CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 141 enrolled
Drug / intervention
Woebot for Adolescents (W-GenZD) Mobile Application +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05372913
NCT05372913N/ACompleted

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

Woebot Health·interventional·Posted May 13, 2022·Updated Oct 17, 2024

In Brief

A clinical study evaluating Woebot for Adolescents (W-GenZD) Mobile Application and CBT-Lite Teletherapy Group for Depression and Anxiety. Completed, enrolled 141 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression, Anxiety
CountriesUnited States

Timeline

N/ACompletedFinished
2023202420252026
First PostedMay 13, 2022
Enrollment StartMay 11, 2022
Primary CompletionJan 19, 2023
Study CompletionFeb 16, 2023
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 4.1 years ago

Interventions

Woebot for Adolescents (W-GenZD) Mobile Applicationdevice

Woebot for Adolescents (W-GenZD) is a mobile application program that delivers evidence-based therapy for the symptoms of mild-moderate depression and anxiety in adolescents in brief "conversations" with a fully automated relational agent called Woebot. It is a brief, self-guided 4 week-intervention that draws from cognitive behavioral therapy (CBT), interpersonal psychotherapy for adolescents (IPT-A), and elements of dialectical behavior therapy (DBT), depending on the presenting situation, to help the adolescent develop emotion regulation skills in the context of their everyday life. In this way, the mobile application is designed to be targeted, relevant, and integrated into the lived experience of adolescents, capable of delivering the appropriate technique for the problem at hand, at the time of need.

CBT-Lite Teletherapy Groupbehavioral

The CBT-Lite teletherapy group is a brief, 4-week intervention held once weekly for an hour, and limited to those triaged into the Children's Hospital of the King's Daughters low-intensity track and participating in this protocol. An assigned study clinician will facilitate each teletherapy group with approximately 10 adolescents in each session. Each group begins with orientation and reviewing group rules, individual check-ins with each participant (rating stress level and hopefulness), followed by a guided mindfulness moment. Sessions are designed to draw from elements of cognitive behavioral therapy (CBT) and the 4 topics include: building a coping tool box, accepting your feelings, challenging negative thoughts, and problem solving.