Internet Mindfulness Meditation Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- Completion Rate
研究概览
简要总结
Phase 1 will follow 40 subjects and hopes to address whether or not IMMI can increase meditation practice as compared to another meditation program. The study will last six weeks for both the IMMI group (20 subjects) and the Access group (20 subjects). Access groups will receive learning materials and guided meditations, but the implementation will be self-paced. Participants in the IMMI group will receive weekly learning sessions and be required to practice meditation every day. IMMI group participants will also receive a weekly reminder call from a member of the study staff and have access to technical support in the event of trouble with the online program. All subjects will complete online self-report questionnaires that measure quality of life, self-efficacy, mood, sleep, mindfulness, and perceived stress at baseline and at the end of the six-week intervention. Subjects will also be given a questionnaire at the end of the study gauging their satisfaction with the mindfulness program they participated in.
Phase 2 will follow 80 subjects and hopes to address whether or not IMMI is acceptable to participants and demographic information about IMMI users. The study will be the same as noted above, but all subjects will be entered in the IMMI program.
Differences in recruitment rates, drop out, and patient satisfaction between the IMMI and Access groups will be analyzed. IMMI's ability to change meditation behavior (i.e. increasing time or frequency of meditation sessions), and improve quality of life will be examined as well.
详细描述
Participants will undergo the following: Week 0 - Telephone screening; Week 1 - Baseline Assessment; Week 2-Week 7 - Internet Mindfulness Meditation Intervention (or Access in Phase 1); Week 8 - Endpoint Assessment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 - 80 years old
- •Access to Computer and Internet
- •Can hear and understand instructions
- •Willing to accept randomization scheme and agrees to follow the study protocol
排除标准
- •Significant acute medical illness that would decrease likelihood of study completion (self-report)
- •Significant, untreated depression, as assessed by CESD-5 >20 during screening
- •Current daily meditation practice (≥ 5 min/day daily for at least 30 days in the last 6 months. Past practice not exclusionary but will be recorded)
研究组 & 干预措施
Internet Mindfulness Meditation Intervention
Six-week internet mindfulness meditation training program including handouts and daily guided meditations
干预措施: Internet Mindfulness Meditation (Behavioral)
Access
Written information handouts on mindfulness meditation and access to guided daily meditations
干预措施: Access (Behavioral)
结局指标
主要结局
Completion Rate
时间窗: Week 8 - Endpoint assessment
Number of participants who complete the endpoint assessment.
Enrollment rate
时间窗: Week 0 - Screening
Number of participants who are eligible and enroll in the study
Participant satisfaction
时间窗: Week 8 - Endpoint assessment
Client Satisfaction Questionnaire
Number of internet mindfulness meditation training sessions completed
时间窗: Week 8 - Endpoint Assessment (after intervention is complete)
There are a total of 6 internet training sessions, and participants are instructed to complete one per week (where Week 0 is screening, Week 1 is Baseline Assessment, Week 2 is Training 1, Week 3 is Training 2, Week 4 is Training 3, Week 5 is Training 4, Week 6 is Training 5, and Week 7 is Training 6) . At the time of the endpoint assessment (Week 8), the number of completed training sessions is tabulated.
次要结局
- Quality of Life SF-36(Week 1 - Baseline assessment & Week 8 - Endpoint assessment)
- Mood(Week 1 - Baseline assessment & Week 8 - Endpoint assessment)
- Sleep(Week 1 - Baseline assessment & Week 8 - Endpoint assessment)
- Mindfulness(Week 1 - Baseline assessment & Week 8 - Endpoint assessment)
- Self-efficacy(Week 1 - Baseline assessment & Week 8 - Endpoint assessment)
- Perceived Stress(Week 1 - Baseline assessment & Week 8 - Endpoint assessment)
研究者
Helane Wahbeh
ND, MCR
Oregon Health and Science University