Clinical trial NCT04985331: Digital Therapeutic vs Psychoeducation for Management of Mild to Moderate Depression in Adolescents
Official title: Randomized Controlled Trial of a Digital Therapeutic Versus Psychoeducation for the Management of Mild to Moderate Depression in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Teen
Lead sponsor: Woebot Health
Sponsor class: INDUSTRY
First posted: 2021-08-02
Enrollment: 246
Sex: ALL
Minimum age (years): 16
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present randomized controlled study is to investigate if there is a difference in depression symptoms at 4-weeks among adolescents ages 16-17 years assigned to W-GenZD, a digital therapeutic, as compared to a psychoeducational control group.


Eligibility criteria: Inclusion Criteria:

* Adolescents aged 16-17 years old
* Experiencing mild-moderate depression as indicated by a PHQ-8 score between 5-19, inclusive, assessed at screening/baseline
* Has regular access to a smartphone (Android or iOS smartphone with a recent supported operating system) with reliable WiFi access or sufficient data to engage with assigned study arm for the duration of the study
* Available and committed to engage with the program and complete assessments for an 8-week duration
* Able to read and write in English
* U.S. resident
* Regular, stable dose of antidepressant medications for (e.g. escitalopram/Lexapro, fluoxetine/ Prozac) for at least 60 days at screening with no plans to change medication/dose throughout the study
* If currently receiving psychotherapy, then must be in therapy for at least 4 weeks at screening with no changes planned for the duration of the study
* Participants must be able to understand and willing to provide informed assent and to comply with all study procedures and restrictions

Exclusion Criteria:

* Lifetime diagnosis of a psychotic disorder, including schizophrenia and schizoaffective disorder
* Lifetime diagnosis of bipolar disorder
* Lifetime diagnosis of autistic spectrum disorder or pervasive developmental disorder (e.g. autism, Asperger syndrome, Rett's syndrome, or pervasive developmental disorder not otherwise specified)
* Suicidal attempt or ideation with a plan and intent to harm oneself during the last 12 months
* History of (a) drug and/or alcohol abuse within the past 12 months (determined by self-report)
* Current use of benzodiazepines (e.g. lorazepam, clonazepam, alprazolam, diazepam, triazolam) or certain sleep aids (zolpidem, eszopiclone, zaleplon)
* Previous Woebot Application use

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-8)
timeFrame: Change from Baseline to Mid-Treatment at 2 weeks; Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to 1-Month Follow-up at 8 weeks
Secondary outcomes:
measure: Generalized Anxiety Disorder (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 1-Month Follow-up at 8 weeks
measure: Working Alliance Inventory (WAI-SR)
timeFrame: Difference between mid-treatment at 3 days weeks within treatment and post-treatment at 4 weeks
measure: Mental Health Self-Efficacy Scale (MHSE)
timeFrame: Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to 1-Month Follow-up at 8 weeks
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: Post-treatment (8 weeks from baseline)
measure: Usage Rating Profile Intervention (URPI)
timeFrame: Post-treatment (8 weeks from baseline)
measure: Number of active application days
timeFrame: Post-treatment (8 weeks from baseline)
measure: Number of application messages sent per week
timeFrame: Post-treatment (8 weeks from baseline)
measure: Satisfaction ratings of psychoeducational materials
timeFrame: Post-treatment (8 weeks from baseline)
measure: Mood change ratings after CBT skill application
timeFrame: Post-treatment (8 weeks from baseline)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Woebot Health
state: California
Study officials:
References: