Optimizing Mindfulness-Based Cognitive Therapy Maintenance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Client Satisfaction Scale (CSQ) scores
研究概览
简要总结
Mindfulness-Based Cognitive Therapy (MBCT) combines meditation practices from Mindfulness-Based Stress Reduction (MBSR) with cognitive behavioral therapy to improve mental health. Although there is evidence that MBCT provides a variety of mental health benefits, it is particularly designed to prevent depression relapse, which occurs in 80% of people with a history of two episodes of depression. MBCT reduces depression relapse rates by 30%, on average after an eight-week course, and has lower relapse rates than continuing antidepressant medication. However, it is unknown what should be done following the program to optimize its long-term benefit. The investigators plan to conduct a pilot study in preparation for larger-scale clinical trial to determine the most effective maintenance approaches once MBCT has ended. The investigators gathered stakeholder input from MBCT graduates and MBCT teachers to inform the development of maintenance programs for MBCT. From this the investigators formulated several components of a maintenance program for MBCT. This includes providing a booster course for people who have already completed the MBCT program. This will be delivered as a 4-week course, meeting weekly, followed by monthly sessions to help participants build self-efficacy and agency with regard to creating their own plan for relapse prevention. This booster course is adapted from a 12-week program developed by Dr. Willem Kuyken at the Oxford Centre for Mindfulness. The team is planning the following sessions: 1 Deepening mindfulness with a focus on interoceptive awareness. 2) Hedonic system: Appreciating the light within. This would focus on positive emotion. 3) Responding not reacting 4) Two themes: taking care of ourselves, taking care of others. Integrating lessons into daily life with regards to sleep, diet, healthy relationships, behavioral activation. The study will also provide monthly follow-up sessions. The current study is a pilot study aimed at refining the intervention, providing initial data on acceptability and feasibility, and preliminary use of outcome measures in the context of the proposed study design.
详细描述
The current study is a pilot study aimed at refining a maintenance program for MBCT program graduates. It will provide initial data on acceptability and feasibility, and preliminary use of outcome measures in the context of the proposed study design. The first study group aims to have 10 - 15 participants and will be single arm, with the aim of getting feedback to refine the intervention program. The second study group will aim to enroll between 15 and 30 participants, who will be randomized to receive the intervention program or to a wait-list control group (who will receive the 4-week course 4 months later).
Intervention program: The intervention program will have three components that research subjects will be asked to participate in:
Four-week course to strengthen and extend skills learned in 8-week MBCT course. This will consist of four 2-hour sessions, occurring weekly for four weeks. They will cover content that builds on the original 8-week course. These will be led by an experienced teacher trained in leading MBCT courses with a background in mental health. Sessions will be conducted on a video conferencing platform (Zoom). As part of the course, participants will be asked to develop their own depression relapse plan that describes actions they can take that will be helpful if they are becoming depressed.
Monthly 1.5 hour meeting sessions. These will be led by an experienced MBCT teacher and will consist of a group meditation practice, a check-in time, and discussion of a topic relevant to the MBSR course. The monthly sessions will continue for a minimum of 3 months after the end of the last four-week course. Participants from the different four-week courses will join the same monthly meeting sessions. The investigators anticipate that the 2nd four-week course will start about 4 months after the first course, so that participants in the first group will have about 7 monthly meeting sessions.
Monthly check-in survey. This will be a brief (5 - 10 minute) survey (using Qualtrics) with questions about mood (Patient-Reported Outcomes Measurement Information System {PROMIS} Depression and Positive Affect scales) and recent meditation practice. For participants with elevated depression scores, trained study staff will send an email with the participant's earlier depression relapse plan as a reminder, and set a time to check-in with the participant by phone or Zoom to see how they are doing. If indicated, staff can arrange a brief (15 minutes or less) check-in with the monthly session MBCT teacher to go over current steps to prevent depression relapse.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Previously completed MBCT program.
- •A main reason (per self-report) for taking MBCT was for depression
- •Have smartphone or other device for attending virtual classes
- •Ability to speak and read English
- •Lives in US
排除标准
- •Patient Health Questionnaire 8 (PHQ8) score >14 or 5+ items endorsed "more than half the days" or more, one of which corresponds to Question #1 or #2 (generally regarded as indicative of current Major Depressive Disorder).
- •High current risk of suicide on Columbia-Suicide Severity Rating Scale (CSSR-S) or history of attempt in past year
- •Unable or unwilling to attend Zoom group-based sessions as scheduled
- •History of Bipolar 1 disorder, Psychosis or Schizophrenia, or Borderline Personality disorder
- •Substance use, mental health, or other condition that in the opinion of the investigators will make participation in a group setting difficult.
结局指标
主要结局
Client Satisfaction Scale (CSQ) scores
时间窗: 4 months
Self-assessed satisfaction with care will be measured using the CSQ questionnaire. Scores on the 1979 version of the CSQ questionnaire range from 8 to 32, with higher scores indicating higher levels of satisfaction.
次要结局
- Client Satisfaction Scale (CSQ) scores(1 month)
- Change in Self-Compassion Scale-Short Form (SCS-sf) scores(Baseline to 4 months change)
- Change in Experiences Questionnaire scores(Baseline to 4 months change)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 8a scores(Baseline to 4 months change)
- Change in Five Facet Mindfulness Questionnaire-short form (FFMQ-sf) scores(Baseline to 4 months change)