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

Study Overview
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Brief Summary
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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.

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

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Device: W-GenZD Mobile Application
* Behavioral: CBT-Light Teletherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: W-GenZD Mobile Application Group<br>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: W-GenZD Mobile Application<br>* 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.<br>|
| Active Comparator: CBT-Light Teletherapy Group<br>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. | Behavioral: CBT-Light Teletherapy<br>* The CBT-Light 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usage Rating Profile Intervention (URPI)-Feasibility | Measure of feasibility. A 6-item subscale that inquires about factors that impact treatment usage (i.e., intervention quality). Responses range from 1 = slightly disagree to 6 = strongly agree. Scores are averages, with greater scores indicating greater intervention feasibility. | End of treatment (4 weeks from baseline) | 
| Usage Rating Profile Intervention (URPI)-Acceptability | Measure of acceptability. A 6-item subscale that inquires about intervention acceptability. Responses range from 1 = slightly disagree to 6 = strongly agree. Scores are averages, with greater scores indicating greater intervention acceptability. | End of treatment (4 weeks from baseline) | 
| Client Satisfaction Questionnaire (CSQ-8) | An 8-item measure used to assess client's satisfaction with treatment on a 4-point scale (1 = very dissatisfied to 4 = very satisfied). Example questions include, How would you rate the quality of service you received? and Did you get the kind of service you wanted? Total sums range from 8-32, with high scores indicating greater satisfaction with the W-GenZD mobile application or the CBT-light teletherapy groups. | End of treatment (4 weeks from baseline) | 
| Satisfaction Questionnaire | 3 open-ended questions asking participants in the W-GenZD-003 treatment arm what they found most helpful about the W-GenZD mobile application, what would make it better, and if there is any other feedback they would like to share. | End of treatment (4 weeks from baseline) | 
| Number of CBT-light teletherapy group sessions attended | Group engagement in the total number of sessions attended will be collected during the study to provide quantitative data regarding CBT-light group attendance. | Throughout treatment (from baseline to post-treatment at 4 weeks) | 
| Number of active days in the W-GenZD application | Application engagement in the total number of active days using the application will be collected during the study to provide quantitative data regarding application utilization. | Throughout treatment (from baseline to post-treatment at 4 weeks) | 
| Number of active minutes in the W-GenZD application | Application engagement in the total number of active minutes using the application will be collected during the study to provide quantitative data regarding application utilization. | Throughout treatment (from baseline to post-treatment at 4 weeks) | 
| Number of messages sent per week in the W-GenZD application | Application engagement in the number of messages sent each week within the application will be collected during the study to provide quantitative data regarding application utilization. | Throughout treatment (from baseline to post-treatment at 4 weeks) | 
| Number of modules completed in the W-GenZD application | Application engagement in the number of modules completed within the application will be collected during the study to provide quantitative data regarding application content engagement. | Throughout treatment (from baseline to post-treatment at 4 weeks) | 
| Content satisfaction ratings in the W-GenZD application | Application content satisfaction ratings will be collected during the study to provide quantitative data regarding application content engagement. | Throughout treatment (from baseline to post-treatment at 4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire for Teens (PHQ-8) | Measure of depression severity. An 8-item abbreviated version of the PHQ-9 used to assess mood and anxiety symptoms respectively. The PHQ-8 excludes an item assessing suicidality. Total score between 0-27, where higher scores indicate greater levels of depression. | 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) | 
| Generalized Anxiety Disorder Questionnaire (GAD-7) | Measure of anxiety. A 7-item brief self-report measure used to assess the frequency and severity of anxious thoughts and behaviors over the past 2 weeks. Total score between 0-21, where higher scores indicate greater levels of anxiety. | Change from Baseline to Post-Treatment at 4 weeks; Change from Baseline to Follow-Up at 8 weeks) | 
| Mood and Feeling Questionnaire (MFQ) | Measure of mood. A child self-report assessment consisting of 13 descriptive phrases related to the participant's recent feelings and behaviors. Respondents reflect on whether the phrases are true, sometimes true, or not true of the subject's feelings and behaviors during the past 2 weeks. | Change from Baseline to Post-Treatment at 4 weeks; Change from Baseline to Follow-Up at 8 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mental Health, Adolescence, Digital Therapeutic, Cognitive Behavioral Therapy, Chatbot, Mental Health App