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

NCT05372913 | Completed Results

• 1 other identifier: W-GenZD-003
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Depression; Anxiety

Keywords

Mental Health; Adolescence; Digital Therapeutic; Cognitive Behavioral Therapy; Chatbot; Mental Health App

Outcome Measures

Primary Outcomes (2)

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

  Measure of feasibility. A 6-item subscale that inquires about factors that impact treatment usage (i.e., intervention quality). Items (e.g., "The total time required to do the treatment procedures was manageable") are rated on a 6-point Likert scale (1 = "strongly disagree" to 6 = "strongly agree"). Total feasibility scores range from 6-36, with higher scores indicating greater intervention feasibility with the W-GenZD mobile application or the CBT-Lite teletherapy groups.

  End-of-treatment (4 weeks from baseline)

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

  Measure of acceptability. A 9-item subscale that inquires about intervention acceptability. For the purposes of this study, an adapted 6-item version of the subscale was utilized. Items (e.g., "This treatment is an effective choice for addressing a variety of depression concerns) are rated on a 6-point Likert scale (1 = "strongly disagree" to 6 = "strongly agree"). Total acceptability scores range from 6-36, with higher scores indicating greater intervention acceptability with the W-GenZD mobile application or the CBT-Lite teletherapy groups.

  End-of-treatment (4 weeks from baseline)

Secondary Outcomes (1)

• Patient Health Questionnaire, 8 Items (PHQ-8)

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

Study Arms (2)

W-GenZD Mobile Application Group

EXPERIMENTAL

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.

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

CBT-Lite Teletherapy Group

ACTIVE COMPARATOR

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.

Behavioral: CBT-Lite Teletherapy Group

Interventions

Woebot for Adolescents (W-GenZD) Mobile Application DEVICE

Woebot for Adolescents (W-GenZD) is a mobile application program that delivers evidence-based therapy for the symptoms of mild-moderate depression and anxiety in adolescents in brief "conversations" with a fully automated relational agent called Woebot. It is a brief, self-guided 4 week-intervention that draws from cognitive behavioral therapy (CBT), interpersonal psychotherapy for adolescents (IPT-A), and elements of dialectical behavior therapy (DBT), depending on the presenting situation, to help the adolescent develop emotion regulation skills in the context of their everyday life. In this way, the mobile application is designed to be targeted, relevant, and integrated into the lived experience of adolescents, capable of delivering the appropriate technique for the problem at hand, at the time of need.

W-GenZD Mobile Application Group

CBT-Lite Teletherapy Group BEHAVIORAL

The CBT-Lite teletherapy group is a brief, 4-week intervention held once weekly for an hour, and limited to those triaged into the Children's Hospital of the King's Daughters low-intensity track and participating in this protocol. An assigned study clinician will facilitate each teletherapy group with approximately 10 adolescents in each session. Each group begins with orientation and reviewing group rules, individual check-ins with each participant (rating stress level and hopefulness), followed by a guided mindfulness moment. Sessions are designed to draw from elements of cognitive behavioral therapy (CBT) and the 4 topics include: building a coping tool box, accepting your feelings, challenging negative thoughts, and problem solving.

CBT-Lite Teletherapy Group

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Woebot Health: lead
• Children's Hospital of The King's Daughters: collaborator

Study Sites (1)

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507, United States

Location

Related Publications (2)

• Gleason MM, Flom M, Rapoport S, Williams A, Birch A, Wells NK, Forman-Hoffman V, Robinson A. A Relational Agent Intervention for Adolescents Seeking Mental Health Treatment: Outcomes From a Randomized Controlled Trial Within a Children's Outpatient Hospital. JAACAP Open. 2025 Feb 11;3(4):1033-1045. doi: 10.1016/j.jaacop.2025.02.002. eCollection 2025 Dec.

  PMID: 41367963 DERIVED

• Chiauzzi E, Robinson A, Martin K, Petersen C, Wells N, Williams A, Gleason MM. A Relational Agent Intervention for Adolescents Seeking Mental Health Treatment: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Mar 3;12:e44940. doi: 10.2196/44940.

  PMID: 36867455 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Results Point of Contact

• Title: Dr. Athena Robinson
• Organization: Woebot Health

athena@woebothealth.com

(415) 209-5642

Study Officials

• Mary Margaret Gleason, MD

  Children's Hospital of The King's Daughters

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 13, 2022
• Study Start: May 11, 2022
• Primary Completion: January 19, 2023
• Study Completion: February 16, 2023
• Last Updated: October 17, 2024
• Results First Posted: October 17, 2024

Record last verified: 2024-07

Locations

US (1)