Technology and Emotion Study "TECH-E": Randomized Controlled Trial of MoodRing Compared to Usual Care: Mobile Monitoring of Adolescent Depression Phase II
Phase: NA
Conditions: Depression in Adolescence
Sponsor: Ana Radovic

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Study Protocol  
 
 
 
 
 
 
Official Title: Technology and Emotion Study "TECH-E": Randomized 
Controlled Trial ofMoodRing compared to Usual Care: Mobile 
Monitoring of Adolescent DepressionPhase II 
  
 
 
ClinicalTrials.gov ID (NCT number): NCT05376358 
 
 
 
Protocol Date: 10/14/2022  
 
 
 
 

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Scientific Background 
 
Adolescent depression is increasing and limited numbers access 
treatment. Almost 12% of adolescents have major depression or 
dysthymia. A third experience suicidality and 11% attempt suicide; 
resulting in $12 billion in hospital costs, but only one-third receive 
treatment, and initial treatment delays average 10 years. 
Screening may identify adolescents at risk for depression, who do not 
address their symptoms until they are in crisis. To increase detection of 
depressive symptoms, the US Preventive Service Task Force 
recommends routine screening for major depressive disorder in 
adolescents aged 12 to 18 years. For those who are at risk 
for worsening depression, close follow-up with the primary care 
provider (PCP) is recommended. Most adolescents will wait to seek 
medical attention only when symptoms are severe or they are in crisis . 
Although multiple studies show the benefit of addressing depressive 
symptoms before they worsen, this is not done in practice due to 
difficulty and burden in requiring patients to self-report and lack of 
scheduling and attending frequent follow-up visits. 
Frequent, passive symptom monitoring which detects depression could 
help adolescents monitor their symptoms by employing early self-
management interventions and make parents and clinicians aware of 
symptom worsening to avoid worsened outcomes or a crisis situation. 
Preliminary studies. In the MONARCA project, Frost, Doryab, et al. 
developed a smartphone app to provide disease insights by collecting 
passive data relevant to behavioral trends of bipolar disorder in adults. 
They found patient mood correlated with physical activity, levels of 
stress, sleep, and phone use, and that phone call duration, speech 
analysis, and movement data from smartphones could identify 
manic and depressive states. Their system recognized bipolar states and 
transitions between those states with 76% accuracy based on 12 weeks 
of data with 10 patients. Dr. Doryab led two rounds of data collection at 
CMU where cohorts of 180 (Spring 2017) and 270 (Spring 2018) 
freshmen students were recruited to use AWARE for a semester. 
Baseline, post surveys, and ecological momentary assessment data were 

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collected to support and validate the outcome of machine learning 
models. An analysis of first round data detected post-semester 
depression among freshmen with accuracy of ~86% and change in 
severity levels with accuracy of 78.6%. A machine learning pipeline was 
developed to process data on a sensor by sensor basis to identify the best 
set of sensors that provide the highest accuracy and the minimal set of 
features required for accurate inferences above the majority class 
baselines. 
We adapted this data to adolescents and used their data to replicate the 
analysis, rederiving the algorithms. 
We will use the data collected from the first phase to create an 
application, MoodRing, to provide feedback to adolescents, parents, and 
clinicians on symptom severity using passive sensing technology, to 
understand whether this application improves the quality of depression 
management through increasing the application of self-management 
activities and utilization of timely engagement with healthcare 
as well as exchange of passively monitored mood information between 
adolescents, parents, and providers. 
 
 
Study Objectives 
 
Evaluate the efficacy of MoodRing in a randomized trial. 
 
PRIMARY: 1) Does MoodRing compared to usual care improve the 
self-management of depression (i.e. active involvement of adolescent 
patient in managing their depression)? AT 3 MONTHS 
 
EXPLORATORY: 
2) Does MoodRing compared to usual care improve the quality of 
depression management as measured by:  
 
a) depression symptom reassessment 
 
b) medication adherence in those on medication 
 
c) therapy adherence in those in therapy 
3) Does MoodRing compared to usual care result in: 

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a) less healthcare utilization 
 
b) decreased depressive symptoms 
 
c) improved sleep quality 
 
d) increased application of self-management activities 
3) Is improvement in self-management of depression mediated by 
perceived severity, social support, self-management knowledge and 
skills, and self-efficacy?  
4) Do healthcare providers, adolescents, parents report satisfaction with 
MoodRing? 
 
Study Design & Methods 
 
Randomized trial. Study procedures: We will recruit adolescents with a 
history of depression using similar mechanisms as in the Phase 1 study 
(IRB protocol #18120176). This will include recruitment through 
clinical sites at CAYAH (4 clinical sites) and the University of 
Pittsburgh Research Registry, Pitt+Me, run by the Clinical and 
Translational Science Institute as well as from the STAR center. Most 
participants for the Phase 1 study were successfully recruited through 
the STAR center. We will also recruit using social media 
advertisements. The research assistant (RA) will screen interested 
adolescents for meeting inclusion/exclusion criteria – have a prior or 
present history of depression per self- report and/or clinician diagnosis - 
and enroll those with a score of at least 5 or higher on the PHQ-9 who 
do not have active suicidality. Most adolescents recruited from 
the STAR center will have completed their acute phase of treatment in 
intensive outpatient treatment and will be receiving outpatient 
psychotherapy and/or antidepressant management. Adolescents age 12-
18 and their parent will be consented for the study and be sent an online 
survey for baseline measures. Those who complete the baseline 
measures will then be randomized to receive the MoodRing intervention 
or treatment as usual and asked to complete data collection at 3 months 
and 6 months by online survey. Additionally, data will be collected via 
the electronic health record and from patients' healthcare providers who 
consent to participate in the study. Randomization: Adolescents will be 

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randomized at a 1:1 ratio (using randomized block sizes) to MoodRing 
with feedback to adolescent, parent, and healthcare provider team or to 
usual care with collection of passive sensing and survey data without the 
use of the MoodRing app. The randomization tables will be generated by 
the study statistician. 
 
 
 
 
Eligibility Criteria  
 
Included if 
- 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 
- read and understand English 
- has an Android or iOS smartphone compatible with AWARE APP and 
access to a 
smartphone data plan 
- currently in United States 
 
Excluded if 
- 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 

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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/Guardian 
Included if: 
- adolescent qualifies for study and assents to enroll 
- understands English 
- currently in United States 
- has a smartphone device that can download the intervention application 
 
Excluded if: 
- If their adolescent child is excluded 
 
 
 
Statistical Considerations 
 
The primary outcome is self-management using the Partners in Health 
Scale which is a continuous scale of self-management knowledge and 
behavior. https://www.publish.csiro.au/PY/PY03022 Our planned 
sample would give us the power to detect a small effect size. For the full 
sample (N=200): 80% power (alpha=0.05) to detect cohens d = .40. 
Complete data with 10% dropout (N=180): 80% power (alpha=0.05) to 
detect cohens d = .42." 
 
Data Analysis: Baseline summary statistics will be displayed. The 
CONSORT diagram will be completed to ensure reporting transparency. 
The main outcome for Phase II is self-management of depression. To 
assess intervention efficacy, the primary approach will be an intent to 
treat analysis with a mixed model with a random intercept treatment as 
the effect of interest. Predictors will be treatment, time, and 
treatment*time interaction. Covariates will be age, history of therapy, 
and phq9 total score.