Mindfulness-Based Cognitive Therapy Delivered Via Group Videoconferencing for Acute Coronary Syndrome Patients With Depressive Symptoms: A Pilot RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Recruitment Feasibility: Percent of Participants Screened Eligible
研究概览
简要总结
The aim of this study is to establish, in a pilot RCT (approx. N=50 participants) with a time- and attention-matched health enhancement control, (a) the feasibility of the recruitment procedures (screening, eligibility, enrollment rates), and feasibility and acceptability of the (b) MBCT and control interventions (adherence, retention, fidelity, satisfaction, group videoconferencing delivery) and (c) data collection procedures by group (adherence, satisfaction). Hypothesis 1a: Recruitment will be feasible as evidenced by screening, eligibility, and enrollment rates; (1b) the MBCT and control interventions and (1c) data collection procedures in both groups will be feasible and acceptable.
详细描述
The current study will employ an open pilot RCT with a time-and-attention-matched health control group to determine the feasibility and acceptability of a virtual, MBCT intervention for ACS patients. The investigators plan to enroll approximately N=50 participants (approx. 3 MBCT groups and approx. 3 health enhancement control groups with approximately 6-7 participants per group; accounting for 20% attrition). Participants will be randomized to a MBCT or a time- and attention-matched health enhancement control in a 1:1 design using a random number generator. Participants will then be stratified by antidepressant medication use. The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will be taught how to use evidence-based mindfulness skills to regulate distress and choose healthy behaviors, as well as learn about cardiac health. The health enhancement control group will follow the same structure of the MBCT intervention (e.g., 8 virtually-delivered MBCT sessions, approximately 1.5 hours each) and will educate participants on depression and cardiac health (e.g., relationship between depression and cardiac health, cardiac risk factors, cardiac health behaviors, finding resources for mental health care). Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30-60 minutes).
Participants will be recruited through EPIC, the hospital's clinical data registry, advertisements (e.g., flyers, brochures) placed throughout the hospital, direct provider referrals, and from inpatient cardiac units. Patients who express interest in the study will be asked complete an eligibility screening. Eligible patients agreeable with study participation will then complete informed consent with study staff prior to enrollment.
Participants will be enrolled in either one of three MBCT intervention cohorts (approx.) or one of three health enhancement control cohorts (approx.). Participants in all of these groups will be expected to participate in 8-weekly, 1.5-hour virtual sessions. Participants in the MBCT intervention group will be expected to participate in 30 minutes of at-home daily practice. Participants in the health enhancement control group will be expected to review educational videos or readings between sessions. A licensed mental health provider (e.g., LICSW, PhD) trained in the MBCT protocol will delivered the intervention to the MBCT intervention group. A licensed clinician or pre-doctoral or post-doctoral fellow with supervision from a licensed clinician will lead the control group. Both the MBCT intervention and health enhancement control groups will be delivered via Zoom, secure, HIPPA-compliant video-conferencing software.
Study assessments will include a battery of self-report surveys administered at baseline, post-intervention, and 3-month follow-up; session satisfaction surveys administered after each intervention session; post-intervention individual exit interviews (conducted via telephone or videoconference); blood spot samples self-collected by participants at baseline, post-intervention, and 3-month follow-up (submitted to the research team via paper mail); and, for the MBCT-intervention group, home practice logs submitted between each intervention session. Primary outcomes for the intervention are feasibility and acceptability. Exploratory outcomes are changes in emotional and biological variables. Data collected from this study will generate knowledge about e-health technologies and congruent research methods to apply to other mind-body interventions and patient populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lifetime ACS per medical record and/or patient confirmation
- •Current elevated depression symptoms (PHQ-9 greater than or equal to 5)
- •Age 35-85 years
- •Access to high-speed internet
排除标准
- •Active suicidal ideation or past-year psychiatric hospitalization (per patient report and/or medical record review)
- •Non-English-speaking
- •Cognitive impairments preventing informed consent per medical record review and/or cognitive Screen less than or equal to 4
- •Patient deemed unable to complete the study protocol or has a condition that would likely interfere with the study
结局指标
主要结局
Recruitment Feasibility: Percent of Participants Screened Eligible
时间窗: 6 months
Feasibility outcomes for recruitment will include: \>70% meet screening criteria
MBCT Feasibility: Percent of Participants Retained
时间窗: 6 months
MBCT intervention feasibility will include: \>75% of participants retained at post-assessment survey
Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Treatment
时间窗: 6 months
MBCT intervention feasibility will include: \>75% of participants attending 6/8 sessions. "Adherent to treatment" is defined as participants attending 6 out of 8 sessions.
Mindfulness Based Cognitive Therapy (MBCT) Feasibility: Percent of Participants Adherent to Home Practice
时间窗: 6 months
MBCT feasibility will include: \>75% complete home practice at least 3 days/week. Adherence was defined as completion of home practice long at least 3 days per week.
Recruitment Feasibility: Percent of Participants Enrolled
时间窗: 6 months
Feasibility outcomes for recruitment will include: \>70% of eligible enroll
Control Group Feasibility: Percent of Participants Retained
时间窗: 6 months
Control group feasibility will include: \>75% of participants retained at post-assessment survey
Control Group Feasibility: Percent of Participants Adherent to Treatment
时间窗: 6 months
Control group feasibility will include: \>75% of participants attending 6/8 sessions sessions. "Adherent to treatment" is defined as participants attending 6 out of 8 sessions.
Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Ratings of Intervention Satisfaction
时间窗: At post intervention (Month 3)
MBCT acceptability will be assessed by overall program satisfaction (1=not at all, 10=very much). Satisfaction will be measured by mean score greater than 7.5
Control Group Feasibility: Percent of Participants Adherent to Home Practice
时间窗: 6 months
Control group feasibility will include: \>75% complete home practice at least 3 days/week. "Adherent to home practice" is defined as participants completing home practice at least 3 days per week.
Videoconferencing Feasibility: Number of Sessions Missed Due to Technical Problems
时间窗: 6 months
Videoconferencing feasibility will be assessed by: \<20% of sessions missed due to technical problems
Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Baseline
时间窗: At Baseline (Month 0)
Blood spot feasibility will be assessed by \>75% of samples submitted at baseline. Participants contributed one blood spot sample at the specified time point.
Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Would Recommend the Program
时间窗: 6 months
MBCT and acceptability will be assessed by \>75% of participants reporting that they would recommend the program to others
Control Group Acceptability: Ratings of Intervention Satisfaction
时间窗: 6 months
Control group acceptability will be assessed by overall program satisfaction (1=not at all, 10=very much). Satisfaction will be measured by an overall mean score greater than 7.5.
Blood Spot Feasibility: Percent of Blood Spot Samples Submitted at Post-intervention
时间窗: At Post Intervention (Month 3)
Blood spot feasibility will be assessed by \>75% of samples submitted at post-intervention
Mindfulness Based Cognitive Therapy (MBCT) Acceptability: Percent of Participants Who Plan to Continue Using the Skills
时间窗: 6 months
MBCT and acceptability will be assessed by 75% plan to use the skills
Control Group Acceptability: Percent of Participants Who Plan to Continue Using the Skills
时间窗: 6 months
Control group acceptability will be assessed by 75% of participants reporting that they plan to use the skills
Control Group Acceptability: Percent of Participants Who Would Recommend the Program
时间窗: 6 months
Control group acceptability will be assessed by \>75% of participants reporting that they would recommend the program to others
Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction
时间窗: 6 months
Videoconferencing acceptability will be assessed in terms of overall satisfaction (1=poor,10=excellent; M\>7.5)
Blood Spot Acceptability: Blood Spot Collection Ease
时间窗: 6 months
Blood spot acceptability will be assessed by ratings of ease of data collection (1=not at all, 10=extremely). Satisfaction will be measured by an overall mean score greater than 7.5.
Blood Spot Acceptability: Blood Spot Collection Comfort
时间窗: 6 months
Blood spot acceptability will be assessed by ratings of ease of level of pain (1=very much pain, 10=very little pain; M\>8.0). Acceptability will be measured by an overall mean score greater than 8.0.
次要结局
未报告次要终点
研究者
Christina Luberto
Assistant Professor, Department of Psychiatry, Harvard Medical School; Staff Psychologist, Massachusetts General Hospital
Massachusetts General Hospital