Status:
COMPLETED
Feasibility and Acceptability of W-GenZD vs CBT-light Teletherapy for Adolescents Seeking Mental Health Services
Lead Sponsor:
Woebot Health
Collaborating Sponsors:
Children's Hospital of The King's Daughters
Conditions:
Depression
Anxiety
Eligibility:
All Genders
13-17 years
Phase:
NA
Brief 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 trea...
Eligibility Criteria
Inclusion
- 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
- Adolescent 13-17 years of age, inclusive
- U.S. resident
- Both adolescent participant and parent/guardian are able to read and write in English
- Own or have regular access to a smartphone (Android or iOS smartphone with a recent, supported operating system), 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
- If currently prescribed antidepressant medications (e.g. escitalopram/Lexapro, fluoxetine/ Prozac), antipsychotic medications (e.g. aripiprazole, asenapine, olanzapine, paliperidone, quetiapine, risperidone), or stimulants (e.g. amphetamine/Adderall, Methylphenidate/Ritalin) and alpha agonists (e.g. atomoxetine/Strattera, Guanfacine/Intuniv) they are at a regular, stable dose for at least 60 days at screening
- Not currently actively engaged is psychotherapy
- Available and committed to engage with the program and complete assessments for a 8-week duration
- Family is willing and able to engage in discussion of safety planning in the event of suicidal symptoms
Exclusion
- Lifetime diagnosis of a psychotic disorder (including schizophrenia or schizoaffective disorder)
- Lifetime diagnosis of bipolar disorder
- Lifetime diagnosis of autism spectrum disorder or pervasive developmental disorder (e.g. autism, Asperger syndrome, Rett's syndrome)
- Current diagnosis of developmental delay or intellectual disability
- Suicidal ideation with a plan or intent or a suicidal attempt within the past 12 months
- History of (a) drug and/or alcohol abuse within the past 12 months
- Current use of benzodiazepines (e.g. lorazepam, clonazepam, alprazolam, diazepam, triazolam) or certain sleep aids (zolpidem, eszopiclone, zaleplon)
- Previous Woebot application use
- Enrollment of more than one member of the same household
Key Trial Info
Start Date :
May 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2023
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT05372913
Start Date
May 11 2022
End Date
February 16 2023
Last Update
October 17 2024
Active Locations (1)
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1
Children's Hospital of The King's Daughters
Norfolk, Virginia, United States, 23507