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

NCT07706816 | Not Yet Recruiting

• 1 other identifier: BRIM-55_Feasibility
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (7)

• 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%.

  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%.

  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%

  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%.

  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

  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.

  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.

  From the end of the intervention to two weeks later.

Other Outcomes (7)

• Cardiac distress

  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

  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

  From the end of the intervention to two weeks later.

Study Arms (1)

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.

Behavioral: Remote-delivery Balance in Everyday Life (rBEL) Program for Myocardial Infarction Patients Younger Than 55 Years With Cardiac Distress

Interventions

Remote-delivery Balance in Everyday Life (rBEL) Program for Myocardial Infarction Patients Younger Than 55 Years With Cardiac Distress BEHAVIORAL

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.

Remote-delivery Balance in Everyday Life (rBEL) intervention group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Uppsala University

Uppsala, 752 37, Sweden

Location

MeSH Terms

Conditions

Heart Diseases; Depression; Myocardial Infarction; Anxiety Disorders

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Behavioral Symptoms; Behavior; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Mental Disorders

Study Officials

• Erik Olsson MG Olsson, Professor

  Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erik MG Olsson, Professor

CONTACT

+46729999210; erik.mg.olsson@uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Feasibility study

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 16, 2026
• Study Start (Estimated): August 24, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)