TreadWill, an Automated Intervention for Depressive Symptoms

Study Overview
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Brief Summary
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TreadWill is a fully automated digital intervention that provides a multi-modal treatment for depressive symptoms. It includes: Slides and interactive text-based conversations based on Cognitive Behavioral Therapy (CBT); Mindfulness videos; Game-based Cognitive Bias Modification paradigms; An empathetic chatbot. This study's primary aim is to test the differential effectiveness of this full-featured version of TreadWill compared to a text-based CBT program.

Detailed Description
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TreadWill is an online tool to deliver automated intervention for depressive symptoms. TreadWill helps the participants learn the concepts of Cognitive Behavioral Therapy (CBT), and practice mindfulness in an interactive manner. It also has games based on Cognitive Bias Modification (CBM) and an empathetic chatbot. We hypothesize that participants using TreadWill will show a significant reduction in depressive symptoms and will show engagement with the program. To test this hypothesis, we are conducting a randomized controlled trial. We will randomize participants into three groups: experimental, active control, and waitlist. Participants randomized to the experimental group will get access to the full-featured version of TreadWill as described above. Participants randomized to the active control group will have access to a limited version of TreadWill designed to deliver basic CBT in plain text format. The waitlisted participants will be put on a waitlist for 6 weeks.

Official Title
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A Novel and Adaptive Software for Automated Delivery of Cognitive Behavioral Therapy

Conditions
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Depressive Symptoms

Intervention / Treatment
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* Behavioral: Interactive and full-featured intervention
* Behavioral: Feature-limited CCBT
* Other: Waitlist control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fluent in English PHQ-9 Score from 5 to 19 Access to an internet-enabled Android smartphone Plan to use TreadWill in Google Chrome browser Agree to allow notifications from TreadWill Agree to add TreadWill to Home screen Have email on one of the HTML-enabled platforms including Gmail, Outlook, Yahoo, Rediffmail, AOL, Hotmail. Exclusion Criteria: Suicide ideation (score greater than 0 on the 9th question of PHQ-9 and score greater than 4 on SIQ) Unemployed Current or previous diagnosis of bipolar disorder/manic-depressive disorder or psychosis Prospective participants who say they only want to check out the program and do not plan to complete it are excluded. Used an earlier version of TreadWill

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full intervention<br>This group receives the full-featured intervention, including CCBT, CBM, Mindfulness, chatbot with many interactive elements. | Behavioral: Interactive and full-featured intervention<br>* Participants will go through an automated program. Participants will learn and practice the techniques of CBT through multimedia elements. They will play games based on Cognitive Bias Modification (CBM) paradigms, practice mindfulness, and chat with an automated empathic chatbot.<br>|
| Active Comparator: Limited CCBT control group<br>This group receives feature-limited intervention (text-based computerized CBT) | Behavioral: Feature-limited CCBT<br>* Participants will be going through an automated program. Participants will learn and practice the techniques of CBT in a plain-text format with reduced features<br>|
| Other: Waitlist control group<br>This group receives waitlist control. | Other: Waitlist control<br>* Participants will be put on a waitlist for a period of 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Health Questionnaire-9 score | Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome. | change from baseline to program completion or last usage (upto 90 days). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Generalized Anxiety Disorder 7 score | Standard questionnaire for generalized anxiety symptoms. Total score is used; lower score indicates better outcome. | baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion | 
| Time spent with the program | Automated measure of time spent on the program for experimental and active comparator group | from beginning till study completion date (expected within 1 year from the trial start date) | 
| Follow-up Patient Health Questionnaire-9 score | Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome. | 90-120 days after program completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, anxiety, CCBT, CBM, chatbot, CBT, mindfulness