Evaluation of MoodRing on Improving the Quality of Depression Management in Adolescents

NCT05376358 | Terminated Results FDA Device

• 2 other identifiers: STUDY21050120R44MH122067
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

The MoodRing intervention is a mobile application for adolescents, parents, and an accompanying web-based clinician portal which enables adolescents to monitor their mood through the use of passively collected smartphone data. This randomized controlled trial will evaluate whether MoodRing as compared to usual care improves the quality of depression management.

Conditions

Depression in Adolescence

Keywords

Adolescent; Adolescent Medicine; Mental Health Services; eHealth; Mobile Applications; Symptom Management

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Self-management at 3 Months

  Adolescents will be asked the Partners in Health Scale The revised Partners in Health Scale (Smith 2016) assesses self-management with respect to a chronic condition, with regard to active involvement of a patient in managing their condition. Total scores range from 0 to 96 with higher scores indicating worse self-management. A larger negative change in self-management score means an improvement in self-management.

  From baseline to 3 months

Secondary Outcomes (21)

• Quality of Depression Management: Depression Symptom Reassessment

  3 months

• Quality of Depression Management: Medication Adherence

  3 months

• Quality of Depression Management: Therapy Adherence

  3 months

• Healthcare Utilization for Acute Care or Primary Care (for Non Mental-health Reason)

  3 month

• Depression Severity at 3 Months

  3 months

Other Outcomes (18)

• Sleep Habits at 3 Months

  3 months

• Perceived Need for Service Use at 3 Months

  3 months

• Perceived Severity at 3 Months

  3 months

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Participants in this arm will receive no intervention and access treatment as usual per their mental health services provider. A mobile application (AWARE) which is not interactive and is only for purposes of data collection will be downloaded on the adolescents' smartphone.

Other: Usual Care

MoodRing

EXPERIMENTAL

Adolescent participants in this arm will download two mobile applications - a data collection non-interactive app to collect passive sensing data (AWARE) and the MoodRing (MR) mobile application with which they can visualize their data about their mood, sleep, activity, enter their own mood score, and access psychoeducational resources including links to a research-based website, SOVA. Their parents will download a parent MoodRing application which provides them with parenting resources and articles and a weekly report of their adolescents' mood as predicted by passive sensing. Clinical providers will receive access to a web portal where they can view their adolescent patients' data who are enrolled in the study.

Device: MoodRing App

Interventions

MoodRing App DEVICE

Adolescents and parents in the MR arm will receive instructions to download the MR app and AWARE app, customize the app, utilize an app-based self-guided onboarding, and review questions with the research team. The MR app provides the adolescent and their parent a notification to view a weekly report predicting their mood score (i.e. depression severity level similar to the Patient health questionnaire-9). The MR app will provide a library of coping strategies for adolescents and opportunities to self-track their mood. Clinicians in the MR Arm will get access to a MR portal online. They will be able to view patients they are a provider for. The clinician will receive in-person and/or video-based training to use the portal.

MoodRing

Usual Care OTHER

Adolescents and parents in the usual care arm will receive instructions to download the AWARE app. This app will only track data and will not be interactive. Otherwise they will receive care as per routine by their healthcare provider team.

Usual Care

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescent:
• age 12 -18
• prior or present history of depression per self-report and/or clinician diagnosis
• scores between 5 or higher on PHQ-9 consistent with at least mild symptoms of depression
• read and understand English
• has an Android or iOS smartphone compatible with AWARE mobile application and access to a smartphone data plan
• currently in United States
• Parent/Guardian:
• adolescent qualifies for study and assents to enroll
• understands English
• currently in United States
• has a smartphone device that can download the intervention application
• Healthcare Provider:
• \- involved in providing mental health treatment (psychotherapy or antidepressant prescribing or making referrals) to adolescent participant - can be a primary care provider, therapist, subspecialist, psychiatrist

You may not qualify if:

• Adolescent:
• currently actively suicidal (have suicidal thoughts and plan with an intent to act on it)
• plans to travel to countries belonging to the European Union (Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden), the United Kingdom (England, Scotland, Wales, and Northern Ireland), Norway, Iceland, or Lichtenstein in the next 6 months for more than 2 weeks at a time
• Parent:
• \- If their adolescent child is excluded
• Healthcare Provider:
• \- None

Sponsors & Collaborators

• Ana Radovic: lead
• NuRelm, Inc.: collaborator
• National Institute of Mental Health (NIMH): collaborator
• University of Virginia: collaborator

Study Sites (1)

Center for Adolescent and Young Adult Health

Pittsburgh, Pennsylvania, 15213, United States

Location

Limitations and Caveats

The pre-specified statistical analysis plan was not performed as it was not scientifically appropriate due to insufficient enrollment. Due to the complexity of intervention development and the COVID-19 pandemic we were not able to complete our enrollment goals prior to funding ceasing.

Results Point of Contact

• Title: Dr. Ana Radovic
• Organization: University of Pittsburgh

anr94@pitt.edu

4126927227

Study Officials

• Sam Shaaban, BSEE, MBA

  NuRelm, Inc.

  PRINCIPAL INVESTIGATOR

• Ana Radovic, MD, MSc

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Afsaneh Doryab, Ph.D. CS

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will be masked to the intervention condition at follow-up assessment time points.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Model Details: This study will use a parallel study design, where participants are randomized into two intervention groups (Usual Care or MoodRing) and will receive interventions in parallel.

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 17, 2022
• Study Start: May 12, 2022
• Primary Completion: March 27, 2024
• Study Completion: June 20, 2024
• Last Updated: August 14, 2025
• Results First Posted: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)