Clinical trial NCT05486611: Digital Therapeutic vs Educational App for Depression Among Adolescents
Official title: A Randomized Controlled Trial of a Digital Therapeutic (WB002) and Educational App (ED002) for Depression Among Adolescents
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Keywords: Mental Health
Adolescent
Digital Therapeutic
Chatbot
Mental Health App
Lead sponsor: Woebot Health
Sponsor class: INDUSTRY
First posted: 2022-08-03
Enrollment: 6
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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). 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.


Eligibility criteria: Inclusion Criteria:

1. Be 13-17.5 years of age
2. Be a U.S. Resident
3. Able to read and write in English
4. If currently on medication: regular, stable dose of antidepressant medications (e.g., escitalopram/Lexapro, fluoxetine/Prozac) for at least 60 days at screening
5. If currently receiving psychotherapy: must be in therapy for at least 4 weeks at screening
6. 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
7. Available and committed to engage with the program for a 8-week duration and complete assessments
8. Participants must be able to understand and willing to provide informed assent and to comply with all study procedures and restrictions
9. Willingness to provide parent/guardian contact information to provide eConsent and participate in clinical interviews

Exclusion Criteria:

1. PHQ-A score less than 10
2. Lifetime diagnosis of a psychotic disorder (including schizophrenia or schizoaffective disorder)
3. Lifetime diagnosis of bipolar disorder
4. Lifetime diagnosis of autism spectrum disorder or pervasive developmental disorder (e.g., Asperger syndrome, Rett's syndrome, or pervasive developmental disorder not otherwise specified)
5. Current (past year) diagnosis of a substance use disorder
6. Suicide attempt or suicidal ideation with plan and intent within the past 12 months
7. Previous Woebot application use
8. Enrollment of more than one member of the same household

Primary outcomes:
measure: Patient Health Questionnaire for Teens (PHQ-A)
timeFrame: 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:
measure: General Anxiety Disorder Questionnaire (GAD-7)
timeFrame: 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
measure: Children's Depression Rating Scale-Revised (CDRS-R)
timeFrame: Change from Baseline to Post-treatment at 4 weeks
measure: PROMIS Pediatric Global Health (PGH-7)
timeFrame: Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to Follow-up at 8 weeks
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Post-treatment at 4 weeks
measure: Usage Rating Profile - Intervention (URPI)-Feasibility
timeFrame: Post-treatment at 4 weeks
measure: Usage Rating Profile - Intervention (URPI)-Acceptability
timeFrame: Post-treatment at 4 weeks
measure: Working Alliance Inventory - Short Revised (WAI-SR)
timeFrame: Day 4; Change from Day 4 to Post-treatment at 4 weeks
measure: Alexithymia Questionnaire for Children (AQC)
timeFrame: Change from Baseline to Day 4; Change from Baseline to Post-treatment at 4 weeks
measure: Cognitive Flexibility Inventory (CFI)
timeFrame: Change from Baseline to Post-treatment at 4 weeks
measure: CAR, RELAX, ALONE, FORGET, FRIENDS, TROUBLE (CRAFFT)
timeFrame: Baseline
measure: Woebot Reflection Questionnaire (WRQ)
timeFrame: Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to Follow-up at 8 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Woebot Health
state: California
Study officials:
affiliation: Woebot Health
name: Athena Robinson, PhD
role: PRINCIPAL_INVESTIGATOR
References: