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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Recruitment — 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 — 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 — 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 — 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 — 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 — 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 — 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.

Trial sites (1)

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