Anxiety, Depression
Conditions
Keywords
Mental Health, Adolescence, Digital Therapeutic, Cognitive Behavioral Therapy, Chatbot, Mental Health App
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.
Interventions
DEVICEWoebot 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.
BEHAVIORALCBT-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.
Sponsors
Children's Hospital of The King's Daughters
Woebot Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usage Rating Profile-Intervention Revised (URP-IR), Feasibility Subscale | End-of-treatment (4 weeks from baseline) | Measure of feasibility. A 6-item subscale that inquires about factors that impact treatment usage (i.e., intervention quality). Items (e.g., The total time required to do the treatment procedures was manageable) are rated on a 6-point Likert scale (1 = strongly disagree to 6 = strongly agree). Total feasibility scores range from 6-36, with higher scores indicating greater intervention feasibility with the W-GenZD mobile application or the CBT-Lite teletherapy groups. |
| Usage Rating Profile-Intervention Revised (URP-IR), Acceptability Subscale | End-of-treatment (4 weeks from baseline) | Measure of acceptability. A 9-item subscale that inquires about intervention acceptability. For the purposes of this study, an adapted 6-item version of the subscale was utilized. Items (e.g., This treatment is an effective choice for addressing a variety of depression concerns) are rated on a 6-point Likert scale (1 = strongly disagree to 6 = strongly agree). Total acceptability scores range from 6-36, with higher scores indicating greater intervention acceptability with the W-GenZD mobile application or the CBT-Lite teletherapy groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire, 8 Items (PHQ-8) | Baseline; end-of-treatment (4 weeks from baseline); change from baseline to end-of-treatment at 4 weeks | Measure of depression severity. An 8-item abbreviated version of the PHQ-9 used to assess depressive symptomatology over the past 2 weeks. The PHQ-8 excludes an item assessing suicidality. Items (e.g., Over the last 2 weeks, how often have you been bothered by ... feeling down, depressed or hopeless?) are rated on a 4-point Likert scale (0 = not at all to 3 = nearly every day). Total scores range from 0-24, with higher scores indicating increased severity of depressive symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 71 |
| 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.
CBT-Lite Teletherapy: 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. | 70 |
| Total | 141 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Protocol Violation | 2 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | CBT-Lite Teletherapy Group | Total | W-GenZD Mobile Application Group |
|---|---|---|---|
| Age, Customized Age, Categorical 13 years | 14 Participants | 28 Participants | 14 Participants |
| Age, Customized Age, Categorical 14 years | 19 Participants | 44 Participants | 25 Participants |
| Age, Customized Age, Categorical 15 years | 14 Participants | 31 Participants | 17 Participants |
| Age, Customized Age, Categorical 16 years | 19 Participants | 28 Participants | 9 Participants |
| Age, Customized Age, Categorical 17 years | 4 Participants | 10 Participants | 6 Participants |
| Caregiver Employment Status Employed, full time | 44 Participants | 85 Participants | 41 Participants |
| Caregiver Employment Status Employed, part time | 4 Participants | 12 Participants | 8 Participants |
| Caregiver Employment Status Not employed, looking for work | 2 Participants | 6 Participants | 4 Participants |
| Caregiver Employment Status Not employed, not looking for work | 3 Participants | 3 Participants | 0 Participants |
| Caregiver Employment Status On disability, not able to work | 2 Participants | 4 Participants | 2 Participants |
| Caregiver Employment Status Prefer not to answer | 4 Participants | 8 Participants | 4 Participants |
| Caregiver Employment Status Primary care-taker at home, not employed outside of the home | 8 Participants | 19 Participants | 11 Participants |
| Caregiver Employment Status Retired | 3 Participants | 4 Participants | 1 Participants |
| Caregiver Insurance Type Medicaid and similar insurance | 13 Participants | 39 Participants | 26 Participants |
| Caregiver Insurance Type Medicare | 2 Participants | 3 Participants | 1 Participants |
| Caregiver Insurance Type Multiple sources | 3 Participants | 7 Participants | 4 Participants |
| Caregiver Insurance Type No insurance | 0 Participants | 1 Participants | 1 Participants |
| Caregiver Insurance Type Prefer not to answer | 2 Participants | 2 Participants | 0 Participants |
| Caregiver Insurance Type Private insurance | 36 Participants | 66 Participants | 30 Participants |
| Caregiver Insurance Type TRICARE or other military health care | 14 Participants | 20 Participants | 6 Participants |
| Caregiver Insurance Type VA: Past and present | 0 Participants | 3 Participants | 3 Participants |
| Caregiver Marital Status Divorced / Separated | 11 Participants | 29 Participants | 18 Participants |
| Caregiver Marital Status Married / Partnered / Cohabiting | 43 Participants | 79 Participants | 36 Participants |
| Caregiver Marital Status Prefer not to answer | 4 Participants | 4 Participants | 0 Participants |
| Caregiver Marital Status Single | 11 Participants | 25 Participants | 14 Participants |
| Caregiver Marital Status Widowed | 1 Participants | 4 Participants | 3 Participants |
| Caregiver Relationship to Participant Legal guardian | 5 Participants | 8 Participants | 3 Participants |
| Caregiver Relationship to Participant Parent | 65 Participants | 133 Participants | 68 Participants |
| Concomitant Medications Currently Taking Antidepressants | 11 Participants | 21 Participants | 10 Participants |
| Concomitant Medications Currently Taking Antipsychotics | 0 Participants | 0 Participants | 0 Participants |
| Concomitant Medications Currently Taking Stimulants | 8 Participants | 16 Participants | 8 Participants |
| Gender Identity Agender | 2 Participants | 2 Participants | 0 Participants |
| Gender Identity Different identity | 2 Participants | 3 Participants | 1 Participants |
| Gender Identity Genderqueer | 0 Participants | 1 Participants | 1 Participants |
| Gender Identity Man/boy | 17 Participants | 39 Participants | 22 Participants |
| Gender Identity Non-binary | 4 Participants | 5 Participants | 1 Participants |
| Gender Identity Prefer not to answer | 3 Participants | 5 Participants | 2 Participants |
| Gender Identity Woman/girl | 42 Participants | 86 Participants | 44 Participants |
| Highest Education Level Elementary or middle school (grades 1-8) | 24 Participants | 50 Participants | 26 Participants |
| Highest Education Level High school graduate or GED (grade 12) | 3 Participants | 4 Participants | 1 Participants |
| Highest Education Level Some high school (grades 9-11) | 43 Participants | 87 Participants | 44 Participants |
| Primary Presenting Problem at Intake Anxiety | 39 Participants | 76 Participants | 37 Participants |
| Primary Presenting Problem at Intake Depression | 31 Participants | 65 Participants | 34 Participants |
| Race/Ethnicity, Customized African American | 24 Participants | 48 Participants | 24 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants | 11 Participants | 9 Participants |
| Race/Ethnicity, Customized Mixed Race | 2 Participants | 6 Participants | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 40 Participants | 69 Participants | 29 Participants |
| Sex: Female, Male Female | 54 Participants | 110 Participants | 56 Participants |
| Sex: Female, Male Male | 16 Participants | 31 Participants | 15 Participants |
| Sexual Orientation Asexual | 0 Participants | 2 Participants | 2 Participants |
| Sexual Orientation Bisexual | 11 Participants | 20 Participants | 9 Participants |
| Sexual Orientation Don't know | 1 Participants | 6 Participants | 5 Participants |
| Sexual Orientation Lesbian or gay | 5 Participants | 7 Participants | 2 Participants |
| Sexual Orientation Pansexual | 5 Participants | 13 Participants | 8 Participants |
| Sexual Orientation Pansexual; Asexual | 0 Participants | 2 Participants | 2 Participants |
| Sexual Orientation Prefer not to answer | 2 Participants | 4 Participants | 2 Participants |
| Sexual Orientation Queer | 1 Participants | 2 Participants | 1 Participants |
| Sexual Orientation Straight or heterosexual | 45 Participants | 85 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 0 / 70 |
| other Total, other adverse events | 2 / 71 | 2 / 70 |
| serious Total, serious adverse events | 0 / 71 | 0 / 70 |
Outcome results
Primary
Usage Rating Profile-Intervention Revised (URP-IR), Acceptability Subscale
Measure of acceptability. A 9-item subscale that inquires about intervention acceptability. For the purposes of this study, an adapted 6-item version of the subscale was utilized. Items (e.g., This treatment is an effective choice for addressing a variety of depression concerns) are rated on a 6-point Likert scale (1 = strongly disagree to 6 = strongly agree). Total acceptability scores range from 6-36, with higher scores indicating greater intervention acceptability with the W-GenZD mobile application or the CBT-Lite teletherapy groups.
Time frame: End-of-treatment (4 weeks from baseline)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| W-GenZD Mobile Application Group | Usage Rating Profile-Intervention Revised (URP-IR), Acceptability Subscale | 28.00 score on a scale |
| CBT-Lite Teletherapy Group | Usage Rating Profile-Intervention Revised (URP-IR), Acceptability Subscale | 29.10 score on a scale |
Primary
Usage Rating Profile-Intervention Revised (URP-IR), Feasibility Subscale
Measure of feasibility. A 6-item subscale that inquires about factors that impact treatment usage (i.e., intervention quality). Items (e.g., The total time required to do the treatment procedures was manageable) are rated on a 6-point Likert scale (1 = strongly disagree to 6 = strongly agree). Total feasibility scores range from 6-36, with higher scores indicating greater intervention feasibility with the W-GenZD mobile application or the CBT-Lite teletherapy groups.
Time frame: End-of-treatment (4 weeks from baseline)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| W-GenZD Mobile Application Group | Usage Rating Profile-Intervention Revised (URP-IR), Feasibility Subscale | 30.00 score on a scale |
| CBT-Lite Teletherapy Group | Usage Rating Profile-Intervention Revised (URP-IR), Feasibility Subscale | 30.00 score on a scale |
Secondary
Patient Health Questionnaire, 8 Items (PHQ-8)
Measure of depression severity. An 8-item abbreviated version of the PHQ-9 used to assess depressive symptomatology over the past 2 weeks. The PHQ-8 excludes an item assessing suicidality. Items (e.g., Over the last 2 weeks, how often have you been bothered by ... feeling down, depressed or hopeless?) are rated on a 4-point Likert scale (0 = not at all to 3 = nearly every day). Total scores range from 0-24, with higher scores indicating increased severity of depressive symptoms.
Time frame: Baseline; end-of-treatment (4 weeks from baseline); change from baseline to end-of-treatment at 4 weeks
Population: Multiple imputation used for missing scores at end-of-treatment at 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| W-GenZD Mobile Application Group | Patient Health Questionnaire, 8 Items (PHQ-8) | PHQ-8 at Baseline | 10.65 score on a scale | Standard Deviation 6.31 |
| W-GenZD Mobile Application Group | Patient Health Questionnaire, 8 Items (PHQ-8) | PHQ-8 at Week 4 (EOT) | 8.75 score on a scale | Standard Deviation 4.91 |
| W-GenZD Mobile Application Group | Patient Health Questionnaire, 8 Items (PHQ-8) | PHQ-8 Change from Baseline to Week 4 (EOT) | -1.89 score on a scale | Standard Deviation 4.83 |
| CBT-Lite Teletherapy Group | Patient Health Questionnaire, 8 Items (PHQ-8) | PHQ-8 at Baseline | 11.16 score on a scale | Standard Deviation 5.2 |
| CBT-Lite Teletherapy Group | Patient Health Questionnaire, 8 Items (PHQ-8) | PHQ-8 at Week 4 (EOT) | 9.42 score on a scale | Standard Deviation 4.88 |
| CBT-Lite Teletherapy Group | Patient Health Questionnaire, 8 Items (PHQ-8) | PHQ-8 Change from Baseline to Week 4 (EOT) | -1.74 score on a scale | Standard Deviation 4.33 |
95% CI: [-2.3, 0.96]