TreadWill, an Automated Intervention for Depressive Symptoms

May 3, 2021 updated by: Nitin Gupta, Indian Institute of Technology Kanpur

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

TreadWill is a fully automated digital intervention that provides a multi-modal treatment for depressive symptoms. It includes:

  1. Slides and interactive text-based conversations based on Cognitive Behavioral Therapy (CBT);
  2. Mindfulness videos;
  3. Game-based Cognitive Bias Modification paradigms;
  4. 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • India
    • Uttar Pradesh
      • Kanpur, Uttar Pradesh, India, 208016
        • Recruiting
        • Indian Institute of Technology Kanpur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Full intervention
This group receives the full-featured intervention, including CCBT, CBM, Mindfulness, chatbot with many interactive elements.
Behavioral: Interactive and full-featured intervention
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.
Active Comparator: Limited CCBT control group
This group receives feature-limited intervention (text-based computerized CBT)
Behavioral: Feature-limited CCBT
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
Other: Waitlist control group
This group receives waitlist control.
Other: Waitlist control
Participants will be put on a waitlist for a period of 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient Health Questionnaire-9 score
Time Frame: change from baseline to program completion or last usage (upto 90 days).
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
Time Frame: baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion
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
Time Frame: from beginning till study completion date (expected within 1 year from the trial start date)
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
Time Frame: 90-120 days after program completion
Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome.
90-120 days after program completion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient Health Questionnaire-9 score (Intermediate reports)
Time Frame: after modules 1 (average 1 week), 2 (average 2 weeks), 3 (average 3 weeks), 4 (average 4 weeks) and 5 (average 5 weeks)
Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome.
after modules 1 (average 1 week), 2 (average 2 weeks), 3 (average 3 weeks), 4 (average 4 weeks) and 5 (average 5 weeks)
Change in Generalized Anxiety Disorder 7 score (Intermediate reports)
Time Frame: after modules 1 (average 1 week), 2 (average 2 weeks), 3 (average 3 weeks), 4 (average 4 weeks) and 5 (average 5 weeks)
Standard questionnaire for generalized anxiety symptoms. Total score is used; lower score indicates better outcome.
after modules 1 (average 1 week), 2 (average 2 weeks), 3 (average 3 weeks), 4 (average 4 weeks) and 5 (average 5 weeks)
User experience survey
Time Frame: after module 3 (average 3 weeks) and module 6 (upto 90 days) of program
Computerized survey to get user feedback on the features of the program.
after module 3 (average 3 weeks) and module 6 (upto 90 days) of program
Time spent in playing games
Time Frame: from beginning till study completion date (expected within 1 year from the trial start date)
Measurement of the total time for which games are played (in seconds).
from beginning till study completion date (expected within 1 year from the trial start date)
Frequency of playing games
Time Frame: from beginning till study completion date (expected within 1 year from the trial start date)
The total number of times for which the games were played
from beginning till study completion date (expected within 1 year from the trial start date)
Feedback on the games
Time Frame: from beginning till study completion date (expected within 1 year from the trial start date)
The number of upvotes and downvotes received on games.
from beginning till study completion date (expected within 1 year from the trial start date)
Change in mood during the program
Time Frame: from beginning till study completion date (expected within 1 year from the trial start date)
Users in the experimental group, using the chatbot, will indicate their mood in one of the three categories: positive, neutral, and negative.
from beginning till study completion date (expected within 1 year from the trial start date)
Change in completion of worksheets
Time Frame: from beginning till study completion date (expected within 1 year from the trial start date)
Automated measure of number of worksheets completed for experimental and active comparator group.
from beginning till study completion date (expected within 1 year from the trial start date)
Use of personalization in the chatbot
Time Frame: from beginning till study completion date (expected within 1 year from the trial start date)
The number of times the users change their preferred frequencies of modules in the chatbot.
from beginning till study completion date (expected within 1 year from the trial start date)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indian Institute of Technology Kanpur

Investigators

  • Principal Investigator: Nitin Gupta, PhD, Indian Institute of Technology Kanpur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2021

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

December 30, 2020

First Submitted That Met QC Criteria

January 8, 2021

First Posted (Actual)

January 11, 2021

Study Record Updates

Last Update Posted (Actual)

May 4, 2021

Last Update Submitted That Met QC Criteria

May 3, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IITK/IEC/2019-20/II/4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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