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

Woebot Health

Status: Completed

Conditions: Depression; Anxiety

Treatments: Behavioral: CBT-Lite Teletherapy Group; Device: Woebot for Adolescents (W-GenZD) Mobile Application

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05372913

W-GenZD-003

Details and patient eligibility

About

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.

Enrollment: 141 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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
2. Adolescent 13-17 years of age, inclusive
3. U.S. resident
4. Both adolescent participant and parent/guardian are able to read and write in English
5. 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
6. 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
7. Not currently actively engaged is psychotherapy
8. Available and committed to engage with the program and complete assessments for a 8-week duration
9. Family is willing and able to engage in discussion of safety planning in the event of suicidal symptoms

Exclusion criteria

1. Lifetime diagnosis of a psychotic disorder (including schizophrenia or schizoaffective disorder)
2. Lifetime diagnosis of bipolar disorder
3. Lifetime diagnosis of autism spectrum disorder or pervasive developmental disorder (e.g. autism, Asperger syndrome, Rett's syndrome)
4. Current diagnosis of developmental delay or intellectual disability
5. Suicidal ideation with a plan or intent or a suicidal attempt within the past 12 months
6. History of (a) drug and/or alcohol abuse within the past 12 months
7. Current use of benzodiazepines (e.g. lorazepam, clonazepam, alprazolam, diazepam, triazolam) or certain sleep aids (zolpidem, eszopiclone, zaleplon)
8. Previous Woebot application use
9. Enrollment of more than one member of the same household

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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141 participants in 2 patient groups

W-GenZD Mobile Application Group

Experimental group

Description:

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.

Treatment:

Device: Woebot for Adolescents (W-GenZD) Mobile Application

CBT-Lite Teletherapy Group

Active Comparator group

Description:

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:

Behavioral: CBT-Lite Teletherapy Group