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临床试验/NCT03067207
NCT03067207已完成不适用

A Randomized-Control Trial of an In-Person vs e-Health Mindfulness-Based Intervention for Adolescents With Chronic Illness

The Hospital for Sick Children0 个研究点目标入组 18 人开始时间: 2016年11月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
18
主要终点
Mindfulness Skills Acquisition

研究概览

简要总结

This study will seek to compare the effect of a mindfulness meditation program for adolescents with chronic illness delivered either in person or via an online platform. The 8-week program will combine meditation practices, breathing exercises and group discussions. Participants will be recruited from different general and specialized clinics at the Hospital for Sick Children and will be allocated to either an in-person or the online group through a random process (like tossing a coin). The study will aim to recruit 60 participants ages 13-18. Each participant will provide data through research questionnaires, recorded interviews and saliva samples.

详细描述

The study will be conducted as a longitudinal randomized controlled trial comparing in-person and eHealth delivery of a mindfulness meditation intervention for adolescents with chronic illness. There will be two arms. An experimental and a feasibility arm. In the experimental arm, 4 groups of 10-15 participants will be formed: two in-person groups (early and late) and two eHealth groups (early and late). The early groups will receive the intervention at the beginning of the study period and the late groups will be wait-list controlled group that will receive the intervention at the middle of the study period. At the end of the recruitment period or when the target number of participants is met (60), whichever comes first, all teens meeting the inclusion criteria will be randomly allocated to one of the four randomized groups. Teens who are not meeting the final inclusion criteria (able to attend mindfulness sessions at Sickkids) will be offered a spot in the feasibility arm of the study until the maximum total number of study participants is reached (60). These participants will be placed in eHealth groups (either early or late) through a separate randomization process.

Data collection will take place at baseline (during the intake meeting), immediately before and following the mindfulness intervention as well as at the end of the 6-month study period. Participants in the experimental arm will provide data through research questionnaires, salivary cortisol analysis as well as individual semi-structured interviews with a research assistant. Salivary samples will be provided from home for participants in the eHealth groups. Participants in the feasibility arm will only provide information through research questionnaires.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Supportive Care
盲法
Single (Investigator)

盲法说明

This study will be a single-blinded study (investigators only). Participants will be coded using Arabic numerals. A research assistant will receive all questionnaires and cortisol samples. Mindfulness facilitators will be unaware of participant identification numbers. Participants will be assigned to one of four groups (experimental arm) or to one of two groups (feasibility arm) following a computer-generated randomization list (permuted block design, using blocks of two or four). The allocation sequence will be generated by a statistician not otherwise involved in the project and passed on to a research assistant after patient identification data has been collected (ensuring that the investigators are kept blind to the allocation of each participant). Allocation sequence will be password-protected and only accessible by the statistician and research assistant.

入排标准

年龄范围
13 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of chronic illness
  • Fluent in English
  • Followed by a care provider at the Hospital for SickKids
  • Able to consent to the study
  • Able to attend in-person mindfulness meditation sessions at Sickkids (for the experimental arm only)

排除标准

  • Active and unaddressed suicidal ideation
  • Developmental disability preventing participation in the mindfulness program

结局指标

主要结局

Mindfulness Skills Acquisition

时间窗: Up to 6 months

Acquisition of mindfulness skills as measured by the MAAS-A questionnaire a 14-item Likert-type scale that has been validated in adolescents.

次要结局

  • Anxiety and depression score(Up to 6 months)
  • Salivary cortisol levels(Up to 6 months)
  • Perception of Illness(Up to 6 months)
  • Appreciation of the mindfulness intervention(Up to 6 months)
  • Mindfulness home-practice(Up to 6 months)
  • Self-Esteem(Up to 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Miriam Kaufman

Division Head, Adolescent Medicine

The Hospital for Sick Children

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