Than 55 Years With Cardiac Distress in people with Cardiac Disease and Depression and Quality of Life, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erik MG Olsson, Professor (+46729999210, erik.mg.olsson@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: Six weeks from when the invitation letter was sent out). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.