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

Primary Purpose

Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
W-GenZD Mobile Application
CBT-Light Teletherapy
Sponsored by
Woebot Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Mental Health, Adolescence, Digital Therapeutic, Cognitive Behavioral Therapy, Chatbot, Mental Health App

Eligibility Criteria

13 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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 with no plans to change medication/dose throughout the study
  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

Sites / Locations

  • Children's Hospital of The King's Daughters

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

W-GenZD Mobile Application Group

CBT-Light Teletherapy Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Usage Rating Profile Intervention (URPI)-Feasibility
Measure of feasibility. A 6-item subscale that inquires about factors that impact treatment usage (i.e., intervention quality). Responses range from 1 = "slightly disagree" to 6 = "strongly agree". Scores are averages, with greater scores indicating greater intervention feasibility.
Usage Rating Profile Intervention (URPI)-Acceptability
Measure of acceptability. A 6-item subscale that inquires about intervention acceptability. Responses range from 1 = "slightly disagree" to 6 = "strongly agree". Scores are averages, with greater scores indicating greater intervention acceptability.
Client Satisfaction Questionnaire (CSQ-8)
An 8-item measure used to assess client's satisfaction with treatment on a 4-point scale (1 = "very dissatisfied" to 4 = "very satisfied"). Example questions include, "How would you rate the quality of service you received"? and "Did you get the kind of service you wanted?" Total sums range from 8-32, with high scores indicating greater satisfaction with the W-GenZD mobile application or the CBT-light teletherapy groups.
Satisfaction Questionnaire
3 open-ended questions asking participants in the W-GenZD-003 treatment arm what they found most helpful about the W-GenZD mobile application, what would make it better, and if there is any other feedback they would like to share.
Number of CBT-light teletherapy group sessions attended
Group engagement in the total number of sessions attended will be collected during the study to provide quantitative data regarding CBT-light group attendance.
Number of active days in the W-GenZD application
Application engagement in the total number of active days using the application will be collected during the study to provide quantitative data regarding application utilization.
Number of active minutes in the W-GenZD application
Application engagement in the total number of active minutes using the application will be collected during the study to provide quantitative data regarding application utilization.
Number of messages sent per week in the W-GenZD application
Application engagement in the number of messages sent each week within the application will be collected during the study to provide quantitative data regarding application utilization.
Number of modules completed in the W-GenZD application
Application engagement in the number of modules completed within the application will be collected during the study to provide quantitative data regarding application content engagement.
Content satisfaction ratings in the W-GenZD application
Application content satisfaction ratings will be collected during the study to provide quantitative data regarding application content engagement.

Secondary Outcome Measures

Patient Health Questionnaire for Teens (PHQ-8)
Measure of depression severity. An 8-item abbreviated version of the PHQ-9 used to assess mood and anxiety symptoms respectively. The PHQ-8 excludes an item assessing suicidality. Total score between 0-27, where higher scores indicate greater levels of depression.
Generalized Anxiety Disorder Questionnaire (GAD-7)
Measure of anxiety. A 7-item brief self-report measure used to assess the frequency and severity of anxious thoughts and behaviors over the past 2 weeks. Total score between 0-21, where higher scores indicate greater levels of anxiety.
Mood and Feeling Questionnaire (MFQ)
Measure of mood. A child self-report assessment consisting of 13 descriptive phrases related to the participant's recent feelings and behaviors. Respondents reflect on whether the phrases are "true", "sometimes true", or "not true" of the subject's feelings and behaviors during the past 2 weeks.

Full Information

First Posted
April 29, 2022
Last Updated
February 22, 2023
Sponsor
Woebot Health
Collaborators
Children's Hospital of The King's Daughters
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1. Study Identification

Unique Protocol Identification Number
NCT05372913
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 11, 2022 (Actual)
Primary Completion Date
January 19, 2023 (Actual)
Study Completion Date
February 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Woebot Health
Collaborators
Children's Hospital of The King's Daughters

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
Keywords
Mental Health, Adolescence, Digital Therapeutic, Cognitive Behavioral Therapy, Chatbot, Mental Health App

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
W-GenZD Mobile Application Group
Arm Type
Experimental
Arm Description
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.
Arm Title
CBT-Light Teletherapy Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
W-GenZD Mobile Application
Intervention Description
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
Behavioral
Intervention Name(s)
CBT-Light Teletherapy
Intervention Description
The CBT-Light 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 Outcome Measure Information:
Title
Usage Rating Profile Intervention (URPI)-Feasibility
Description
Measure of feasibility. A 6-item subscale that inquires about factors that impact treatment usage (i.e., intervention quality). Responses range from 1 = "slightly disagree" to 6 = "strongly agree". Scores are averages, with greater scores indicating greater intervention feasibility.
Time Frame
End of treatment (4 weeks from baseline)
Title
Usage Rating Profile Intervention (URPI)-Acceptability
Description
Measure of acceptability. A 6-item subscale that inquires about intervention acceptability. Responses range from 1 = "slightly disagree" to 6 = "strongly agree". Scores are averages, with greater scores indicating greater intervention acceptability.
Time Frame
End of treatment (4 weeks from baseline)
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
An 8-item measure used to assess client's satisfaction with treatment on a 4-point scale (1 = "very dissatisfied" to 4 = "very satisfied"). Example questions include, "How would you rate the quality of service you received"? and "Did you get the kind of service you wanted?" Total sums range from 8-32, with high scores indicating greater satisfaction with the W-GenZD mobile application or the CBT-light teletherapy groups.
Time Frame
End of treatment (4 weeks from baseline)
Title
Satisfaction Questionnaire
Description
3 open-ended questions asking participants in the W-GenZD-003 treatment arm what they found most helpful about the W-GenZD mobile application, what would make it better, and if there is any other feedback they would like to share.
Time Frame
End of treatment (4 weeks from baseline)
Title
Number of CBT-light teletherapy group sessions attended
Description
Group engagement in the total number of sessions attended will be collected during the study to provide quantitative data regarding CBT-light group attendance.
Time Frame
Throughout treatment (from baseline to post-treatment at 4 weeks)
Title
Number of active days in the W-GenZD application
Description
Application engagement in the total number of active days using the application will be collected during the study to provide quantitative data regarding application utilization.
Time Frame
Throughout treatment (from baseline to post-treatment at 4 weeks)
Title
Number of active minutes in the W-GenZD application
Description
Application engagement in the total number of active minutes using the application will be collected during the study to provide quantitative data regarding application utilization.
Time Frame
Throughout treatment (from baseline to post-treatment at 4 weeks)
Title
Number of messages sent per week in the W-GenZD application
Description
Application engagement in the number of messages sent each week within the application will be collected during the study to provide quantitative data regarding application utilization.
Time Frame
Throughout treatment (from baseline to post-treatment at 4 weeks)
Title
Number of modules completed in the W-GenZD application
Description
Application engagement in the number of modules completed within the application will be collected during the study to provide quantitative data regarding application content engagement.
Time Frame
Throughout treatment (from baseline to post-treatment at 4 weeks)
Title
Content satisfaction ratings in the W-GenZD application
Description
Application content satisfaction ratings will be collected during the study to provide quantitative data regarding application content engagement.
Time Frame
Throughout treatment (from baseline to post-treatment at 4 weeks)
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire for Teens (PHQ-8)
Description
Measure of depression severity. An 8-item abbreviated version of the PHQ-9 used to assess mood and anxiety symptoms respectively. The PHQ-8 excludes an item assessing suicidality. Total score between 0-27, where higher scores indicate greater levels of depression.
Time Frame
Change from Baseline to Mid-Treatment at 2 weeks; Change from Baseline to Post-Treatment at 4 weeks; Change from Baseline to Follow-Up at 8 weeks)
Title
Generalized Anxiety Disorder Questionnaire (GAD-7)
Description
Measure of anxiety. A 7-item brief self-report measure used to assess the frequency and severity of anxious thoughts and behaviors over the past 2 weeks. Total score between 0-21, where higher scores indicate greater levels of anxiety.
Time Frame
Change from Baseline to Post-Treatment at 4 weeks; Change from Baseline to Follow-Up at 8 weeks)
Title
Mood and Feeling Questionnaire (MFQ)
Description
Measure of mood. A child self-report assessment consisting of 13 descriptive phrases related to the participant's recent feelings and behaviors. Respondents reflect on whether the phrases are "true", "sometimes true", or "not true" of the subject's feelings and behaviors during the past 2 weeks.
Time Frame
Change from Baseline to Post-Treatment at 4 weeks; Change from Baseline to Follow-Up at 8 weeks)
Other Pre-specified Outcome Measures:
Title
Working Alliance Inventory-Short Revised (WAI-SR)
Description
Measure of working alliance. A measure of therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Scores range from 5-20, with higher scores indicating greater alliance. The present study utilized the validated 12-item Short-Revised version (WAI-SR) with minor changes to language, replacing "therapist" with "Woebot" or "study group therapist" for participants randomized to the W-GenZD treatment arm or the CBT-light teletherapy treatment arm, respectively.
Time Frame
Difference between mid-treatment at 5 days within treatment and post-treatment at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Margaret Gleason, MD
Organizational Affiliation
Children's Hospital of The King's Daughters
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of The King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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