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W-GenZD Mobile Application for Anxiety

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
U.S. resident
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights

Study Summary

This trial is testing a new mobile app to help adolescents with low-intensity treatment for mood concerns. The goal is to see if the app is feasible and acceptable, and if it's better than CBT-light teletherapy zoom groups. Researchers will also look at how well the app works with the safety procedures in place.

Eligible Conditions
  • Anxiety
  • Depression

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Client Satisfaction Questionnaire (CSQ-8)
Content satisfaction ratings in the W-GenZD application
Number of CBT-light teletherapy group sessions attended
+7 more
Secondary outcome measures
Generalized Anxiety Disorder Questionnaire (GAD-7)
Mood and Feeling Questionnaire (MFQ)
Patient Health Questionnaire for Teens (PHQ-8)
Other outcome measures
Working Alliance Inventory-Short Revised (WAI-SR)

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-Light Teletherapy GroupActive Control1 Intervention
Participants assigned to the CBT-light 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
W-GenZD Mobile Application
2022
N/A
~150

Find a Location

Who is running the clinical trial?

Woebot HealthLead Sponsor
13 Previous Clinical Trials
1,972 Total Patients Enrolled
Woebot Labs, Inc.Lead Sponsor
6 Previous Clinical Trials
638 Total Patients Enrolled
Children's Hospital of The King's DaughtersOTHER
12 Previous Clinical Trials
1,784 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrolment rate for this clinical trial?

"Affirmative. Clinicaltrials.gov reveals that this clinical trial opened for recruitment on May 11th 2022, and is still seeking patients at the time of writing. This endeavor requires 260 participants to be sourced from 1 designated medical facility."

Answered by AI

Are there any unfilled slots for participants in this research project?

"According to the data housed on clinicaltrials.gov, this medical trial is actively seeking enrolment; it was originally posted on May 11th 2022 and last updated December 7th 2022."

Answered by AI

Are there any prerequisites for enrolling in this research project?

"This clinical trial requires the recruitment of 260 adolescents between 13 and 17 who are suffering from depression. In addition to this, participants must have been approved for low-intensity intervention at CHKD, be a US resident with basic English literacy skills, not actively engage in psychotherapy sessions, commit to 8 weeks' worth of assessments and conversations on safety planning if necessary, possess or access an Android/iOS smartphone with recent OS version that is capable of receiving SMS messages as well as having reliable Wi-Fi connection or sufficient data plan."

Answered by AI

Are persons who are over 30 years old eligible to participate in this medical experiment?

"Qualified patients for this trial must be within the age range of 13 to 17 years old. There are 220 trials specifically targeting minors and 994 clinical studies that focus on individuals over 65."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
How old are they?
18 - 65
What site did they apply to?
Children's Hospital of The King's Daughters
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Feasibility and Acceptability of W-GenZD vs CBT-light Teletherapy for Adolescents Seeking Mental Health Services
2022. "Feasibility and Acceptability of W-GenZD vs CBT-light Teletherapy for Adolescents Seeking Mental Health Services". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05372913.
~48 spots leftby Apr 2025
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