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

Not Applicable

Completed

Interventions: Device: W-GenZD Mobile Application
Behavioral: CBT-Light Teletherapy

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
W-GenZD Mobile Application Group	W-GenZD Mobile Application	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.
CBT-Light Teletherapy Group	CBT-Light Teletherapy	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.

Primary Outcome Measures

Name	Time	Method
Usage Rating Profile-Intervention Revised (URP-IR), Feasibility Subscale	End-of-treatment (4 weeks from baseline)	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.
Usage Rating Profile-Intervention Revised (URP-IR), Acceptability Subscale	End-of-treatment (4 weeks from baseline)	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.

Secondary Outcome Measures

Name	Time	Method
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	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.