DepressionNCT05486611
Digital Therapeutic vs Educational App for Depression Among Adolescents
A study testing W-GenZD Mobile Application and Digital Education Application (W-EdZD) in people with Depression, run by Woebot Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Depression
- What is being tested?
- W-GenZD Mobile Application and Digital Education Application (W-EdZD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2022to 2 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of a Digital Therapeutic (WB002) and Educational App (ED002) for Depression Among Adolescents
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.
- Conditions
- Depression
- Being tested
- W-GenZD Mobile Application, Digital Education Application (W-EdZD)
- Keywords
- Mental Health, Adolescent, Digital Therapeutic, Chatbot, Mental Health App
- Medical subject headings
- Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
W-GenZD Mobile ApplicationDevice
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.
Digital Education Application (W-EdZD)Device
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.
| 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: W-GenZD Mobile Application |
| Digital Education Application Group | Sham comparator | 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). Receives: Device: Digital Education Application (W-EdZD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (11)
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.
Measured: 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
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).
Measured: Change from Baseline to Post-treatment at 4 weeks
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.
Measured: Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to Follow-up at 8 weeks
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.
Measured: Post-treatment at 4 weeks
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.
Measured: Post-treatment at 4 weeks
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.
Measured: Post-treatment at 4 weeks
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.
Measured: Day 4; Change from Day 4 to Post-treatment at 4 weeks
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.
Measured: Change from Baseline to Day 4; Change from Baseline to Post-treatment at 4 weeks
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.
Measured: Change from Baseline to Post-treatment at 4 weeks
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.
Measured: Baseline
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.
Measured: Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to Follow-up at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start9 Aug 2022
- Primary completion6 Oct 2022
- Study completion2 Nov 2022
Why it stopped: Terminated due to difficulty enrolling patients in the proposed time frame
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woebot Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Athena Robinson, PhD, Principal investigator, Woebot Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486611
- Sponsor's protocol ID
- W-GenZD-004
- Status last verified
- Dec 2022
- First submitted
- 1 Aug 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Digital Therapeutic (WB002) and Educational App (ED002) for Depression Among Adolescents
- ClinicalTrials.gov ID
- NCT05486611
- Acronym / sponsor ID
- W-GenZD-004
- Conditions
- Depression
- Keywords
- Mental Health, Adolescent, Digital Therapeutic, Chatbot, Mental Health App
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to difficulty enrolling patients in the proposed time frame
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Woebot HealthIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 6 Oct 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| W-GenZD Mobile Application Group | Experimental | Device: 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. |
| Digital Education Application Group | Sham comparator | Device: Digital Education Application (W-EdZD)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). |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| W-GenZD Mobile ApplicationW-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 |
| Digital Education Application (W-EdZD)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. | Device | Digital Education Application Group |
Primary outcome
Patient Health Questionnaire for Teens (PHQ-A)
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
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.
11 secondary outcomes
General Anxiety Disorder Questionnaire (GAD-7)
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
Children's Depression Rating Scale-Revised (CDRS-R)
Time frame: Change from Baseline to Post-treatment at 4 weeks
PROMIS Pediatric Global Health (PGH-7)
Time frame: Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to Follow-up at 8 weeks
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Post-treatment at 4 weeks
Usage Rating Profile - Intervention (URPI)-Feasibility
Time frame: Post-treatment at 4 weeks
Usage Rating Profile - Intervention (URPI)-Acceptability
Time frame: Post-treatment at 4 weeks
Working Alliance Inventory - Short Revised (WAI-SR)
Time frame: Day 4; Change from Day 4 to Post-treatment at 4 weeks
Alexithymia Questionnaire for Children (AQC)
Time frame: Change from Baseline to Day 4; Change from Baseline to Post-treatment at 4 weeks
Cognitive Flexibility Inventory (CFI)
Time frame: Change from Baseline to Post-treatment at 4 weeks
CAR, RELAX, ALONE, FORGET, FRIENDS, TROUBLE (CRAFFT)
Time frame: Baseline
Woebot Reflection Questionnaire (WRQ)
Time frame: Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to Follow-up at 8 weeks
Results and safety
The study was stopped early (reason given: Terminated due to difficulty enrolling patients in the proposed time frame). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
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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.
Athena Robinson, PhD principal investigator
Woebot Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing W-GenZD Mobile Application and Digital Education Application (W-EdZD) in people with Depression, 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 8 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: stopped early, as of the sponsor's last update on 5 Dec 2022. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: Terminated due to difficulty enrolling patients in the proposed time frame). Results are not available in the source record.
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?
Patient Health Questionnaire for Teens (PHQ-A) (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2022.