Trial Outcomes & Findings for Feasibility and Acceptability of W-GenZD vs CBT-light Teletherapy for Adolescents Seeking Mental Health Services (NCT NCT05372913)
NCT ID: NCT05372913
Last Updated: 2024-10-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
141 participants
Primary outcome timeframe
End-of-treatment (4 weeks from baseline)
Results posted on
2024-10-17
Participant Flow
Participant milestones
| Measure |
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.
|
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 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.
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
70
|
|
Overall Study
COMPLETED
|
69
|
65
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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 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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Feasibility and Acceptability of W-GenZD vs CBT-light Teletherapy for Adolescents Seeking Mental Health Services
Baseline characteristics by cohort
| Measure |
W-GenZD Mobile Application Group
n=71 Participants
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.
|
CBT-Lite Teletherapy Group
n=70 Participants
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.
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age, Categorical · 13 years
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Customized
Age, Categorical · 14 years
|
25 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Customized
Age, Categorical · 15 years
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Customized
Age, Categorical · 16 years
|
9 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Customized
Age, Categorical · 17 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
29 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Gender Identity
Agender
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Gender Identity
Different identity
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Gender Identity
Genderqueer
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Gender Identity
Man/boy
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Gender Identity
Non-binary
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Gender Identity
Prefer not to answer
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Gender Identity
Woman/girl
|
44 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Sexual Orientation
Asexual
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sexual Orientation
Bisexual
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sexual Orientation
Don't know
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sexual Orientation
Lesbian or gay
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sexual Orientation
Pansexual
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sexual Orientation
Pansexual; Asexual
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sexual Orientation
Prefer not to answer
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sexual Orientation
Queer
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sexual Orientation
Straight or heterosexual
|
40 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Highest Education Level
Elementary or middle school (grades 1-8)
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Highest Education Level
High school graduate or GED (grade 12)
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Highest Education Level
Some high school (grades 9-11)
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Primary Presenting Problem at Intake
Anxiety
|
37 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Primary Presenting Problem at Intake
Depression
|
34 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Concomitant Medications
Currently Taking Antidepressants
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Concomitant Medications
Currently Taking Antipsychotics
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Concomitant Medications
Currently Taking Stimulants
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Caregiver Relationship to Participant
Legal guardian
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Caregiver Relationship to Participant
Parent
|
68 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Caregiver Employment Status
Employed, full time
|
41 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Caregiver Employment Status
Employed, part time
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Caregiver Employment Status
Not employed, looking for work
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Caregiver Employment Status
Not employed, not looking for work
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Caregiver Employment Status
On disability, not able to work
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Caregiver Employment Status
Prefer not to answer
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Caregiver Employment Status
Primary care-taker at home, not employed outside of the home
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Caregiver Employment Status
Retired
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Caregiver Marital Status
Divorced / Separated
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Caregiver Marital Status
Married / Partnered / Cohabiting
|
36 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Caregiver Marital Status
Prefer not to answer
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Caregiver Marital Status
Single
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Caregiver Marital Status
Widowed
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Caregiver Insurance Type
Medicaid and similar insurance
|
26 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Caregiver Insurance Type
Medicare
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Caregiver Insurance Type
Multiple sources
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Caregiver Insurance Type
No insurance
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Caregiver Insurance Type
Prefer not to answer
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Caregiver Insurance Type
Private insurance
|
30 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Caregiver Insurance Type
TRICARE or other military health care
|
6 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Caregiver Insurance Type
VA: Past and present
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
W-GenZD Mobile Application Group
n=71 Participants
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.
|
CBT-Lite Teletherapy Group
n=70 Participants
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.
|
|---|---|---|
|
Usage Rating Profile-Intervention Revised (URP-IR), Feasibility Subscale
|
30.00 score on a scale
Interval 28.5 to 31.5
|
30.00 score on a scale
Interval 28.2 to 31.8
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
W-GenZD Mobile Application Group
n=71 Participants
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.
|
CBT-Lite Teletherapy Group
n=70 Participants
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.
|
|---|---|---|
|
Usage Rating Profile-Intervention Revised (URP-IR), Acceptability Subscale
|
28.00 score on a scale
Interval 26.05 to 29.95
|
29.10 score on a scale
Interval 26.7 to 31.51
|
SECONDARY outcome
Timeframe: Baseline; end-of-treatment (4 weeks from baseline); change from baseline to end-of-treatment at 4 weeksPopulation: Multiple imputation used for missing scores at 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.
Outcome measures
| Measure |
W-GenZD Mobile Application Group
n=71 Participants
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.
|
CBT-Lite Teletherapy Group
n=70 Participants
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.
|
|---|---|---|
|
Patient Health Questionnaire, 8 Items (PHQ-8)
PHQ-8 at Baseline
|
10.65 score on a scale
Standard Deviation 6.31
|
11.16 score on a scale
Standard Deviation 5.20
|
|
Patient Health Questionnaire, 8 Items (PHQ-8)
PHQ-8 at Week 4 (EOT)
|
8.75 score on a scale
Standard Deviation 4.91
|
9.42 score on a scale
Standard Deviation 4.88
|
|
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
|
-1.74 score on a scale
Standard Deviation 4.33
|
Adverse Events
W-GenZD Mobile Application Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
CBT-Lite Teletherapy Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
W-GenZD Mobile Application Group
n=71 participants at risk
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.
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CBT-Lite Teletherapy Group
n=70 participants at risk
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.
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Psychiatric disorders
Adverse Event, Mild Severity
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1.4%
1/71 • Number of events 1 • Throughout study (from baseline through 8 weeks)
Safety was monitored via: 1) concerning language detection within each intervention; 2) biweekly phone check-ins by the research coordinator with the caregiver; 3) spontaneous report to study personnel. Upon learning of a potential safety concern, on-call licensed study personnel contacted the caregiver to assess the adolescent's safety, identify the level of intervention needed, and provide resources as needed. Participants were withdrawn if they were deemed to require a higher level of care.
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1.4%
1/70 • Number of events 1 • Throughout study (from baseline through 8 weeks)
Safety was monitored via: 1) concerning language detection within each intervention; 2) biweekly phone check-ins by the research coordinator with the caregiver; 3) spontaneous report to study personnel. Upon learning of a potential safety concern, on-call licensed study personnel contacted the caregiver to assess the adolescent's safety, identify the level of intervention needed, and provide resources as needed. Participants were withdrawn if they were deemed to require a higher level of care.
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Psychiatric disorders
Adverse Event, Moderate Severity
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1.4%
1/71 • Number of events 1 • Throughout study (from baseline through 8 weeks)
Safety was monitored via: 1) concerning language detection within each intervention; 2) biweekly phone check-ins by the research coordinator with the caregiver; 3) spontaneous report to study personnel. Upon learning of a potential safety concern, on-call licensed study personnel contacted the caregiver to assess the adolescent's safety, identify the level of intervention needed, and provide resources as needed. Participants were withdrawn if they were deemed to require a higher level of care.
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1.4%
1/70 • Number of events 1 • Throughout study (from baseline through 8 weeks)
Safety was monitored via: 1) concerning language detection within each intervention; 2) biweekly phone check-ins by the research coordinator with the caregiver; 3) spontaneous report to study personnel. Upon learning of a potential safety concern, on-call licensed study personnel contacted the caregiver to assess the adolescent's safety, identify the level of intervention needed, and provide resources as needed. Participants were withdrawn if they were deemed to require a higher level of care.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place