An interventional study of Remote-delivery Balance in Everyday Life (rBEL) Program for Myocardial Infarction Patients Younger Than 55 Years With Cardiac Distress in Cardiac Disease, Depression and Quality of Life and Cardiac Distress, sponsored by Uppsala University. Recruiting at 1 site in Sweden. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Uppsala University · Not applicable, Interventional, and Treatment
Among 90 studies in Myocardial Infarction with a site in Sweden — 13 open to participants now, 22 under way, 4 of them phase 3. Myocardial Infarction · Sweden.
Among the 90 studies in Myocardial Infarction with a site in Sweden, this one is the 65th largest by planned enrollment of the 70 interventional ones that give a count, is one of 2 that started in 2026, is one of 23 with no phase, reaches primary completion later than 11 of the 21 other live ones, and was the 90th registered.
2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.
This study's planned enrollment of 30 is below the median of 150 across 1,314 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →13 of the 90 studies in Myocardial Infarction with a site in Sweden are open now, in 12 countries. Each count lists the studies.
Of the 255 Myocardial Infarction studies recruiting now, 172 (67%) set no upper age limit and 26 (10%) stop at 75 or younger; 16 take children under 18; 27 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · no healthy volunteers.
The full table on the hub →90 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 2 started in 2026.
Median enrollment 875 across the 70 interventional studies, 5,518 across the 20 observational. Of the 64 that completed or were terminated, 21 (33%) have results posted.
38 of 90 have an industry lead sponsor. The 10 most frequent:
Uppsala University is the lead sponsor of 390 studies on the registry; 86 are open to participants now.
Uppsala University has 9 studies filed under Myocardial Infarction — fewer than ten, so there is no comparison to draw.
6 of the studies in Myocardial Infarction with a site in Sweden that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04957719Phase 3Viatris Innovation GmbHSelatogrel Outcome Study in Suspected Acute Myocardial Infarction | 2027-07 |
| NCT05889416Skane University HospitalThe Perfect-CR Implementation Study | 2026-12 |
| NCT03620266Ole Frobert, MD, PhDEffects of Bilberry and Oat Intake After Type 2 Diabetes and/or MI | 2026-12-31 |
| NCT07706816Uppsala UniversityEvaluation of a Remote Behavioural Stress Recovery Intervention for Myocardial Infarction Patients Younger Than Fifty-five (BRIM-55): A Feasibility Study | 2027-01-31 |
| NCT06927739AbcentraFocused Orticumab Research for Treating Inflammation in Coronary Arteries | 2027-02-08 |
Among the 90 studies in Myocardial Infarction with a site in Sweden, from their registry updates:
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
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.
2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.
This study's planned enrollment of 30 is below the median of 150 across 1,314 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Uppsala University is the lead sponsor of 390 studies on the registry; 86 are open to participants now.
Compared within Myocardial Infarction, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Heart Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
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.
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%.
Time frame: 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%.
Time frame: 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%
Time frame: 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%.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: From the end of the intervention to two weeks later.
Cardiac distress
Cardiac Distress Inventory (CDI)
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.
Recovery Experience
The Recovery Experience Questionnaire (REQ) has a max score of 80 where a higher score means more recovery.
Time frame: 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
The HeartQoL instrument has a max score of 42 where a higher score means better quality of life.
Time frame: From the end of the intervention to two weeks later.
Depression
The Patient Health Questionnaire, 9 items (PHQ-9) has a max score of 27. A higher score means more depressed.
Time frame: From the end of the intervention to two weeks later.
Anxiety
The instrument General Anxiety Disorder, 7 items version (GAD-7) has a max score of 21. A higher score means more anxiety.
Time frame: From the end of the intervention to two weeks later.
Working ability
Work Ability Index has a max score of 49 where a higher score means better working ability.
Time frame: From the end of the intervention to two weeks later.
Healthcare costs
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.
Time frame: From the end of the intervention to two weeks later.
Plan to share: No — Due to the European data protection law, this will not be allowed without a special ethical approval.
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Jan 2027, 5 months after the start.
Of 321 non-industry interventional studies with no phase under Myocardial Infarction, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 58. This study's planned 5 months is below that.
Counting every sponsor, half of 354 studies reached it within 34 months; a quarter within 15 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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