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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
73
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.
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.
Center for Adolescent and Young Adult Health
Pittsburgh, Pennsylvania, United States
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.
Time frame: From baseline to 3 months
Quality of Depression Management: Depression Symptom Reassessment
Attendance at a healthcare provider visit for depression symptom reassessment within 3 months (yes/no) measured by adolescent or parent self-report (yes if any are yes, no if all are no). The metric reported will be percentage of individuals per study arm with a 'yes' result.
Time frame: 3 months
Quality of Depression Management: Medication Adherence
Out of adolescents who are taking an antidepressant, receipt of at least 60 consecutive days (yes/no) measured by adolescent self-report. The metric reported will be percentage of individuals per study arm with a 'yes' result.
Time frame: 3 months
Quality of Depression Management: Therapy Adherence
Out of adolescents who report being referred for psychotherapy, receipt of at least 3 sessions within 3 months (yes/no) measured by adolescent and parent self-report (yes if any are yes, no if all are no). The metric reported will be percentage of individuals per study arm with a 'yes' result.
Time frame: 3 months
Healthcare Utilization for Acute Care or Primary Care (for Non Mental-health Reason)
Average Number of visits for (greater number as reported by adolescent self-report and parent self-report): 1. urgent care; 2. emergency room; 3. inpatient hospitalization; 4. acute primary care provider visit for non-mental health related concern; 5. medical subspecialist visit 6. surgical subspecialist visit
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Time frame: 3 month
Depression Severity at 3 Months
Adolescents will be asked the PHQ-9 Patient Health Questionnaire-9 measures depression severity with a score ranging from 0 to 27, a higher score indicating greater severity.
Time frame: 3 months
Sleep-Related Impairment at 3 Months
Adolescents will respond to the PROMIS Pediatric Sleep-Related Impairment scale. This scale has four questions with response options of never, almost never, sometimes, almost always, and always, ranges from 4 to 19 with higher scores indicating higher levels of sleep-related impairment.
Time frame: 3 months
Sleep Disturbance at 3 Months
Adolescents will respond to the PROMIS Pediatric Sleep Disturbance scale. This scale has four questions, the second (sleeping through the night) being reverse-scored, with response options of never, almost never, sometimes, almost always, and always, ranges from 4 to 20 with higher scores indicating higher levels of sleep disturbance.
Time frame: 3 months
Self-Efficacy at 3 Months
Adolescents will be asked the Mental Health Self-efficacy Scale (MHSES) The Mental Health Self-efficacy Scale (Clarke, 2014) measures one's belief in one's capability to perform mental health self-care behaviors. The score ranges from 6 to 60, with higher scores indicating higher confidence in mental health selfcare.
Time frame: 3 months
Self-management Behavior at 3 Months
Adolescents will be asked based on Question 12 of Partners in Health Scale about self-management behavior. This question asks the average amount of time (options including Daily, More than once a week, Once a week, Once a month, Once a semester, Once a year, Less than once a year, Never) spent in potentially useful self-management activities. Each time category will be described by a percentage. Each of the following are asked individually: (1) created to-do lists to help me focus; (2) found strategies to create pleasurable distractions; (3) engaged in some physical activity (cycling, walking, etc.); (4) set realistic short-term goals; (5) made sure I had a good day/night routine with got enough sleep; (6) ensured enough rest to avoid getting exhausted; (7) left the house regularly; (8) ate healthy A higher score indicates a better outcome.
Time frame: 3 months
Social Support at 3 Months
Adolescents will be asked the Medical Outcomes Study Social Support Survey The Medical Outcome Study Social Support Scale (Sherbourne, 1991) measures types of social support. Each item ranges from 1 to 5 and the total score is averaged and ranges from 1 to 5, with higher levels associated with greater support.
Time frame: 3 months
Change in Self-management at 6 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.
Time frame: From baseline to 6 months
Quality of Depression Management: Depression Symptom Reassessment
Attendance at a healthcare provider visit for depression symptom reassessment within the past 3 months (yes/no) measured by adolescent, parent self-report and electronic health record review (yes if any are yes, no if all are no). The metric reported will be percentage of individuals per study arm with a 'yes' result.
Time frame: 6 months
Quality of Depression Management: Medication Adherence
Out of adolescents who are taking an antidepressant, receipt of at least 60 consecutive days (yes/no) within the past 3 months, measured by adolescent, parent self-report and electronic health record review (yes if any are yes, no if all are no). The metric reported will be percentage of individuals per study arm with a 'yes' result.
Time frame: 6 months
Quality of Depression Management: Therapy Adherence
Out of adolescents who are referred for psychotherapy, receipt of at least 3 sessions within the past 3 months (yes/no) measured by adolescent, parent self-report and electronic health record review (yes if any are yes, no if all are no). The metric reported will be percentage of individuals per study arm with a 'yes' result.
Time frame: 6 months
Healthcare Utilization for Acute Care or Primary Care (for Non Mental-health Reason)
Number of visits for (combined total between adolescent self-report, parent self-report, and electronic health-record review): 1. urgent care; 2. emergency room; 3. inpatient hospitalization; 4. acute primary care provider visit for non-mental health related concern; 5. medical or surgical subspecialist visit
Time frame: 6 month
Depression Severity at 6 Months
Adolescents will be asked the PHQ-9 Patient Health Questionnaire-9 measures depression severity with a score ranging from 0 to 27, a higher score indicating greater severity.
Time frame: 6 months
Self-management Behavior at 6 Months
Adolescents will be asked based on Question 12 of Partners in Health Scale about self-management behavior. This question asks the average amount of time (options including Daily, More than once a week, Once a week, Once a month, Once a semester, Once a year, Less than once a year, Never) spent in potentially useful self-management activities. Each of the following are asked individually: (1) created to-do lists to help me focus; (2) found strategies to create pleasurable distractions; (3) engaged in some physical activity (cycling, walking, etc.); (4) set realistic short-term goals; (5) made sure I had a good day/night routine with got enough sleep; (6) ensured enough rest to avoid getting exhausted; (7) left the house regularly; (8) ate healthy
Time frame: 6 months
Self-Efficacy at 6 Months
Adolescents will be asked the Mental Health Self-efficacy Scale (MHSES) The Mental Health Self-efficacy Scale (Clarke, 2014) measures one's belief in one's capability to perform mental health self-care behaviors. The score ranges from 6 to 60, with higher scores indicating higher confidence in mental health selfcare.
Time frame: 6 months
Social Support at 6 Months
Adolescents will be asked the Medical Outcomes Study Social Support Survey The Medical Outcome Study Social Support Scale (Sherbourne, 1991) measures types of social support. Each item ranges from 1 to 5 and the total score is averaged and ranges from 1 to 5, with higher levels associated with greater support.
Time frame: 6 months
Sleep-Related Impairment at 6 Months
Adolescents will respond to the PROMIS Pediatric Sleep-Related Impairment scale. This scale has four questions with response options of never, almost never, sometimes, almost always, and always, ranges from 4 to 19 with higher scores indicating higher levels of sleep-related impairment.
Time frame: 6 months
Sleep Disturbance at 6 Months
Adolescents will respond to the PROMIS Pediatric Sleep Disturbance scale. This scale has four questions, the second (sleeping through the night) being reverse-scored, with response options of never, almost never, sometimes, almost always, and always, ranges from 4 to 20 with higher scores indicating higher levels of sleep disturbance.
Time frame: 6 months