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

Depression in Adolescence Clinical Trial

— TECH-E  

Official title:

Technology and Emotion Study "TECH-E": Randomized Controlled Trial of MoodRing Compared to Usual Care: Mobile Monitoring of Adolescent Depression Phase II

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05376358
• Other study ID #: STUDY21050120
• Secondary ID: R44MH122067
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 12, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: January 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: April 30, 2024
• Est. primary completion date: March 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression in Adolescence
• Depressive Disorder

Intervention

Device:
• MoodRing App
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.

Other:
• Usual Care
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.

Locations

Country	Name	City	State
United States	Center for Adolescent and Young Adult Health	Pittsburgh	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Ana Radovic	National Institute of Mental Health (NIMH), NuRelm, Inc., University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability of MoodRing: Heathcare Provider Acceptability	System Usability Questionnaire (Bangor, 2008) asks 11 questions about the usability of a technological intervention. SUS scores range from 0-100. Higher scores indicate better usability.	at 6 months
Other	Acceptability of MoodRing as a clinical tool: Heathcare Provider Acceptability	Acceptability of Intervention Measure (AIM) (Weiner, 2017) asks 4 questions on a 1-5 Likert scale with completely disagree to completely agree with regards to acceptability of an intervention and 3 questions were added including with regards to efficiency, help taking care of patients, patient benefit from the intervention. Higher scores indicate higher acceptability. Also an open-ended question will be asked about feedback using MoodRing.	at 6 months
Other	Acceptability of MoodRing: Adolescent/Parent Acceptability	System Usability Questionnaire (Bangor, 2008) asks 11 questions about the usability of a technological intervention. SUS scores 0-100. Higher scores indicate better usability. Adolescents and Parents - only those randomized to the MoodRing arm - will be asked these questions.	at 6 months
Other	Acceptability of MoodRing as a self-management tool: Adolescent/Parent Acceptability	Acceptability of Intervention Measure (AIM) (Weiner, 2017) asks 4 questions on a 1-5 Likert scale with completely disagree to completely agree with regards to acceptability of an intervention. Additional questions will be asked about perceived benefit, taking care of mental health, and confidence in mental health management. Higher scores indicate higher acceptability. Also an open-ended question will be asked about feedback using MoodRing. Adolescents and Parents - only those randomized to the MoodRing arm - will be asked these questions.	at 6 months
Other	Ongoing Assessment of Depression Severity	Adolescents will be asked the PHQ-8. Patient Health Questionnaire-8 measures depression severity with a score ranging from 0 to 24, a higher score indicating greater severity.	Weekly up to 6 months
Other	Change from Baseline in Anxiety severity at 3 months	Adolescents will be asked the GAD-7 Generalized Anxiety Disorders 7-item Questionnaire measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.	From baseline to 3 months
Other	Change from Baseline in Anxiety severity at 6 months	Adolescents will be asked the GAD-7 Generalized Anxiety Disorders 7-item Questionnaire measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.	From baseline to 6 months
Other	Change from Baseline in Parent-Teen Communication Quality at 3 months	M-PACS (The Parent-Adolescent Communication Scale (Olson, 1985) modified for mental health) asks 20 questions with regards to communication between parents and adolescents, with responses 1-5 from strongly disagree to strongly agree. Some items are reverse scored with a higher scale score indicating better communication. Both adolescents and parents will be asked these questions.	From baseline to 3 months
Other	Change from Baseline in Parent-Teen Communication Quality at 6 months	M-PACS (The Parent-Adolescent Communication Scale (Olson, 1985) modified for mental health) asks 20 questions with regards to communication between parents and adolescents, with responses 1-5 from strongly disagree to strongly agree. Some items are reverse scored with a higher scale score indicating better communication. Both adolescents and parents will be asked these questions.	From baseline to 6 months
Other	Change from Baseline in Parent-Teen Relationship Quality at 3 months	The CPCS (Child Parent Connectedness Scale) asks 5 questions from a scale of 1-5 from strongly disagree to strongly agree with regards to connectedness and relationship satisfaction with each other. A higher score indicates higher child-parent connectedness. Both adolescents and parents will be asked these questions.	From baseline to 3 months
Other	Change from Baseline in Parent-Teen Relationship Quality at 6 months	The CPCS (Child Parent Connectedness Scale) asks 5 questions from a scale of 1-5 from strongly disagree to strongly agree with regards to connectedness and relationship satisfaction with each other. A higher score indicates higher child-parent connectedness. Both adolescents and parents will be asked these questions.	From baseline to 6 months
Other	Suicidal Thoughts	Adolescents who respond with anything besides "none" to the 9th question of the PHQ-9 will be asked to complete the brief CSSR-S scale. This scale asks two questions, have you (the participant) wished you (the participant) were dead or wished you (the participant) could go to sleep and not wake up? (yes/no) and have you (the participant) actually had any thoughts of killing yourself? (yes/no). Positive answers indicate suicidal thinking. These will be asked on an online survey. Those adolescents responding positively will complete a full CSSR-S interview.	3 months
Other	Suicidal Thoughts	Adolescents who respond with anything besides "none" to the 9th question of the PHQ-9 will be asked to complete the brief CSSR-S scale. This scale asks two questions, have you (the participant) wished you (the participant) were dead or wished you (the participant) could go to sleep and not wake up? (yes/no) and have you (the participant) actually had any thoughts of killing yourself? (yes/no). Positive answers indicate suicidal thinking. These will be asked on an online survey. Those adolescents responding positively will complete a full CSSR-S interview.	6 months
Other	Suicidal Thoughts	Adolescents who respond with positive answers to the brief CSSR-S will complete the full CSSR-S interview. The Columbia-Suicide Severity Rating Scale (C-SSRS) consists of interview questions regarding suicidal ideation, intensity of ideation, and suicidal behavior and will be asked with regards to preceeding 3 months. Researchers evaluate responses and categorize suicide severity based on these.	3 months
Other	Suicidal Thoughts	Adolescents who respond with positive answers to the brief CSSR-S will complete the full CSSR-S interview. The Columbia-Suicide Severity Rating Scale (C-SSRS) consists of interview questions regarding suicidal ideation, intensity of ideation, and suicidal behavior and will be asked with regards to preceeding 3 months. Researchers evaluate responses and categorize suicide severity based on these.	6 months
Primary	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.	From baseline to 3 months
Secondary	Change from Baseline 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.	From baseline to 6 months
Secondary	Quality of Depression Management: Depression Symptom Reassessment change from baseline	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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): urgent care; emergency room; inpatient hospitalization; acute primary care provider visit for non-mental health related concern; medical or surgical subspecialist visit	3 month
Secondary	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): urgent care; emergency room; inpatient hospitalization; acute primary care provider visit for non-mental health related concern; medical or surgical subspecialist visit	6 month
Secondary	Change from Baseline in 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.	From baseline to 3 months
Secondary	Change from Baseline in 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.	From baseline to 6 months
Secondary	Change from Baseline in Self-management behavior at 3 months	Adolescents will be asked Question 11 of Partners in Health Scale; and the average amount of time (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: (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	From baseline to 3 months
Secondary	Change from Baseline in Self-management behavior at 6 months	Adolescents will be asked Question 11 of Partners in Health Scale; and the average amount of time (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: (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	From baseline to 6 months
Secondary	Change from Baseline in 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.	From baseline to 3 months
Secondary	Change from Baseline in 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.	From baseline to 6 months
Secondary	Change from Baseline in 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. This subscale ranges from 0-100, with higher levels associated with greater support.	From baseline to 3 months
Secondary	Change from Baseline in 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. This subscale ranges from 0-100, with higher levels associated with greater support.	From baseline to 6 months
Secondary	Change from Baseline in 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.	From baseline to 3 months
Secondary	Change from Baseline in 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.	From baseline to 6 months
Secondary	Ongoing Change in Sleep-Related Impairment	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.	monthly up to 6 months
Secondary	Change from Baseline in 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.	From baseline to 3 months
Secondary	Change from Baseline in 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.	From baseline to 6 months
Secondary	Ongoing Change in Sleep Disturbance	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.	monthly up to 6 months
Secondary	Change from Baseline in Sleep Habits at 3 months	Adolescents will respond to the School Based Sleep Habits Survey-Child Form which asks 43 questions about weekday and weeknight sleep patterns, sleep awakenings, and sleep time preferences.	From baseline to 3 months
Secondary	Change from Baseline in Sleep Habits at 6 months	Adolescents will respond to the School Based Sleep Habits Survey-Child Form which asks 43 questions about weekday and weeknight sleep patterns, sleep awakenings, and sleep time preferences.	From baseline to 6 months
Secondary	Ongoing Change in Sleep Habits	Adolescents will respond to the School Based Sleep Habits Survey-Child Form which asks 43 questions about weekday and weeknight sleep patterns, sleep awakenings, and sleep time preferences.	monthly up to 6 months
Secondary	Change from Baseline in Perceived Severity at 3 months	Rating scale of General Mental Health A rating scale of General Mental Health (Cadigan, 2018) will be used with two questions each ranging from 1 to 5 with regard to a self-rating of general mental health. Adolescents will be asked this and parents about their perception of their adolescent's mental health.	From baseline to 3 months
Secondary	Change from Baseline in Perceived Severity at 6 months	Rating scale of General Mental Health A rating scale of General Mental Health (Cadigan, 2018) will be used with two questions each ranging from 1 to 5 with regard to a self-rating of general mental health. Adolescents will be asked this and parents about their perception of their adolescent's mental health.	From baseline to 6 months
Secondary	Change from Baseline in Perceived Need for Service Use at 3 months	The General-practice Users Perceived-need Inventory (GUPI) The General-Practice Users Perceived-Need Inventory (McNab, 2004) will be used to measure perceived need for treatment. There is no scoring. Adolescents will be asked this and parents about their perception of their adolescent's need for mental health services. The response will be evaluated by the total number of individuals who agree that they would like to or are already getting help with a) medication and b) counseling as comapred to those who respond they do not need this kind of help.	From baseline to 3 months
Secondary	Change from Baseline in Perceived Need for Service Use at 6 months	The General-practice Users Perceived-need Inventory (GUPI) The General-Practice Users Perceived-Need Inventory (McNab, 2004) will be used to measure perceived need for treatment. There is no scoring. Adolescents will be asked this and parents about their perception of their adolescent's need for mental health services. The response will be evaluated by the total number of individuals who agree that they would like to or are already getting help with a) medication and b) counseling as comapred to those who respond they do not need this kind of help.	From baseline to 6 months
Secondary	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, 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.	3 months
Secondary	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, 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.	3 months
Secondary	Quality of Depression Management: Therapy Adherence	Out of adolescents who are referred for psychotherapy, receipt of at least 3 sessions within 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.	3 months