Clinical trial NCT05372913: Feasibility and Acceptability of W-GenZD vs CBT-light Teletherapy for Adolescents Seeking Mental Health Services
Official title: A Randomized Controlled Trial of the Feasibility and Acceptability of W-GenZD Versus CBT-light Teletherapy for Adolescents Seeking Mental Health Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Keywords: Mental Health
Adolescence
Digital Therapeutic
Cognitive Behavioral Therapy
Chatbot
Mental Health App
Lead sponsor: Woebot Health
Sponsor class: INDUSTRY
Collaborators: name: Children's Hospital of The King's Daughters
First posted: 2022-05-13
Enrollment: 141
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Usage Rating Profile-Intervention Revised (URP-IR), Feasibility Subscale
timeFrame: End-of-treatment (4 weeks from baseline)
measure: Usage Rating Profile-Intervention Revised (URP-IR), Acceptability Subscale
timeFrame: End-of-treatment (4 weeks from baseline)
Secondary outcomes:
measure: Patient Health Questionnaire, 8 Items (PHQ-8)
timeFrame: Baseline; end-of-treatment (4 weeks from baseline); change from baseline to end-of-treatment at 4 weeks
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Children's Hospital of The King's Daughters
state: Virginia
Study officials:
affiliation: Children's Hospital of The King's Daughters
name: Mary Margaret Gleason, MD
role: PRINCIPAL_INVESTIGATOR
References: