Clinical trial NCT05376358: Evaluation of MoodRing on Improving the Quality of Depression Management in Adolescents
Official title: Technology and Emotion Study "TECH-E": Randomized Controlled Trial of MoodRing Compared to Usual Care: Mobile Monitoring of Adolescent Depression Phase II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression in Adolescence
Keywords: Adolescent
Adolescent Medicine
Mental Health Services
eHealth
Mobile Applications
Symptom Management
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: NuRelm, Inc.
name: National Institute of Mental Health (NIMH)
name: University of Virginia
First posted: 2022-05-17
Enrollment: 146
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Self-management at 3 months
timeFrame: From baseline to 3 months
Secondary outcomes:
measure: Change from Baseline in Self-management at 6 months
timeFrame: From baseline to 6 months
measure: Quality of Depression Management: Depression Symptom Reassessment change from baseline
timeFrame: 6 months
measure: Quality of Depression Management: Medication Adherence
timeFrame: 6 months
measure: Quality of Depression Management: Therapy Adherence
timeFrame: 6 months
measure: Healthcare Utilization for acute care or primary care (for non mental-health reason)
timeFrame: 3 month
measure: Healthcare Utilization for acute care or primary care (for non mental-health reason)
timeFrame: 6 month
measure: Change from Baseline in Depression Severity at 3 months
timeFrame: From baseline to 3 months
measure: Change from Baseline in Depression Severity at 6 months
timeFrame: From baseline to 6 months
measure: Change from Baseline in Self-management behavior at 3 months
timeFrame: From baseline to 3 months
measure: Change from Baseline in Self-management behavior at 6 months
timeFrame: From baseline to 6 months
measure: Change from Baseline in Self-Efficacy at 3 months
timeFrame: From baseline to 3 months
measure: Change from Baseline in Self-Efficacy at 6 months
timeFrame: From baseline to 6 months
measure: Change from Baseline in Social Support at 3 months
timeFrame: From baseline to 3 months
measure: Change from Baseline in Social Support at 6 months
timeFrame: From baseline to 6 months
measure: Change from Baseline in Sleep-Related Impairment at 3 months
timeFrame: From baseline to 3 months
measure: Change from Baseline in Sleep-Related Impairment at 6 months
timeFrame: From baseline to 6 months
measure: Ongoing Change in Sleep-Related Impairment
timeFrame: monthly up to 6 months
measure: Change from Baseline in Sleep Disturbance at 3 months
timeFrame: From baseline to 3 months
measure: Change from Baseline in Sleep Disturbance at 6 months
timeFrame: From baseline to 6 months
measure: Ongoing Change in Sleep Disturbance
timeFrame: monthly up to 6 months
measure: Change from Baseline in Sleep Habits at 3 months
timeFrame: From baseline to 3 months
measure: Change from Baseline in Sleep Habits at 6 months
timeFrame: From baseline to 6 months
measure: Ongoing Change in Sleep Habits
timeFrame: monthly up to 6 months
measure: Change from Baseline in Perceived Severity at 3 months
timeFrame: From baseline to 3 months
measure: Change from Baseline in Perceived Severity at 6 months
timeFrame: From baseline to 6 months
measure: Change from Baseline in Perceived Need for Service Use at 3 months
timeFrame: From baseline to 3 months
measure: Change from Baseline in Perceived Need for Service Use at 6 months
timeFrame: From baseline to 6 months
measure: Quality of Depression Management: Depression Symptom Reassessment
timeFrame: 3 months
measure: Quality of Depression Management: Medication Adherence
timeFrame: 3 months
measure: Quality of Depression Management: Therapy Adherence
timeFrame: 3 months
Other outcomes:
measure: Acceptability of MoodRing: Heathcare Provider Acceptability
timeFrame: at 6 months
measure: Acceptability of MoodRing as a clinical tool: Heathcare Provider Acceptability
timeFrame: at 6 months
measure: Acceptability of MoodRing: Adolescent/Parent Acceptability
timeFrame: at 6 months
measure: Acceptability of MoodRing as a self-management tool: Adolescent/Parent Acceptability
timeFrame: at 6 months
measure: Ongoing Assessment of Depression Severity
timeFrame: Weekly up to 6 months
measure: Change from Baseline in Anxiety severity at 3 months
timeFrame: From baseline to 3 months
measure: Change from Baseline in Anxiety severity at 6 months
timeFrame: From baseline to 6 months
measure: Change from Baseline in Parent-Teen Communication Quality at 3 months
timeFrame: From baseline to 3 months
measure: Change from Baseline in Parent-Teen Communication Quality at 6 months
timeFrame: From baseline to 6 months
measure: Change from Baseline in Parent-Teen Relationship Quality at 3 months
timeFrame: From baseline to 3 months
measure: Change from Baseline in Parent-Teen Relationship Quality at 6 months
timeFrame: From baseline to 6 months
measure: Suicidal Thoughts
timeFrame: 3 months
measure: Suicidal Thoughts
timeFrame: 6 months
measure: Suicidal Thoughts
timeFrame: 3 months
measure: Suicidal Thoughts
timeFrame: 6 months
Locations:
city: Pittsburgh
country: United States
facility: Center for Adolescent and Young Adult Health
state: Pennsylvania
Study officials:
affiliation: NuRelm, Inc.
name: Sam Shaaban, BSEE, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Ana Radovic, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia
name: Afsaneh Doryab, Ph.D. CS
role: PRINCIPAL_INVESTIGATOR
References: