Remote-delivered Mindfulness-Based Cognitive Therapy to Target Fear of Recurrence Among SCAD Survivors
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Feasibility of Enrollment: Percent of Participants Enrolled
研究概览
简要总结
Spontaneous coronary artery dissection (SCAD) is an important cause of cardiac events, primarily affecting young healthy women with no cardiovascular risk factors. The 10-year recurrence rate is 30%, but SCAD recurrence cannot be predicted. Approximately half of SCAD survivors struggle with significant anxiety and fear of recurrence (FOR), which contributes to poor sleep and physical inactivity and, thereby, increased risk of recurrence. Mindfulness-Based Cognitive Therapy (MBCT) is an 8-week group intervention with evidence to improve FOR and health behaviors (sleep, physical activity), through psychological mechanisms that directly target key FOR processes (interoceptive bias, intolerance of uncertainty). I adapted MBCT to target FOR, sleep, and physical activity in cardiac event survivors via group videoconferencing delivery (UpBeat-MBCT), however this intervention has not yet been targeted to SCAD survivors. I propose an open pilot trial to test the feasibility, acceptability, and changes in psychological and behavioral health variables in SCAD survivors participating in UpBeat-MBCT (N=16). Participants will be recruited from the MGH SCAD Program and asked to complete self-report surveys and actigraphy before and after the intervention. The primary outcomes are feasibility and acceptability of the intervention and research procedures. Exploratory outcomes are changes in psychological and behavioral variables and their inter-correlations. This project would be the first and only behavioral intervention for SCAD survivors and would provide preliminary data for an NIH Stage II efficacy trial to develop an accessible and efficacious intervention for a vulnerable group of SCAD survivors, with generalizability to survivors of other cardiac events.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Cardiologist-confirmed diagnosis of SCAD in the past 1-12 months
- •English-speaking and reading
- •Internet access (via computer or mobile device).
排除标准
- •Terminal illness with life expectancy <1 year
- •Severe mental illness requiring urgent psychiatric intervention (e.g., active suicidal ideation) or past-year psychiatric hospitalization)
- •Significant cognitive impairment preventing informed consent determined by study staff or medical record review (e.g., medical history of cognitive impairment)
- •Deemed unable to complete research procedures (e.g., group sessions or surveys) per clinical judgment of study staff
- •Unavailable for intervention sessions (e.g., schedule conflicts)
结局指标
主要结局
Feasibility of Enrollment: Percent of Participants Enrolled
时间窗: 7 months
Feasibility will be assessed by \>70% of eligible patients enroll
Feasibility of Videoconferencing Delivery: Percent of Sessions With Videoconferencing Problems
时间窗: 7 months
Feasibility of videoconferencing delivery will be assessed by \<20% of sessions missed due to videoconference problems
Intervention Acceptability: Plans to Use the Skills in the Future
时间窗: 7 months
Intervention acceptability will be assessed by \>70% plan to use the intervention skills in the future
Feasibility of MBCT Intervention: Participant Attendance Rates
时间窗: 7 months
Feasibility of UpBeat-MBCT intervention will be assessed by \>70% of participants attending \>6/8 sessions
Intervention Acceptability: Would Recommend the Program to Others
时间窗: 7 months
Intervention acceptability will be assessed by \>70% would recommend the program to others
Acceptability of Daily Diary Surveys: Level of Survey Interference
时间窗: 7 months
Acceptability of daily diaries will be assessed by level of survey interference in daily life (1=not at all, 10=extremely, M\<2.0)
Acceptability of Actigraphy
时间窗: 7 months
Acceptability of actigraphy will be assessed by ratings of ease of actigraphy completion (1=not at all, 10 =extremely, M\>7.0)
Feasibility of Actigraphy Use: Percent of Participants Who Adhere to Actigraphy Procedures at Post-intervention
时间窗: 7 months
Feasibility of actigraphy use will be assessed by \>70% of participants completing actigraphy for 7 consecutive days at post-intervention
Feasibility of Retention: Percent of Enrolled Participants Retained at Post-intervention
时间窗: 7 months
Feasibility of retention will be assessed by \> 70% of participants completing the post-intervention survey
Feasibility of Daily Diaries: Percent of Participants Who Complete the Daily Diaries at Pre-intervention
时间窗: 7 months
Feasibility of daily diary completion will be assessed by \>70% of participants completing daily diaries for 7 consecutive days at pre-intervention
Feasibility of Daily Diaries: Percent of Participants Who Complete the Daily Diaries at Post-intervention
时间窗: 7 months
Feasibility of daily diary completion will be assessed by \>70% of participants completing daily diaries for 7 consecutive days at post-intervention
Feasibility of Actigraphy Use: Percent of Participants Who Adhere to Actigraphy Procedures at Pre-intervention
时间窗: 7 months
Feasibility of actigraphy use will be assessed by \>70% of participants completing actigraphy for 7 consecutive days at pre-intervention
Intervention Acceptability: Home Practice Completion
时间窗: 7 months
Acceptability of the UpBeat-MBCT intervention will be assessed by \>70% of participants completing home practice \>3days/week
Acceptability of Daily Diary Surveys: Ease of Completion
时间窗: 7 months
Acceptability of daily diaries will be assessed by ease of daily diary completion (1=not at all, 10=extremely). Mean acceptability rating \> 7.0 indicates acceptability
次要结局
- Fear of Recurrence(7 months)
- Self-reported Sleep Outcomes(3 months)
- Distress Tolerance(7 months)
- Cardiac Anxiety(7 months)
- Non-judgmental Body Awareness(7 Months)
- Cognitive De-centering(7 months)
- Attention Regulation(7 months)
- Interoceptive Bias(7 months)
- Intolerance of Uncertainty(7 months)
- Self-reported Physical Activity(3 months)
研究者
Christina Luberto
Assistant Professor of Psychology
Massachusetts General Hospital