TreadWill, an Automated Intervention for Depressive Symptoms

Not Applicable

• Conditions: Depressive Symptoms

• Registration Number: NCT04703491
• Lead Sponsor: Indian Institute of Technology Kanpur

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-12-30
• Study First Submitted QC: 2021-01-08
• Study First Posted: 2021-01-11
• Study Start: 2021-04-27
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-04
• Primary Completion: 2022-01
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Patient Health Questionnaire-9 score	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.

Secondary Outcome Measures

Name	Time	Method
Time spent with the program	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
Follow-up Patient Health Questionnaire-9 score	90-120 days after program completion	Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome.
Change in Generalized Anxiety Disorder 7 score	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.

Trial Locations

Locations (1)

Indian Institute of Technology Kanpur; 🇮🇳 Kanpur, Uttar Pradesh, India