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

A Randomized Controlled Trial of the Feasibility and Acceptability of W-GenZD Versus CBT-light Teletherapy for Adolescents Seeking Mental Health Services

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety
• Intervention / Treatment: Device: Woebot for Adolescents (W-GenZD) Mobile Application; Behavioral: CBT-Lite Teletherapy Group

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Children's Hospital of The King's Daughters

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: W-GenZD Mobile Application Group; 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; 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.
Active Comparator: CBT-Lite Teletherapy Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire, 8 Items (PHQ-8)	Measure of depression severity. An 8-item abbreviated version of the PHQ-9 used to assess depressive symptomatology over the past 2 weeks. The PHQ-8 excludes an item assessing suicidality. Items (e.g., "Over the last 2 weeks, how often have you been bothered by ... feeling down, depressed or hopeless?") are rated on a 4-point Likert scale (0 = "not at all" to 3 = "nearly every day"). Total scores range from 0-24, with higher scores indicating increased severity of depressive symptoms.	Baseline; end-of-treatment (4 weeks from baseline); change from baseline to end-of-treatment at 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Working Alliance Inventory-Short Revised (WAI-SR)	Measure of working alliance. A measure of therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Scores range from 5-20, with higher scores indicating greater alliance. The present study utilized the validated 12-item Short-Revised version (WAI-SR) with minor changes to language, replacing "therapist" with "Woebot" or "study group therapist" for participants randomized to the W-GenZD treatment arm or the CBT-light teletherapy treatment arm, respectively.	Difference between mid-treatment at 5 days within treatment and post-treatment at 4 weeks

Collaborators and Investigators

• Sponsor: Woebot Health
• Collaborators: Children's Hospital of The King's Daughters
• Investigators: Principal Investigator: Mary Margaret Gleason, MD, Children's Hospital of The King's Daughters

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2022
• Primary Completion (Actual): January 19, 2023
• Study Completion (Actual): February 16, 2023

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2024
• Last Update Submitted That Met QC Criteria: July 26, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Mental Health; Cognitive Behavioral Therapy; Adolescence; Digital Therapeutic; Chatbot; Mental Health App
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: W-GenZD-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No