Child Mind Institute
New York, 10022, United States
NCT Number: NCT07126275
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.
This study is active but is not currently recruiting participants.
18 year–25 year
All sexes
Interventional
Not applicable
New York, 10022, United States
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.
PROPOSED STUDY
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.
This study will enroll 500 young adults ages 18-25 via Prolific Academic (https://www.prolific.com/) an online research participant recruitment tool.
Users on Prolific Academic must be the age of majority in the locality in which they register for an account. Prolific users ages 18-25 that reside in the U.S., have access to a smart device, and are willing to download an external app (screened by Prolific Academic), will be eligible to complete a screening form. Participants with mild to moderate depressive or anxiety symptoms will be eligible to enroll in the study.
Participants on Prolific will complete a baseline assessment and will then be randomized to complete one of four study conditions over the course of 8 weeks:
In addition to their journaling and mood check assignments, all participants will also complete a weekly check in questionnaire, post-study and one month follow up assessment of symptoms and user satisfaction with the app.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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. 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 using unique, emotionally supportive features to help users identify and process emotions. Users can also complete free-form, unguided journaling, and can complete daily mood tracking and see changes/progress over time.
Time frame: 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 PROMIS Depression Short Form, which has scores that range from 8-40, with higher scores indicating greater depressive symptom severity. PROMIS was measured at baseline, post-intervention (8 weeks), and at a 1-month follow-up.
PHQ-8 was administered at baseline as a screening instrument to determine eligibility and was also administered at the 8-week assessment. PHQ-8 was not administered at the 1-month follow-up.
This record update corrects an administrative error in the original ClinicalTrials.gov registration, which listed PHQ-8 and GAD-7 as primary outcomes and omitted the PROMIS measures. The IRB-approved protocol dated February 10, 2025, prior to study initiation, specified PROMIS and WHODAS as outcome measures. This update aligns the registration record with the approved protocol.
Time frame: 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 PROMIS Anxiety Short Form, which has scores that range from 7-35, with higher scores indicating greater anxiety symptom severity. PROMIS was measured at baseline, post-intervention (8 weeks), and at a 1-month follow-up.
GAD-7 was administered at baseline as a screening instrument to determine eligibility and was also administered at the 8-week assessment. GAD-7 was not administered at the 1-month follow-up.
This record update corrects an administrative error in the original ClinicalTrials.gov registration, which listed PHQ-8 and GAD-7 as primary outcomes and omitted the PROMIS measures. The IRB-approved protocol dated February 10, 2025, prior to study initiation, specified PROMIS and WHODAS as outcome measures. This update aligns the registration record with the approved protocol.
Time frame: 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.
Time frame: 8 weeks
User experience data will also be collected and analyzed to support product improvement. Data will be collected with the The MAUQ, or mHealth App Usability Questionnaire, a tool used to assess the usability of mobile health (mHealth) applications. It provides a structured way to gather user feedback and determine how easy and useful an app is for its intended purpose using likert scale questions.
Time frame: 8 weeks
User experience data will be collected and analyzed to support product improvement. Data will be collected with the System Usability Scale (SUS), a ten-item Likert scale giving a global view of subjective assessments of usability, which generates a score from 0-100 with higher scores indicating higher levels of usability.
Time frame: 8 weeks
User experience data will be collected and analyzed to support product improvement. Data will be collected with a feedback questionnaire developed by the Child Mind Institute that asks questions specifically about the Mirror platform. The assessment includes both close and open ended questionnaires.
Child Mind Institute
Other
Acronym: Mirror Journal
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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