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Vira Self-Care for Mental Health Disorders

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

Study Summary

This trial tests a mobile app and health coaching program to help reduce depression and improve weight in 18-25 year olds, with or without family history of obesity.

Eligible Conditions
  • Mental Health Disorders
  • Obesity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more

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
1,515 Previous Clinical Trials
2,415,339 Total Patients Enrolled
Ksana HealthLead Sponsor
1 Previous Clinical Trials
200 Total Patients Enrolled
1 Trials studying Mental Health Disorders
200 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the criteria for this research study inclusive of individuals aged fifty and over?

"According to the stated inclusion criteria, only individuals between 18-25 years of age may participate in this trial."

Answered by AI

Who is the optimal participant for this trial?

"This clinical trial is aiming to enrol 100 individuals of ages 18-25 that have been diagnosed with obesity."

Answered by AI

How many people have been recruited to partake in this research venture?

"Affirmative. According to clinicaltrials.gov, this scientific inquiry is presently looking for participants; it was first posted on the 7th of November 2022 and updated most recently on the 6th of December 2022. It seeks to recruit 100 patients from a single location."

Answered by AI

Is this medical research project currently recruiting volunteers?

"Affirmative. The details hosted on clinicaltrials.gov demonstrate that this medical trial is actively recruiting individuals as of December 6th 2022; the study was first posted on November 7th, with a goal to recruit 100 patients from 1 site."

Answered by AI

Who else is applying?

What state do they live in?
Oklahoma
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I haven't been taking care of my mental health and avoided seeing doctors for awhile. My mother suggested this to me.
PatientReceived 1 prior treatment
~29 spots leftby May 2025