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Feasibility and Acceptability of W-GenZD vs CBT-light Teletherapy for Adolescents Seeking Mental Health Services | Clinical Trials | Clareo Health

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Feasibility and Acceptability of W-GenZD vs CBT-light Teletherapy for Adolescents Seeking Mental Health Services

A Randomized Controlled Trial of the Feasibility and Acceptability of W-GenZD Versus CBT-light Teletherapy for Adolescents Seeking Mental Health Services

NCT05372913•Woebot Health

View on ClinicalTrials.gov

Summary

The primary aim of this study is to determine the feasibility and acceptability of the W-GenZD mobile application among a group of adolescents and who have screened and triaged into low-intensity treatment within the Children's Hospital of the King's Daughters. The secondary aim of this study is to determine the preliminary comparative efficacy of W-GenZD and CBT-light teletherapy zoom groups to manage mood concerns at 4-weeks end of treatment relative to baseline. The third aim of this study is to investigate potential differences between group differences on working alliance. An exploratory aim of this study is to observe and describe the utilization and outcomes of the safety procedures utilized within this study.

Eligibility

Age

13 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Have completed triage at the Children's Hospital of the King's Daughters (CHKD) and have been deemed appropriate for the low-intensity intervention track, given presenting problem(s) of depressive or anxiety symptoms
•2. Adolescent 13-17 years of age, inclusive
•3. U.S. resident
•4. Both adolescent participant and parent/guardian are able to read and write in English
•5. Own or have regular access to a smartphone (Android or iOS smartphone with a recent, supported operating system), that can receive SMS messages, and reliable Wi-Fi access or sufficient data to engage with assigned treatment condition for the duration of the study
•6. If currently prescribed antidepressant medications (e.g. escitalopram/Lexapro, fluoxetine/ Prozac), antipsychotic medications (e.g. aripiprazole, asenapine, olanzapine, paliperidone, quetiapine, risperidone), or stimulants (e.g. amphetamine/Adderall, Methylphenidate/Ritalin) and alpha agonists (e.g. atomoxetine/Strattera, Guanfacine/Intuniv) they are at a regular, stable dose for at least 60 days at screening
•7. Not currently actively engaged is psychotherapy
•8. Available and committed to engage with the program and complete assessments for a 8-week duration
•9. Family is willing and able to engage in discussion of safety planning in the event of suicidal symptoms

Exclusion Criteria

•1. Lifetime diagnosis of a psychotic disorder (including schizophrenia or schizoaffective disorder)
•2. Lifetime diagnosis of bipolar disorder
•3. Lifetime diagnosis of autism spectrum disorder or pervasive developmental disorder (e.g. autism, Asperger syndrome, Rett's syndrome)
•4. Current diagnosis of developmental delay or intellectual disability
•5. Suicidal ideation with a plan or intent or a suicidal attempt within the past 12 months
•6. History of (a) drug and/or alcohol abuse within the past 12 months
•7. Current use of benzodiazepines (e.g. lorazepam, clonazepam, alprazolam, diazepam, triazolam) or certain sleep aids (zolpidem, eszopiclone, zaleplon)
•8. Previous Woebot application use
•9. Enrollment of more than one member of the same household

Locations (1)

Children's Hospital of The King's Daughters

Norfolk, Virginia, United States

Key Dates

Start Date

May 11, 2022

Primary Completion Date

January 19, 2023

Completion Date

February 16, 2023

Last Updated

October 17, 2024

Enrollment

141

ACTUAL participants

Conditions

DepressionAnxiety

Interventions

Woebot for Adolescents (W-GenZD) Mobile Application

DEVICE

CBT-Lite Teletherapy Group

BEHAVIORAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 17, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Feasibility and Acceptability of W-GenZD vs CBT-light Teletherapy for Adolescents Seeking Mental Health Services

Inclusion Criteria

Exclusion Criteria

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