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临床试验/NCT07126275
NCT07126275进行中(未招募)不适用

Mirror Journaling App Study

Child Mind Institute2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年3月12日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
500
试验地点
2
主要终点
Depressive Symptoms

研究概览

简要总结

This study has three primary aims: 1) Validate Mirror's Mood Check feature by measuring convergent validity;2) Assess user experience and acceptability metrics (e.g., usability, engagement, satisfaction) of the Mirror app, with a particular focus on the journaling feature; 3) Assess the impact of guided journaling and mood tracking on depressive and anxious symptoms.

详细描述

BACKGROUND AND SIGNIFICANCE

Depression is a common and serious mental disorder that can negatively affect an individual's thoughts, feelings, and ability to perform daily activities. The onset of depression can occur at any stage of life. The estimated prevalence of depression in childhood is low (1.09%) and the highest in young adulthood (21%) , with a sharp increase seen during adolescence . In 2022, 15.08% of adolescents between the ages of 12 and 17 reported suffering from at least one major depressive episode in the past year. Of those, only 27.2% received consistent treatment. Depression in adolescents, particularly if left untreated, is associated with negative consequences later in life, such as higher levels of substance use disorders, worse health and social functioning, less educational and financial achievement, and increased criminality. Considering these serious and lasting consequences, depression in adolescents is a significant public health issue that deserves proactive approaches to prevent or mitigate its negative impact on individuals and society.

Journaling is recognized as a common, non-pharmacological tool in the management of mental disorders, including depression. Journaling can promote self-reflection and self-awareness, which can help improve mental health (e.g., enhance emotional regulation, reduce stress, facilitate behavioral changes). Although digital journaling can offer equivalent expression and release as traditional journaling with pen and paper, digital journaling has many advantages, such as enhanced accessibility, data organization, data security, analytic potential, and multimedia integration; these features make digital journaling a highly efficient tool for managing mental health. As such, a growing body of research supports the clinical benefits of digital journaling for depression in adults. Yet, the acceptability and efficacy of digital journaling in adolescents are understudied, calling for further investigation.

Mirror is a mobile journaling app developed by the Child Mind Institute (CMI) for youth who want to explore and improve their mental health, particularly addressing symptoms related to depression. Like other mobile journaling apps, the Mirror app enables users to express their thoughts and emotions through multimodal entries (i.e., written, voice, selfie video) and provides prompts to facilitate journal entries. However, the Mirror app offers unique, emotionally supportive features to help users identify and process emotions. First, Mirror users can explore multimodal guided journaling (e.g., video, audio, and written entries with guided prompts); as the app's name suggests, one of the guides encourages users to stand in front of a mirror and start video journaling while making eye contact with themselves. This guided journaling using a mirror can help increase users' self-reflection and self-expression. Second, the Mirror app has a user-centered mood-checking feature ("Mood Check") designed based on the circumplex model of emotions, in which the x- and y-axis represent pleasantness and energy level, respectively. Mirror's Mood Check feature is visually appealing (i.e., two sliders corresponding to the two axes) and allows users to gain more granular insights into their emotional states.

With these unique and user-centered features described above, the Mirror app has great potential for increasing adolescent users' engagement, which could significantly influence the efficacy of digital journaling on mental health. Importantly, the information gained from the proposed study will guide the development of future clinical trials for adolescents suffering from depression.

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 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Prolific users ages 18-25
  • Must reside in the U.S.
  • Must have access to a smart device, and are willing to download an external app (screened by Prolific Academic)
  • Must complete screening form which consists of the Patient Health Questionnaire (PHQ-2) and the Generalized Anxiety Disorder (GAD-7) Scale.
  • Must have mild to moderate depressive or anxiety symptoms, as measured by the screening form

排除标准

  • 未提供

研究组 & 干预措施

Control Group

No Intervention

Information on mental health resources without journaling or mood tracking.

Mirror Guided Journaling + Mood Tracking

Experimental

Structured prompts and regular feedback to facilitate journaling, alongside daily mood tracking in the Mirror App.

干预措施: Mirror App Journaling and Mood Tracking Study (Device)

Mirror Unguided Journaling + Mood Tracking

Experimental

Free-form journaling with access to daily mood tracking in the Mirror app without specific guided prompts.

干预措施: Mirror App Journaling and Mood Tracking Study (Device)

Mirror Mood Tracking Only

Experimental

Daily mood tracking in the Mirror app, without any journaling component.

干预措施: Mirror App Journaling and Mood Tracking Study (Device)

结局指标

主要结局

Depressive Symptoms

时间窗: 12 weeks (including 1 month follow up)

Statistical models including ANOVA and regression will be used to compare changes in depressive symptoms across the four groups. Changes in depressive symptoms will be assessed with the Patient Health Questionnaire 8 item (PHQ-8), which has scores that range from 0-24 with higher scores indicating higher levels of depressive symptoms. Depressive Symptoms will be measured at baseline, post 8-weeks of the intervention, and at a 1 month follow up.

Impairment

时间窗: 12 weeks (including 1 month follow up)

Statistical models including ANOVA and regression will be used to compare changes in impairment across the four groups. Changes in impairment will be assessed with the WHO Disability Assessment Schedule (WHODAS 2.0), which has scores that range from 0-100 with higher scores indicating higher levels of impairment. Impairment will be measured at baseline, post 8-weeks of the intervention, and at a 1 month follow up.

Anxiety Symptoms

时间窗: 12 weeks (including 1 month follow up)

Statistical models including ANOVA and regression will be used to compare changes in anxiety symptoms across the four groups. Changes in anxiety symptoms will be assessed with the Generalized Anxiety Disorders Scale (GAD-7), which has scores that range from 0-24 with higher scores indicating higher levels of anxiety symptoms. Anxiety Symptoms will be measured at baseline, post 8-weeks of the intervention, and at a 1 month follow up.

次要结局

  • User Feedback(8 weeks)
  • User Experience(8 weeks)

研究者

发起方
Child Mind Institute
申办方类型
Other
责任方
Sponsor

研究点 (2)

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