DepressionNCT05372913
Feasibility and Acceptability of W-GenZD vs CBT-light Teletherapy for Adolescents Seeking Mental Health Services
A study testing Woebot for Adolescents (W-GenZD) Mobile Application and CBT-Lite Teletherapy Group in people with Depression and Anxiety, run by Woebot Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Woebot for Adolescents (W-GenZD) Mobile Application and CBT-Lite Teletherapy Group
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2022to 16 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
About this study
Official title: 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.
- Conditions
- Depression, Anxiety
- Being tested
- Woebot for Adolescents (W-GenZD) Mobile Application, CBT-Lite Teletherapy Group
- Keywords
- Mental Health, Adolescence, Digital Therapeutic, Cognitive Behavioral Therapy, Chatbot, Mental Health App
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Woebot for Adolescents (W-GenZD) Mobile ApplicationDevice
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| W-GenZD Mobile Application Group | Experimental | 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. Receives: Device: Woebot for Adolescents (W-GenZD) Mobile Application |
| CBT-Lite Teletherapy Group | Active comparator | 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. Receives: Behavioral: CBT-Lite Teletherapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: End-of-treatment (4 weeks from baseline)
Secondary outcomes (1)
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.
Measured: Baseline; end-of-treatment (4 weeks from baseline); change from baseline to end-of-treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start11 May 2022
- Primary completion19 Jan 2023
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woebot Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital of The King's Daughters
- Responsible party
- Sponsor
- Investigators
- Mary Margaret Gleason, MD, Principal investigator, Children's Hospital of The King's Daughters
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05372913
- Sponsor's protocol ID
- W-GenZD-003
- Status last verified
- Jul 2024
- First submitted
- 29 Apr 2022
- Last updated
- 17 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gleason MM, Flom M, Rapoport S, Williams A, Birch A, Wells NK, Forman-Hoffman V, Robinson A. A Relational Agent Intervention for Adolescents Seeking Mental Health Treatment: Outcomes From a Randomized Controlled Trial Within a Children's Outpatient Hospital. JAACAP Open. 2025 Feb 11;3(4):1033-1045. doi: 10.1016/j.jaacop.2025.02.002. eCollection 2025 Dec.
PubMed 41367963Chiauzzi E, Robinson A, Martin K, Petersen C, Wells N, Williams A, Gleason MM. A Relational Agent Intervention for Adolescents Seeking Mental Health Treatment: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Mar 3;12:e44940. doi: 10.2196/44940.
PubMed 36867455
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Feasibility and Acceptability of W-GenZD Versus CBT-light Teletherapy for Adolescents Seeking Mental Health Services
- ClinicalTrials.gov ID
- NCT05372913
- Acronym / sponsor ID
- W-GenZD-003
- Conditions
- Depression, Anxiety
- Keywords
- Mental Health, Adolescence, Digital Therapeutic, Cognitive Behavioral Therapy, Chatbot, Mental Health App
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Woebot HealthIndustry (pharma, biotech, devices)
- Collaborators
- Children's Hospital of The King's Daughters
- Study start
- 11 May 2022 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 13 May 2022 (actual)
- Results
- Posted 17 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| W-GenZD Mobile Application Group | Experimental | Device: Woebot for Adolescents (W-GenZD) Mobile ApplicationParticipants 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-Lite Teletherapy Group | Active comparator | Behavioral: CBT-Lite Teletherapy GroupParticipants 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Woebot for Adolescents (W-GenZD) Mobile ApplicationWoebot 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. | Device | W-GenZD Mobile Application Group |
| CBT-Lite Teletherapy GroupThe 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. | Behavioural | CBT-Lite Teletherapy Group |
Primary outcome
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.
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41367963Gleason MM, Flom M, Rapoport S, Williams A, Birch A, Wells NK, Forman-Hoffman V, Robinson A. A Relational Agent Intervention for Adolescents Seeking Mental Health Treatment: Outcomes From a Randomized Controlled Trial Within a Children's Outpatient Hospital. JAACAP Open. 2025 Feb 11;3(4):1033-1045. doi: 10.1016/j.jaacop.2025.02.002. eCollection 2025 Dec.
- Derived from this study: PubMed 36867455Chiauzzi E, Robinson A, Martin K, Petersen C, Wells N, Williams A, Gleason MM. A Relational Agent Intervention for Adolescents Seeking Mental Health Treatment: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Mar 3;12:e44940. doi: 10.2196/44940.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Margaret Gleason, MD principal investigator
Children's Hospital of The King's Daughters
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Woebot for Adolescents (W-GenZD) Mobile Application and CBT-Lite Teletherapy Group in people with Depression and Anxiety, run by Woebot Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usage Rating Profile-Intervention Revised (URP-IR), Feasibility Subscale (time frame: End-of-treatment (4 weeks from baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05372913, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2024.