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

NCT ID: NCT05372913

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-11
• Study Completion Date: 2023-02-16

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.

Conditions

Depression; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

W-GenZD Mobile Application Group

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.

Group Type: EXPERIMENTAL

Woebot for Adolescents (W-GenZD) Mobile Application

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

CBT-Lite Teletherapy Group

Intervention Type: 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.

Interventions

Woebot for Adolescents (W-GenZD) Mobile Application

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.

Intervention Type: DEVICE

CBT-Lite Teletherapy Group

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of The King's Daughters

OTHER

Sponsor Role: collaborator

Woebot Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary Margaret Gleason, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of The King's Daughters

Locations

Children's Hospital of The King's Daughters

Norfolk, Virginia, United States

Countries

United States

References

Chiauzzi 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.

Reference Type: DERIVED

PMID: 36867455 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

W-GenZD-003

Identifier Type: -

Identifier Source: org_study_id