Feasibility and Acceptability of W-GenZD vs CBT-light Teletherapy for Adolescents Seeking Mental Health Services

Depression Clinical Trial

Official title:

A Randomized Controlled Trial of the Feasibility and Acceptability of W-GenZD Versus CBT-light Teletherapy for Adolescents Seeking Mental Health Services

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05372913
• Other study ID #: W-GenZD-003
• Status: Completed
• Phase: N/A
• Start date: May 11, 2022
• Est. completion date: February 16, 2023

Study information

• Verified date: February 2023
• Source: Woebot Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: February 16, 2023
• Est. primary completion date: January 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression

Intervention

Device:
• W-GenZD Mobile Application
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.

Behavioral:
• CBT-Light Teletherapy
The CBT-Light 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.

Locations

Country	Name	City	State
United States	Children's Hospital of The King's Daughters	Norfolk	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Woebot Health	Children's Hospital of The King's Daughters

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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" or "study group therapist" for participants randomized to the W-GenZD treatment arm or the CBT-light teletherapy treatment arm, respectively.	Difference between mid-treatment at 5 days within treatment and post-treatment at 4 weeks
Primary	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.	End of treatment (4 weeks from baseline)
Primary	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.	End of treatment (4 weeks from baseline)
Primary	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 CBT-light teletherapy groups.	End of treatment (4 weeks from baseline)
Primary	Satisfaction Questionnaire	3 open-ended questions asking participants in the W-GenZD-003 treatment arm what they found most helpful about the W-GenZD mobile application, what would make it better, and if there is any other feedback they would like to share.	End of treatment (4 weeks from baseline)
Primary	Number of CBT-light teletherapy group sessions attended	Group engagement in the total number of sessions attended will be collected during the study to provide quantitative data regarding CBT-light group attendance.	Throughout treatment (from baseline to post-treatment at 4 weeks)
Primary	Number of active days in the W-GenZD application	Application engagement in the total number of active days using the application will be collected during the study to provide quantitative data regarding application utilization.	Throughout treatment (from baseline to post-treatment at 4 weeks)
Primary	Number of active minutes in the W-GenZD application	Application engagement in the total number of active minutes using the application will be collected during the study to provide quantitative data regarding application utilization.	Throughout treatment (from baseline to post-treatment at 4 weeks)
Primary	Number of messages sent per week in the W-GenZD application	Application engagement in the number of messages sent each week within the application will be collected during the study to provide quantitative data regarding application utilization.	Throughout treatment (from baseline to post-treatment at 4 weeks)
Primary	Number of modules completed in the W-GenZD application	Application engagement in the number of modules completed within the application will be collected during the study to provide quantitative data regarding application content engagement.	Throughout treatment (from baseline to post-treatment at 4 weeks)
Primary	Content satisfaction ratings in the W-GenZD application	Application content satisfaction ratings will be collected during the study to provide quantitative data regarding application content engagement.	Throughout treatment (from baseline to post-treatment at 4 weeks)
Secondary	Patient Health Questionnaire for Teens (PHQ-8)	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.	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 8 weeks)
Secondary	Generalized 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.	Change from Baseline to Post-Treatment at 4 weeks; Change from Baseline to Follow-Up at 8 weeks)
Secondary	Mood and Feeling Questionnaire (MFQ)	Measure of mood. A child self-report assessment consisting of 13 descriptive phrases related to the participant's recent feelings and behaviors. Respondents reflect on whether the phrases are "true", "sometimes true", or "not true" of the subject's feelings and behaviors during the past 2 weeks.	Change from Baseline to Post-Treatment at 4 weeks; Change from Baseline to Follow-Up at 8 weeks)