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临床试验/NCT05211960
NCT05211960已完成不适用

Effects of a Mindfulness App for Outpatients Waitlisted for Psychological Interventions

Centre for Addiction and Mental Health1 个研究点 分布在 1 个国家目标入组 193 人开始时间: 2022年1月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
193
试验地点
1
主要终点
WHO Disability Assessment Schedule (WHODAS 2.0) Short Form

研究概览

简要总结

The purpose of this study is to evaluate a mindfulness-based meditation app provided to outpatients (or community participants) who are waitlisted for standard psychological care for mental health or substance use concerns.

详细描述

This project aims to provide a previously validated mindfulness meditation app to up to 200 adults waitlisted for psychological services in a psychiatric hospital setting or in the broader community. Outpatients (or community participants) who have been referred to and waitlisted for treatment for their mood, anxiety, alcohol, and/or substance use concerns, will be offered access to the digital intervention for 1 year. We will follow participants for 3 months to evaluate usability and psychological symptoms.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

All participants will be recruited knowing that a mindfulness app will be provided.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •18-65 years of age
  • •Fluency in English
  • •Understanding and willingness to comply with study requirements
  • •Waitlisted for outpatient psychosocial programming at CAMH (or psychosocial programming in the community)
  • •Smartphone or tablet capable of downloading and running the mindfulness app.

排除标准

  • •Any known practical factor that would preclude participation (e.g., extended absences)
  • •Acute psychiatric (e.g., acute suicidality, psychosis) or serious medical condition that precludes participation in this study.
  • •Participation in another treatment/intervention study

研究组 & 干预措施

Treatment

Experimental

AmDTx is a mindfulness-based meditation app that includes lessons, interactive exercises, and additional in-app features to practice mindfulness. Participants will receive a premium account for 1 year; the current study will evaluate outcomes over 3 months. The intervention will be delivered concurrently with treatment as usual which includes standard psychosocial care as participants are referred to their respective programs.

干预措施: Mindfulness-based meditation (Behavioral)

结局指标

主要结局

WHO Disability Assessment Schedule (WHODAS 2.0) Short Form

时间窗: 30 days

Level of functional disability in the past month across six subdomains. Minimum score: 0, Maximum score: 48. Higher scores mean worse outcome.

次要结局

  • Five Factor Mindfulness Questionnaire, Short Form (FFMQ-SF)(30 days)
  • Perceived Stress Scale(30 days)
  • Ruminative Response Scale, Short Form (Treynor & Nolen-Hoeksema, 2003)(30 days)
  • MHealth App Usability Questionnaire(30 days)
  • Patient Health Questionnaire (PHQ-9) Depression Subscale(14 days)
  • Generalized Anxiety Disorder 7 (GAD-7) Scale(14 days)
  • Work Productivity and Activity Impairment(30 days)
  • Repetitive Thinking Questionnaire(30 days)
  • Penn State Worry Questionnaire(30 days)
  • Treatment Acceptability Questionnaire (Hunsley, 1992)(30 days)
  • Philadelphia Mindfulness Scale(30 days)

研究者

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

Lena Quilty

Senior Scientist

Centre for Addiction and Mental Health

研究点 (1)

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