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临床试验/NCT04841603
NCT04841603已完成不适用

Brief Digital CBT for Mood and Anxiety Symptoms in Acute Psychiatric Inpatients: a Randomized Feasibility Trial

Centre for Addiction and Mental Health2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年4月12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
24
试验地点
2
主要终点
Retention rates

研究概览

简要总结

A randomized control trial examining the feasibility, acceptability, and preliminary efficacy of providing access to the MindShift CBT mobile app via tablet for acute psychiatric inpatients.

详细描述

Psychiatric inpatients expect more psychosocial intervention during their inpatient stay than they receive. During the COVID-19 pandemic, existing interventions have been further reduced. Mood and anxiety symptoms are common for all inpatients across diagnostic categories. Studies have shown that cognitive behavioural therapy (CBT) can be effective for treating these symptoms among inpatients. The purpose of this study is to determine whether the Mindshift CBT app (an app based on principles of cognitive behavioural therapy) is an acceptable, feasible, and useable intervention for inpatients.

The Mindshift CBT app is a tool designed and maintained by Anxiety Canada. It includes tools for daily mood check-ins, healthy thinking, calming intense emotions, and taking actions to change behaviours associated with anxiety and low mood. It also includes information about the common types of anxiety.

The proposed trial includes 12 patients per arm. All participants in control and intervention groups will have access to assigned tablet devices throughout the study period, though only those in the intervention group will have the MindShift CBT app on their device. All participants will undergo assessments at baseline and at the end of the intervention period (1 week).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

入选标准

  • Admitted to the acute inpatient unit
  • Fluent in English
  • Dynamic Appraisal for Situational Aggression (DASA) score <=3
  • Capable to consent to participation as assessed by the treating physician

排除标准

  • Diagnosis of moderate-severe learning disability
  • Diagnosis of moderate-severe neurocognitive disorder

结局指标

主要结局

Retention rates

时间窗: 1 week

Feasibility - whether the intervention is possible in the acute inpatient setting

Client Satisfaction Questionnaire 8 (CSQ-8)

时间窗: 1 week

Acceptability - whether the intervention is appropriate for the acute inpatient setting. The CSQ-8 scores range from 8 to 32, with higher values indicating higher satisfaction with the intervention.

Recruitment rates

时间窗: 1 week

Feasibility - whether the intervention is possible in the acute inpatient setting

User Experience Questionnaire (UXQ)

时间窗: 1 week

Usability - whether the intervention is serviceable for its intended purpose. The UXQ has 11 items exploring characteristics informing usability of mobile apps, each scored from 0-10, for a total score ranging from 10-110 (with larger scores indicating increased usability).

Qualitative Data Analysis

时间窗: 1 week

From focus groups, to inform feasibility, usability, and acceptability

次要结局

  • General Anxiety Disorder 7 Scale (GAD-7)(1 week)
  • Patient Health Questionnaire 9 (PHQ-9)(1 week)
  • Kessler Psychological Distress Scale (K10)(1 week)

研究者

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

Gaurav Sharma

Resident Physician

Centre for Addiction and Mental Health

研究点 (2)

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