Back to resultsDigital Therapeutic vs Educational App for Depression Among Adolescents
Primary Purpose
Depression
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
W-GenZD Mobile Application
Digital Education Application (W-EdZD)
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Mental Health, Adolescent, Digital Therapeutic, Chatbot, Mental Health App
Eligibility Criteria
Inclusion Criteria:
- Be 13-17.5 years of age
- Be a U.S. Resident
- Able to read and write in English
- If currently on medication: regular, stable dose of antidepressant medications (e.g., escitalopram/Lexapro, fluoxetine/Prozac) for at least 60 days at screening
- If currently receiving psychotherapy: must be in therapy for at least 4 weeks at screening
- Own or have regular access to a smartphone (operating systems: Android 6 or later and iOS 13 or later) that can receive SMS messages, and has reliable Wi-Fi access or sufficient data to engage with study app
- Available and committed to engage with the program for a 8-week duration and complete assessments
- Participants must be able to understand and willing to provide informed assent and to comply with all study procedures and restrictions
- Willingness to provide parent/guardian contact information to provide eConsent and participate in clinical interviews
Exclusion Criteria:
- PHQ-A score less than 10
- 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., Asperger syndrome, Rett's syndrome, or pervasive developmental disorder not otherwise specified)
- Current (past year) diagnosis of a substance use disorder
- Suicide attempt or suicidal ideation with plan and intent within the past 12 months
- Previous Woebot application use
- Enrollment of more than one member of the same household
Sites / Locations
- Woebot Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
W-GenZD Mobile Application Group
Digital Education Application 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 Digital Education mobile app group will be given instructions on how to download and access the application that will provide general health information. A new article will be provided to the participant at a rate of once per week across the 4 weeks (4 articles total) and they will receive a weekly notification when a new article is available. Each article will be available for one week from release date. We expect a target dosage of roughly 30 minutes per week (120 min), which would make it comparable to Woebot (about 5 min per day X 28 days = 140 min).
Outcomes
Primary Outcome Measures
Patient Health Questionnaire for Teens (PHQ-A)
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.
Secondary Outcome Measures
General 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.
Children's Depression Rating Scale-Revised (CDRS-R)
Measure of depression. The CDRS-R is a brief rating scale based on a semi-structured interview with the child. Designed for 6- to 12-year-olds, it has been successfully used with adolescents. Seventeen symptom areas are assessed during the interview with a 5- to 7-point rating scale: Impaired Schoolwork, Difficulty Having Fun, Social Withdrawal, Appetite Disturbance, Sleep Disturbance, Excessive Fatigue, Physical Complaints, Irritability, Excessive Guilt, Low Self-Esteem, Depressed Feelings, Morbid Ideation, Suicidal Ideation, Excessive Weeping, Depressed Facial Affect, Listless Speech, and Hypoactivity. Total scores range from 17- 113. A score of ≥40 is indicative of depression, whereas a score ≤28 is often used to define remission (minimal or no symptoms).
PROMIS Pediatric Global Health (PGH-7)
Measure of global health. A 7-item self-report measure of a child's global health developed for children and adolescents in the 8-17 age range. Items assess general, physical, mental, and social health, with response options on a 5-point likert scale. Total score ranges from 1-35, where higher scores indicate better health.
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 W-EdZD mobile application.
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.
Working Alliance Inventory - Short Revised (WAI-SR)
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" for participants randomized to the W-GenZD treatment arm.
Alexithymia Questionnaire for Children (AQC)
Measure of the alexithymia construct. A self-report questionnaire based on the original Toronto Alexithymia Scale (TAS-20), revised with language oriented toward children and adolescents. A total of 20 items comprises the AQC, with responses on a 3-point Likert-scale (ranging from 0 = not true to 2 = often true). The AQC measures 3 core factors including difficulty identifying feelings (7 items), difficulty describing feelings (5 items), and externally-oriented thinking (8 items). Higher total scores correspond to an elevated presence of the factor. Emotional awareness can be measured using the 12 items that make up the difficulty identifying feelings and difficulty describing feelings factors, so we will be administering these subscales.
Cognitive Flexibility Inventory (CFI)
Measure of cognitive flexibility. A 20-item assessment designed to measure three aspects of cognitive flexibility: the tendency to perceive difficult situations as controllable; the ability to perceive multiple alternative explanations for life occurrences and human behavior; and the ability to generate multiple alternative solutions to difficult situations. Total scores range from 7-140, with Alternatives scale ranging from 7-91 and Control scale from 7-49. There are currently no established cutoff scores for high, moderate, and low flexibility across the scales, though higher scores indicate greater flexibility.
CAR, RELAX, ALONE, FORGET, FRIENDS, TROUBLE (CRAFFT)
Measure of substance use. A validated 9-item screening tool designed to identify substance use past 12 months, substance-related risk, and substance use disorder in adolescents aged 12-21. Total CRAFFT scores range from 0-6, where a score of 0 indicates low risk level, a score <2 is medium risk, and a score >= 2 is deemed high risk.
Woebot Reflection Questionnaire (WRQ)
Measure of user perceptions on three domains: symptoms, abilities, and quality of life. The 17-item measure assesses user perceptions on symptoms, abilities, and quality of life over the past 2 weeks. The Symptoms domain consists of 4-items asking the user to rate the severity of symptoms related to their mood, such as sadness, stress, irritability, and negative thoughts. The 7-item Abilities domain assesses how well users were able to copy, complete, or navigate responsibilities, activities, or emotions. The Quality of Life domain is 6-items and assesses the frequency of users experienced physical and social wellbeing. All responses are presented with Likert responses. This measure has not undergone psychometric testing and will be used in this study to evaluate its preliminary validity and sensitivity to change against more validated measures.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05486611
Brief Title
Digital Therapeutic vs Educational App for Depression Among Adolescents
Official Title
A Randomized Controlled Trial of a Digital Therapeutic (WB002) and Educational App (ED002) for Depression Among Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to difficulty enrolling patients in the proposed time frame
Study Start Date
August 9, 2022 (Actual)
Primary Completion Date
October 6, 2022 (Actual)
Study Completion Date
November 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Woebot Health
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 investigate the difference in depression symptoms at 4-weeks across two types of programs for addressing depressive symptoms, including Woebot (WB002) and Digital Education (ED002). The secondary aim of this study is to investigate the difference in anxiety symptoms at 4-weeks across the two programs. The tertiary aim of this study is to evaluate the feasibility, acceptability, and satisfaction of each program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Mental Health, Adolescent, Digital Therapeutic, Chatbot, Mental Health App
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
6 (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
Digital Education Application Group
Arm Type
Sham Comparator
Arm Description
Participants assigned to the Digital Education mobile app group will be given instructions on how to download and access the application that will provide general health information. A new article will be provided to the participant at a rate of once per week across the 4 weeks (4 articles total) and they will receive a weekly notification when a new article is available. Each article will be available for one week from release date. We expect a target dosage of roughly 30 minutes per week (120 min), which would make it comparable to Woebot (about 5 min per day X 28 days = 140 min).
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
Device
Intervention Name(s)
Digital Education Application (W-EdZD)
Intervention Description
Digital Education will be available to the participant via the 'Quest GenZ' smartphone application but will be devoid of active elements included in WB002. We will source this material from kidshealth.org, which is supported by Nemours Children's Health. We have received permission to use their content.
The materials are written at an 8th grade reading level and will include general health (e.g., food plate guide, caffeine, online safety, study skills) articles. A new article will be provided to the participant at a rate of once per week across the 4 weeks (4 articles total) and they will receive a weekly notification when a new article is available. Each article will be available for one week from release date.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire for Teens (PHQ-A)
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 Screening to Mid-treatment at 2 weeks; Change from Screening to Post-treatment at 4 weeks; Change from Screening to Follow-up at 6 and 8 weeks
Secondary Outcome Measure Information:
Title
General 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 Mid-treatment at 2 weeks; Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to Follow-up at 6 and 8 weeks
Title
Children's Depression Rating Scale-Revised (CDRS-R)
Description
Measure of depression. The CDRS-R is a brief rating scale based on a semi-structured interview with the child. Designed for 6- to 12-year-olds, it has been successfully used with adolescents. Seventeen symptom areas are assessed during the interview with a 5- to 7-point rating scale: Impaired Schoolwork, Difficulty Having Fun, Social Withdrawal, Appetite Disturbance, Sleep Disturbance, Excessive Fatigue, Physical Complaints, Irritability, Excessive Guilt, Low Self-Esteem, Depressed Feelings, Morbid Ideation, Suicidal Ideation, Excessive Weeping, Depressed Facial Affect, Listless Speech, and Hypoactivity. Total scores range from 17- 113. A score of ≥40 is indicative of depression, whereas a score ≤28 is often used to define remission (minimal or no symptoms).
Time Frame
Change from Baseline to Post-treatment at 4 weeks
Title
PROMIS Pediatric Global Health (PGH-7)
Description
Measure of global health. A 7-item self-report measure of a child's global health developed for children and adolescents in the 8-17 age range. Items assess general, physical, mental, and social health, with response options on a 5-point likert scale. Total score ranges from 1-35, where higher scores indicate better health.
Time Frame
Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to Follow-up at 8 weeks
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 W-EdZD mobile application.
Time Frame
Post-treatment at 4 weeks
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
Post-treatment at 4 weeks
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
Post-treatment at 4 weeks
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" for participants randomized to the W-GenZD treatment arm.
Time Frame
Day 4; Change from Day 4 to Post-treatment at 4 weeks
Title
Alexithymia Questionnaire for Children (AQC)
Description
Measure of the alexithymia construct. A self-report questionnaire based on the original Toronto Alexithymia Scale (TAS-20), revised with language oriented toward children and adolescents. A total of 20 items comprises the AQC, with responses on a 3-point Likert-scale (ranging from 0 = not true to 2 = often true). The AQC measures 3 core factors including difficulty identifying feelings (7 items), difficulty describing feelings (5 items), and externally-oriented thinking (8 items). Higher total scores correspond to an elevated presence of the factor. Emotional awareness can be measured using the 12 items that make up the difficulty identifying feelings and difficulty describing feelings factors, so we will be administering these subscales.
Time Frame
Change from Baseline to Day 4; Change from Baseline to Post-treatment at 4 weeks
Title
Cognitive Flexibility Inventory (CFI)
Description
Measure of cognitive flexibility. A 20-item assessment designed to measure three aspects of cognitive flexibility: the tendency to perceive difficult situations as controllable; the ability to perceive multiple alternative explanations for life occurrences and human behavior; and the ability to generate multiple alternative solutions to difficult situations. Total scores range from 7-140, with Alternatives scale ranging from 7-91 and Control scale from 7-49. There are currently no established cutoff scores for high, moderate, and low flexibility across the scales, though higher scores indicate greater flexibility.
Time Frame
Change from Baseline to Post-treatment at 4 weeks
Title
CAR, RELAX, ALONE, FORGET, FRIENDS, TROUBLE (CRAFFT)
Description
Measure of substance use. A validated 9-item screening tool designed to identify substance use past 12 months, substance-related risk, and substance use disorder in adolescents aged 12-21. Total CRAFFT scores range from 0-6, where a score of 0 indicates low risk level, a score <2 is medium risk, and a score >= 2 is deemed high risk.
Time Frame
Baseline
Title
Woebot Reflection Questionnaire (WRQ)
Description
Measure of user perceptions on three domains: symptoms, abilities, and quality of life. The 17-item measure assesses user perceptions on symptoms, abilities, and quality of life over the past 2 weeks. The Symptoms domain consists of 4-items asking the user to rate the severity of symptoms related to their mood, such as sadness, stress, irritability, and negative thoughts. The 7-item Abilities domain assesses how well users were able to copy, complete, or navigate responsibilities, activities, or emotions. The Quality of Life domain is 6-items and assesses the frequency of users experienced physical and social wellbeing. All responses are presented with Likert responses. This measure has not undergone psychometric testing and will be used in this study to evaluate its preliminary validity and sensitivity to change against more validated measures.
Time Frame
Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to Follow-up at 8 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:
Be 13-17.5 years of age
Be a U.S. Resident
Able to read and write in English
If currently on medication: regular, stable dose of antidepressant medications (e.g., escitalopram/Lexapro, fluoxetine/Prozac) for at least 60 days at screening
If currently receiving psychotherapy: must be in therapy for at least 4 weeks at screening
Own or have regular access to a smartphone (operating systems: Android 6 or later and iOS 13 or later) that can receive SMS messages, and has reliable Wi-Fi access or sufficient data to engage with study app
Available and committed to engage with the program for a 8-week duration and complete assessments
Participants must be able to understand and willing to provide informed assent and to comply with all study procedures and restrictions
Willingness to provide parent/guardian contact information to provide eConsent and participate in clinical interviews
Exclusion Criteria:
PHQ-A score less than 10
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., Asperger syndrome, Rett's syndrome, or pervasive developmental disorder not otherwise specified)
Current (past year) diagnosis of a substance use disorder
Suicide attempt or suicidal ideation with plan and intent within the past 12 months
Previous Woebot application use
Enrollment of more than one member of the same household
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athena Robinson, PhD
Organizational Affiliation
Woebot Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Woebot Health
City
San Francisco
State/Province
California
ZIP/Postal Code
94105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Digital Therapeutic vs Educational App for Depression Among Adolescents
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