Evaluation of a Remote Behavioural Stress Recovery Intervention for Myocardial Infarction Patients Younger Than Fifty-five (BRIM-55): A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Myocardial infarction (MI) before age 55 years
- •MI within one year prior to randomization
- •Report of subjective cardiac distress in the initial interview
排除标准
- •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
结局指标
主要结局
Recruitment
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Erik Olsson
Professor
Uppsala University