NCT05372913

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Woebot Health · Industry
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression
• Anxiety

Interventions

Type	Name	Description
DEVICE	Woebot for Adolescents (W-GenZD) Mobile Application	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.
BEHAVIORAL	CBT-Lite Teletherapy Group	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.

Timeline

• Start date: 2022-05-11
• Primary completion: 2023-01-19
• Completion: 2023-02-16
• First posted: 2022-05-13
• Last updated: 2024-10-17
• Results posted: 2024-10-17

Locations

1 site across 1 country: United States