- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04416529
Tele-Mindfulness for Dementia's Family Caregivers: a Randomized Trial With a Usual Care Control Group
연구 개요
상세 설명
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.
Tele-MBCT was delivered in three, 8-week rounds. Each round consisted of 8 weekly, 2-hour group sessions with 4-6 participants, held via Zoom on Wednesdays from 2:00 to 4:00 pm. For any technical problems during the sessions, participants had telephone access to the instructor.
During tele-MBCT training, participants were trained in mindfulness concepts and techniques including mindful eating, body scan, sitting meditation, breathing awareness, mindful walking and mindful movements. Mindfulness practices, except for mindful walking and mindful movements, were done in a sitting position in a chair or standing. Participants were asked to do the mindful walking with safety measures and in the room in which they were getting the training. The mindful movements were gentle stretches performed in seated and standing positions and were modified to each participant's abilities. At the completion of each session, participants were instructed to practice a specific mindfulness exercise during the week and record them in their practice log. They could use the CD for guided meditation and their home practice. The book also provided them with further readings. At the beginning of the training, participants were asked to set aside 30-45 minutes per day for practice. However, they were free to practice based on their schedule. Participants were permitted to miss up to 2 sessions for unanticipated problems. None of the sessions was audio/video recorded. Missed sessions were made up by reading about the missed session and doing the daily practice according to the book.
For this study, MBCT was modified in two ways for online delivery: omitting the retreat day from the schedule and mindful movements in lying position. In face to face MBCT training, the retreat day is held between sessions 6 and 7 and lasts 5-6 hours, during which individuals spend most of the day together in silence, doing guided practices of the previous sessions. Because of the long hours of the retreat day, it was deemed impractical in an online intervention and omitted. Because of safety issues, it was necessary that all the participants in the group could be seen (via their cameras) by the instructor during the whole training by adjusting the individual's device and finding the best position. This issue was addressed in the Zoom training and the interview with the instructor. Because doing the mindful movement in the lying position required adjustment of the device during the session which was time consuming and challenging, individuals were instructed to do mindful movements only in standing and sitting positions. However, the instructor explained the mindful movements in lying position and encouraged the participants to practice them at home.
Control Group Participants in the control group continued their usual caregiving activities. At 3 months after completion follow-up surveys, they received the "Mindful Way Workbook" and were offered the opportunity to attend the same tele-MBCT training after the study ended.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Intervention (tele-MBCT) group
Tele-MBCT was an 8-week program delivered to participants online via a videoconferencing program called Zoom by a tele-MBCT instructor.
Tele-MBCT was delivered in three, 8-week rounds.
Each round consisted of 8 weekly, 2-hour group sessions with 4-6 participants on Wednesdays from 2:00 to 4:00 pm.
Participants were trained in mindfulness concepts and techniques including mindful eating, body scan, sitting meditation, breathing awareness, mindful walking and mindful movements.
Participants were given a mindfulness a book called "The Mindful Way Workbook" and a practice log.
The book was a guide for their daily practice at home and 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.
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Please see arm/group description.
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간섭 없음: Control Group
Participants in the control group continued their usual caregiving activities.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Perceived Stress Scale (PSS)- 10-item version
기간: 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
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Participant's level of stress
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Center for Epidemiologic Studies Depression Scale (CES-D)
기간: 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
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Participant's symptoms of depression
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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
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State Anxiety Subscale of the Spielberger State-Trait Anxiety Inventory (STAI-S)
기간: 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
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Current anxiety level
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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
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Coping Inventory for Stressful Situations- short form CISS-SF
기간: 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
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Participants' coping responses to stressful situations
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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
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Self-compassion Scale (SCS)
기간: 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
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Participants' level of self-compassion
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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
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Demographics
기간: At baseline
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Age, gender, level of education, employment status, marital status, care-recipient type of dementia, caregiver relationship, living status of the caregiver and care-recipient and length of time as a caregiver.
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At baseline
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Feasibility criteria
기간: Through study completion, an average of 1 year
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Recruitment, retention and compliance rates
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Through study completion, an average of 1 year
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Compliance rate
기간: at 2 months (post-intervention) only for participants in the intervention group
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Participant compliance rates were evaluated based on attendance and practice rate, ability to complete the practice log and satisfaction questionnaire
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at 2 months (post-intervention) only for participants in the intervention group
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Level of Satisfaction
기간: at 2 months (post-intervention) only for participants in the intervention group
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Participants' level of satisfaction with the intervention based on the satisfaction questionnaire that was designed for this study
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at 2 months (post-intervention) only for participants in the intervention group
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공동 작업자 및 조사자
수사관
- 수석 연구원: Joel Sadavoy, MD, FRCPC, Department of Psychiatry, University of Toronto
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Tele-MBCT에 대한 임상 시험
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Lakehead UniversityOntario Neurotrauma Foundation완전한
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NYU Langone HealthNational Center for Complementary and Integrative Health (NCCIH)완전한
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Duke UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)완전한
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Rhode Island HospitalUniversity of Mississippi Medical Center완전한
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University of Alabama at BirminghamEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)완전한
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Baylor College of MedicineBioSensics모병
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Massachusetts General HospitalNational Institute on Aging (NIA)완전한
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University Hospital, Strasbourg, France아직 모집하지 않음