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Improving Mental Health in Youth and Lowering Risk for Obesity Through a Digital Preventative Product
N/A
Waitlist Available
Led By Nick Allen, PhD
Research Sponsored by Ksana Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a mobile app called Vira to help young people with depression and weight issues. Some will also get help from a health coach. The app gives health tips and tracks progress, while the coach provides extra support.
Eligible Conditions
- Mental Health Disorders
- Obesity
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability of the mobile app intervention
Change in depressive symptoms
Number of active days in the Vira mobile app intervention and health coaching platform
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Vira Self-CareExperimental Treatment1 Intervention
The Vira app is installed on the participant's phone. The app passively collects data from phone sensors (i.e., measures of physical activity, sleep patterns, mobility, and language patterns reflecting mood states and cognition) that are indicative of risk-relevant behavioral patterns and psychological states. It also so prompts users to answer a daily check in question. Mobile sensing data are processed to provide an automated assessment of the user's functioning. Users will be asked to use Vira for 12 weeks.
The Vira app can be used as a standalone product. After an initial 10-day period, during which the app assesses the relationship between the user's patterns of behavior and their day-to-day variations in mental health and wellbeing using passive mobile sensing, the user is able to access a personalized behavior change goal that is support by in app information and functionality.
Group II: Vira + CoachingExperimental Treatment1 Intervention
The Vira app can also be supported by a health coach. The health coach interacts with the user (via an instant messaging platform) and who also schedules just-in-time reminders (i.e., "nudges") to arrive in the user's phone at scheduled times to support their behavior change plan. The Vira Health Coach Platform therefore integrates mobile sensing, self-report assessment, and just-in-time nudges and notifications into the coach's workflow.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vira mobile app intervention
2022
N/A
~80
Vira mobile app intervention + coaching
2022
N/A
~80
Find a Location
Who is running the clinical trial?
Novo Nordisk A/SIndustry Sponsor
1,557 Previous Clinical Trials
2,446,237 Total Patients Enrolled
Ksana HealthLead Sponsor
2 Previous Clinical Trials
220 Total Patients Enrolled
2 Trials studying Mental Health Disorders
220 Patients Enrolled for Mental Health Disorders
Nick Allen, PhDPrincipal InvestigatorKsana Health
1 Previous Clinical Trials
200 Total Patients Enrolled
1 Trials studying Mental Health Disorders
200 Patients Enrolled for Mental Health Disorders