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

N/A

Waitlist Available

Led By Mary Margaret Gleason, MD

Research Sponsored by Woebot Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; end-of-treatment (4 weeks from baseline); change from baseline to end-of-treatment at 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new mobile app and online group therapy for teenagers with mild mood issues. The goal is to see if these tools help them feel better by managing their feelings and thoughts.

Eligible Conditions

Depression
Botox

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; end-of-treatment (4 weeks from baseline); change from baseline to end-of-treatment at 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; end-of-treatment (4 weeks from baseline); change from baseline to end-of-treatment at 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; end-of-treatment (4 weeks from baseline); change from baseline to end-of-treatment at 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Usage Rating Profile-Intervention Revised (URP-IR), Acceptability Subscale

Usage Rating Profile-Intervention Revised (URP-IR), Feasibility Subscale

Secondary study objectives

Patient Health Questionnaire, 8 Items (PHQ-8)

Other study objectives

Working Alliance Inventory-Short Revised (WAI-SR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: W-GenZD Mobile Application GroupExperimental Treatment1 Intervention

Participants assigned to the W-GenZD mobile application group will be asked to download and use the W-GenZD mobile application that will provide information and tools through a chatbot (a computer program designed to communicate with users). Participants will be invited to use the mobile application as often as they like during the 4-week treatment period - we will encourage 5 to 10 minutes of daily use.

Group II: CBT-Lite Teletherapy GroupActive Control1 Intervention

Participants assigned to the CBT-lite teletherapy group will be asked to attend 1-hour teletherapy group sessions over Zoom once a week for 4 weeks. In this group, a study clinician will cover topics such as building a coping tool box, accepting your feelings, challenging negative thoughts, and problem solving.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Woebot for Adolescents (W-GenZD) Mobile Application

2022

N/A

~150

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