Tele-Mindfulness for Dementia's Family Caregivers: a Randomized Trial With a Usual Care Control Group
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 主要终点
- Perceived Stress Scale (PSS)- 10-item version
研究概览
简要总结
Family caregivers were recruited through a combinations of strategies including a larger caregiving project and its partners, memory clinics, community outreach, online advertisement, flyers and brochures and word of mouth. After the telephone screening, eligible individuals were scheduled for an in-person baseline meeting at which they received additional information about the study, signed a consent form, completed baseline outcome measures and then were randomized to the intervention or control group using an online randomization program (http://www.graphpad.com/quickcalcs/index.cfm). All participants completed outcome measures immediately post-intervention for the intervention group and at 2 months for the control group and all participants completed follow-up outcome measures at 3 month following the baseline assessment. Participants in the intervention group completed a practice log which was designed to track their daily practice of mindfulness at home. The study was reviewed and approved by the Mount Sinai Hospital Research Ethics Board.
详细描述
Intervention (tele-MBCT) group Tele-MBCT was an 8-week program delivered to participants online via a videoconferencing program called Zoom. Zoom is an Ontario Personal Health Information Act (PHIPA) compliant videoconferencing program that provides remote communication for one-to-one or group meetings. Signing up, one-to-one meetings and attending a meeting as an invitee are free. The host of a group meeting is charged a monthly fee (CAD 14.99-19.99). All hosting fees were paid by the Sinai Health system.
Before starting the intervention, each participant's internet device was checked for compatibility with Zoom. If the device was not compatible, the participant was loaned a tablet for the duration of the intervention which was returned at the end of the study. Each participant was also trained in the use of their device to connect and use the Zoom platform and had an online intake interview with the tele-MBCT instructor.
Before each session, the host emailed the Zoom link to the participants. At the scheduled time of each group session, participants joined the live streamed session via their computers by using the link and following the on-screen instructions. During the live sessions, each participant was able to see, hear and speak with the group leader and other group members and they each could mute/unmute, turn on/off video, send messages via chat box and leave the session at any time if necessary.
The tele-MBCT instructor was a mental health clinician at the Reitman Centre who had a University of Toronto specialist and applied mindfulness certificate and mindfulness training at Mount Sinai Psychotherapy Institute (MSPI). She had extensive experience in developing and delivering online training and services to professionals and caregivers.
Participants in the intervention group were given a mindfulness package which included a book called "The Mindful Way Workbook" (Teasdale, Williams, and Segal 2014), a practice log and a snack pack of raisins (which was needed for the first session for mindful eating practice). "The Mindful Way Workbook" contains information about emotional distress, MBCT foundation and theories, other individuals' experiences with MBCT, weekly practices/explanations and homework. The book also contains a CD audio guide to each week's mindfulness practice. The practice log was a simple log for self-recording daily practices (number of minutes of daily MBCT practice) and a note pad for recording the reasons/obstacles for not practicing. These logs were anonymous and did not include any personal health information of the participants. At the completion of the tele-MBCT training, participants submitted their logs for analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-identification as a caregiver for a family member diagnosed with any type of dementia
- •English literacy
- •Access to a home computer connected to the Internet
- •Basic familiarity with using a computer (the ability to check email and download files)
- •Score at least 3 on the Single-item measure of self-perceived stress
- •Agree to not engage in any formal community-based caregiver support programs, mind-body programs, or psychotherapy until they have completed training and follow-up evaluations
排除标准
- •Active suicidality and self-harm ideas
- •Recent diagnosis of major depression, severe anxiety, psychosis, and bipolar disorder
- •Active substance misuse
- •Starting on a new psychotropic medication within three months prior to entry into the study
- •Involved in formal, professionally led meditation, yoga, or tai chi programs in the previous year
结局指标
主要结局
Perceived Stress Scale (PSS)- 10-item version
时间窗: Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants
Participant's level of stress
次要结局
- Center for Epidemiologic Studies Depression Scale (CES-D)(Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants)
- Coping Inventory for Stressful Situations- short form CISS-SF(Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants)
- State Anxiety Subscale of the Spielberger State-Trait Anxiety Inventory (STAI-S)(Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants)
- Self-compassion Scale (SCS)(Change from baseline at post-intervention for the intervention group and at 2 months for the control group and Change from baseline at 3 months for all participants)