Evaluation of MoodRing on Improving the Quality of Depression Management in Adolescents (TECH-E)

Ana Radovic

Status: Terminated

Conditions: Depression in Adolescence

Treatments: Other: Usual Care; Device: MoodRing App

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05376358

STUDY21050120

R44MH122067 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

This is a randomized controlled trial to evaluate the efficacy of MoodRing as compared to usual care for adolescents who have a prior diagnosis of depression. Adolescents with depressive symptoms, their parents, and their mental healthcare providers (if interested) will participate in a 6 month study. Adolescents age 12-18 and their parent will be consented for the study and be sent an online survey to obtain baseline measures. Those who complete the baseline measures will then be randomized to receive the MoodRing intervention or treatment as usual. Adolescents and parents will be asked to complete data collection at 3 months and 6 month time points post-randomization by online survey. Additionally, data will be collected for 3 and 6 month timepoints via the adolescent's electronic health record data. At 6 months, online surveys will be sent and an invitation to interview for patients' mental healthcare providers who consent to participate in the study.

Adolescent-parent dyads will be randomized at a 1:1 ratio (using randomized block sizes) to either 1) MoodRing or 2) usual care. 100 adolescent-parent dyads (200 total individuals) will be randomized to MoodRing and 100 adolescent-parent dyads (200 total individuals) will be randomized to usual care. We expect 50 clinicians will participate. In both arms, passively collected data will be obtained from adolescent smartphones as well as weekly mood surveys and monthly sleep surveys. In the 1) MoodRing arm adolescents will download the MoodRing-adolescent app, parents will download the MoodRing-parent app, and healthcare providers if interested will have access to a clinician dashboard. The randomization tables will be generated by the study statistician.

The investigators hypothesize that adolescents who receive MoodRing as compared to usual care will have:

H1: Improved self-management of depression as measured by change of baseline for the average score on the Partners in Health Scale

EH2: The investigators will also explore whether MoodRing as compared to usual care will result in improved quality of depression management as measured by frequency of symptom reassessment, medication adherence, and therapy adherence, less healthcare utilization, decreased depression symptoms, improved sleep quality, and increased application of self-management activities through increased self-efficacy, utilization of self-management skills and knowledge and social support.

H3: The investigators anticipate healthcare providers, adolescents, and parents will report satisfaction with use of MoodRing.

* After date September 2022, we decided to make a change to the protocol and primary outcome. Due to recruitment challenges from mental health clinicians due to their clinical workload, we made a change to recruit adolescents directly including using social media. This introduced more heterogeneity to access to mental health care as well as less access to electronic health records systems that were external to our site which made it less likely to be able to measure quality of depression management. For this reason, the goal to recruit healthcare providers was discontinued. And the primary outcome was changed to self-management, changing our hypothesis to:

We hypothesized that MoodRing will help adolescents better self-manage their depression.

Secondary outcome measures were changed from "change in symptoms" to just that symptom total at 3 months and 6 months for better clinical interpretability.

Enrollment: 73 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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73 participants in 2 patient groups

Usual Care

Active Comparator group

Description:

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.

Treatment:

Other: Usual Care

MoodRing

Experimental group

Description:

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.

Treatment:

Device: MoodRing App