Skip to main content
OpenTrials
Completed

NCT Number: NCT05372913

Feasibility and Acceptability of W-GenZD vs 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders Personal Satisfaction Psychological Well-Being

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of The King's Daughters

Norfolk, Virginia, 23507, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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 outcomes

  1. Patient Health Questionnaire, 8 Items (PHQ-8)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Woebot Health

Industry

Collaborators

  • Children's Hospital of The King's Daughters

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 13, 2022
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.