NCT07126275

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress83%
Mar 2025Aug 2026

First Submitted

Initial submission to the registry

February 11, 2025

Completed
29 days until next milestone

Study Start

First participant enrolled

March 12, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 17, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

February 11, 2025

Last Update Submit

March 6, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Depressive Symptoms

    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.

    12 weeks (including 1 month follow up)

  • Anxiety Symptoms

    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.

    12 weeks (including 1 month follow up)

  • Impairment

    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.

    12 weeks (including 1 month follow up)

Secondary Outcomes (3)

  • User Experience

    8 weeks

  • User Experience

    8 weeks

  • User Feedback

    8 weeks

Study Arms (4)

Mirror Guided Journaling + Mood Tracking

EXPERIMENTAL

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

Device: Mirror App Journaling and Mood Tracking Study

Mirror Unguided Journaling + Mood Tracking

EXPERIMENTAL

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

Device: Mirror App Journaling and Mood Tracking Study

Mirror Mood Tracking Only

EXPERIMENTAL

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

Device: Mirror App Journaling and Mood Tracking Study

Control Group

NO INTERVENTION

Information on mental health resources without journaling or mood tracking.

Interventions

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.

Mirror Guided Journaling + Mood TrackingMirror Mood Tracking OnlyMirror Unguided Journaling + Mood Tracking

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child Mind Institute

New York, New York, 10022, United States

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Michael Milham, MD, PhD

    Child Mind Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2025

First Posted

August 17, 2025

Study Start

March 12, 2025

Primary Completion

July 15, 2025

Study Completion (Estimated)

August 1, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations