Digital Therapeutic vs Psychoeducation for Management of Mild to Moderate Depression in Adolescents

Back to results

Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

W-GenZD

About this trial

This is an interventional treatment trial for Depression, Teen

Eligibility Criteria

16 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Woebot Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

W-GenZD

Psychoeducation Control

Arm Description

W-GenZD is powered by natural language processing and machine learning techniques, the brief, self-guided intervention draws from cognitive behavioral therapy (CBT), interpersonal psychotherapy (IPT-A) and some 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 medical application is designed to be targeted, relevant, tailored, and integrated into the lived experience of adolescents, capable of delivering the appropriate technique for the problem at hand, at the time of need.

The control for this study is the scheduled delivery of digital psychoeducational files (PDFs). The PDFs were selected to provide information on depression, anxiety and stress, as well as outline common coping skills.

Outcomes

Primary Outcome Measures

Patient Health Questionnaire (PHQ-8)

Measure of depression severity. Total score between 0-27, where higher scores indicate greater levels of depression.

Secondary Outcome Measures

Generalized Anxiety Disorder (GAD-7)

Measure of anxiety. Total score between 0-21, where higher scores indicate greater levels of anxiety.

Working Alliance Inventory (WAI-SR)

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.

Mental Health Self-Efficacy Scale (MHSE)

Assesses confidence in managing stress, depression, and anxiety. Range is 10 to 60, with higher scores indicating more self-efficacy.

Client Satisfaction Questionnaire (CSQ)

Range from 8 to 32, with higher values indicating higher satisfaction

Usage Rating Profile Intervention (URPI)

Measurement of feasibility and acceptability. Scores range from 6-36, with higher scores indicating greater feasibility and acceptability.

Number of active application days

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.

Number of application messages sent per week

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.

Satisfaction ratings of psychoeducational materials

Satisfaction metrics in the total number of 'Thumbs up' (likes) or 'Thumbs down' (dislikes) will be collected during the study to provide quantitative data regarding satisfaction with program content.

Mood change ratings after CBT skill application

Satisfaction metrics in the total number of mood change ratings of 'same', 'better', or 'worse, after learning a CBT skill application will be collected during the study to provide quantitative data regarding satisfaction with content.

Full Information

NCT ID

NCT04985331

First Posted

July 8, 2021

Last Updated

January 4, 2022

Sponsor

Woebot Health

1. Study Identification

Unique Protocol Identification Number

NCT04985331

Brief Title

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

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

August 2, 2021 (Actual)

Primary Completion Date

December 16, 2021 (Actual)

Study Completion Date

January 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Woebot Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Teen

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

246 (Actual)

8. Arms, Groups, and Interventions

Arm Title

W-GenZD

Arm Type

Experimental

Arm Description

W-GenZD is powered by natural language processing and machine learning techniques, the brief, self-guided intervention draws from cognitive behavioral therapy (CBT), interpersonal psychotherapy (IPT-A) and some 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 medical application is designed to be targeted, relevant, tailored, and integrated into the lived experience of adolescents, capable of delivering the appropriate technique for the problem at hand, at the time of need.

Arm Title

Psychoeducation Control

Arm Type

No Intervention

Arm Description

The control for this study is the scheduled delivery of digital psychoeducational files (PDFs). The PDFs were selected to provide information on depression, anxiety and stress, as well as outline common coping skills.

Intervention Type

Device

Intervention Name(s)

W-GenZD

Intervention Description

W-GenZD is a 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.

Primary Outcome Measure Information:

Title

Patient Health Questionnaire (PHQ-8)

Description

Measure of depression severity. Total score between 0-27, where higher scores indicate greater levels of depression.

Time Frame

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 Outcome Measure Information:

Title

Generalized Anxiety Disorder (GAD-7)

Description

Measure of anxiety. Total score between 0-21, where higher scores indicate greater levels of anxiety.

Time Frame

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

Title

Working Alliance Inventory (WAI-SR)

Description

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.

Time Frame

Difference between mid-treatment at 3 days weeks within treatment and post-treatment at 4 weeks

Title

Mental Health Self-Efficacy Scale (MHSE)

Description

Assesses confidence in managing stress, depression, and anxiety. Range is 10 to 60, with higher scores indicating more self-efficacy.

Time Frame

Change from Baseline to Post-treatment at 4 weeks; Change from Baseline to 1-Month Follow-up at 8 weeks

Title

Client Satisfaction Questionnaire (CSQ)

Description

Range from 8 to 32, with higher values indicating higher satisfaction

Time Frame