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Behavioral Intervention

Digitally enhanced treatment supported by the Vira platform for Mental Health Disorders

N/A

Recruiting

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 younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 and 6 months

Awards & highlights

Study Summary

This trial aims to use digital tools, like smartphones, to help prevent suicide among young people by collecting data on risk factors such as psychological distress and sleep disturbance. The goal is to create a digital platform

Who is the study for?

This trial is for English-speaking teens aged 13-18 who are at high risk for suicide and currently receiving treatment in the Intensive Adolescent and Family DBT Program. They must own a smartphone (Android or iPhone 7+) and have consent from guardians if under 18.Check my eligibility

What is being tested?

The study is testing 'Vira', a digital platform designed to help healthcare providers manage youth at risk of suicide by using mobile data and secure communication tools, compared with the usual treatment methods.See study design

What are the potential side effects?

Since this trial involves a digital platform rather than medication, traditional side effects aren't expected. However, there may be privacy concerns or emotional distress related to discussing sensitive topics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Columbia Suicide Severity Rating Scale (C-SSRS)

Scale for Suicidal Ideation (SSI)

Secondary outcome measures

Anticipatory & Consummatory Interpersonal Pleasure Scale (ACIPS)

Mood and Feelings Questionnaire (MFQ)

Pittsburgh Sleep Quality Index (PSQI)

+2 more

Other outcome measures

Interpersonal Needs Questionnaire (INQ)

National Institute of Drug Abuse (NIDA) Quick Screen V1.0

System Usability Scale (SUS)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Digitally enhanced treatment supported by the Vira platformExperimental Treatment1 Intervention

Intensive outpatient DBT supported by the Vira platform. The Vira app is installed on the patient's smartphone. 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 prompts users to answer a daily check in question. Mobile sensing data are processed to provide an automated assessment of the user's functioning. Patients will be asked to use Vira for the duration of their intensive outpatient treatment. Patients' use of the Vira app is supported by practitioners, who can schedule just-in-time reminders (i.e., "nudges") to arrive in the user's phone at scheduled times to support their behavior change plan and DBT treatment. The Vira Platform therefore integrates mobile sensing, self-report assessment, and just-in-time nudges and notifications into the practitioner's workflow.

Group II: Treatment as Usual (TAU)Active Control1 Intervention

Intensive outpatient DBT + EARS app (passive data monitoring software)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteOTHER

475 Previous Clinical Trials

153,707 Total Patients Enrolled

3 Trials studying Mental Health Disorders

4,014 Patients Enrolled for Mental Health Disorders

Columbia UniversityOTHER

1,433 Previous Clinical Trials

2,447,609 Total Patients Enrolled

1 Trials studying Mental Health Disorders

2,000 Patients Enrolled for Mental Health Disorders

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,509 Total Patients Enrolled

8 Trials studying Mental Health Disorders

4,078 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 enrollment for this research study currently open and accepting participants?

"Yes, as per details on clinicaltrials.gov, this trial is actively pursuing participants. The trial was initially listed on April 7th, 2024 and the most recent revision occurred on March 26th, 2024. Recruitment aims to enroll a total of 200 individuals from one designated site."

Answered by AI

What is the current number of subjects participating in this investigation?

"Affirmative. Information available on clinicaltrials.gov reveals that this medical investigation is actively pursuing potential participants. Originally posted on April 7, 2024, and last modified on March 26, 2024, the trial aims to enroll 200 patients at a single site."

Answered by AI

Is there an age restriction for individuals participating in this clinical study, specifically regarding those older than 30 years?

"This clinical investigation is seeking participants aged 13 to under 18 years."

Answered by AI

What are the principal goals that this medical study aims to achieve?

"As per Ksana Health, the main focus of this trial is evaluating Scale for Suicidal Ideation (SSI) over a 6-month timeframe. Secondary assessments will also include Pittsburgh Sleep Quality Index (PSQI), which gauges sleep quality with total scores ranging from 0 to 21 and higher numbers indicating poorer sleep; Mood and Feelings Questionnaire (MFQ) used in young people to assess depressive symptoms, where higher scores indicate more severe depression on a scale from 0 to 26; as well as Screen for Anxiety Related Emotional Disorders (SCARED), assessing childhood anxiety disorders with total scores ranging from 0"

Answered by AI

Do I meet the qualifications to participate in this research endeavor?

"The research project is seeking 200 individuals aged between 13 and 18 experiencing anhedonia. Of particular importance, candidates must fulfil the subsequent conditions: Obtain written assent from minors aged 13-17 years along with parental permission or consent for those who are 18; Currently undergoing treatment at the Intensive Adolescent and Family DBT Program; Aged between 13 to 18 years old; Possess a personal smartphone compatible with Android or iPhone models starting from version 7+; Proficient in English language."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Digitally Assisted Risk Reduction Platform for Youth at High Risk for Suicide

2024. "A Digitally Assisted Risk Reduction Platform for Youth at High Risk for Suicide". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05920252.