W-GenZD Mobile Application for Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Children's Hospital of The King's Daughters, Norfolk, VA
Depression+1 More
W-GenZD Mobile Application - Device
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Depression
  • Anxiety

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

10 Primary · 3 Secondary · Reporting Duration: Change from Baseline to Mid-Treatment at 2 weeks; Change from Baseline to Post-Treatment at 4 weeks; Change from Baseline to Follow-Up at 8 weeks)

Week 8
Patient Health Questionnaire for Teens (PHQ-8)
Week 8
Generalized Anxiety Disorder Questionnaire (GAD-7)
Mood and Feeling Questionnaire (MFQ)
Week 4
Working Alliance Inventory-Short Revised (WAI-SR)
Week 4
Client Satisfaction Questionnaire (CSQ-8)
Satisfaction Questionnaire
Usage Rating Profile Intervention (URPI)-Acceptability
Usage Rating Profile Intervention (URPI)-Feasibility
Week 4
Content satisfaction ratings in the W-GenZD application
Number of CBT-light teletherapy group sessions attended
Number of active days in the W-GenZD application
Number of active minutes in the W-GenZD application
Number of messages sent per week in the W-GenZD application
Number of modules completed in the W-GenZD application

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

CBT-Light Teletherapy Group
1 of 2
W-GenZD Mobile Application Group
1 of 2
Active Control
Experimental Treatment

260 Total Participants · 2 Treatment Groups

Primary Treatment: W-GenZD Mobile Application · No Placebo Group · N/A

W-GenZD Mobile Application Group
Device
Experimental Group · 1 Intervention: W-GenZD Mobile Application · Intervention Types: Device
CBT-Light Teletherapy Group
Behavioral
ActiveComparator Group · 1 Intervention: CBT-Light Teletherapy · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline to mid-treatment at 2 weeks; change from baseline to post-treatment at 4 weeks; change from baseline to follow-up at 8 weeks)
Closest Location: Children's Hospital of The King's Daughters · Norfolk, VA
Photo of virginia 1Photo of virginia 2Photo of virginia 3
2012First Recorded Clinical Trial
1 TrialsResearching Depression
52 CompletedClinical Trials

Who is running the clinical trial?

Children's Hospital of The King's DaughtersOTHER
10 Previous Clinical Trials
1,494 Total Patients Enrolled
Woebot Labs, Inc.Lead Sponsor
6 Previous Clinical Trials
1,251 Total Patients Enrolled
3 Trials studying Depression
730 Patients Enrolled for Depression
Mary Margaret Gleason, MDPrincipal InvestigatorChildren's Hospital of The King's Daughters

Eligibility Criteria

Age < 18 · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are currently taking one or more of the following medications: antidepressants, antipsychotics, stimulants, or alpha agonists.
You are not currently engaged in psychotherapy.
You are available and committed to complete the program and assessments for a 8-week duration.
The family is willing and able to engage in discussion of safety planning in the event of suicidal symptoms.
You have a smartphone 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.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.