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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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.

United States1 site
  • Woebot Health

    San Francisco, California, 94105

Other trials in United States

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 groups in NCT05486611
Study groupRoleWhat they receive
W-GenZD Mobile Application GroupExperimentalParticipants 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 GroupSham comparatorParticipants 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  1. First posted3 Aug 2022
  2. Study start9 Aug 2022
  3. Primary completion6 Oct 2022
  4. Study completion2 Nov 2022

Why it stopped: Terminated due to difficulty enrolling patients in the proposed time frame

Resources

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)
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

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.

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