A Novel and Adaptive Software for Automated Delivery of Cognitive Behavioral Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depressive Symptoms
- Sponsor
- Indian Institute of Technology Kanpur
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Change in Patient Health Questionnaire-9 score
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Nitin Gupta
Associate Professor
Indian Institute of Technology Kanpur
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Time spent with the program(from beginning till study completion date (expected within 1 year from the trial start date))
- Follow-up Patient Health Questionnaire-9 score(90-120 days after program completion)
- Change in Generalized Anxiety Disorder 7 score(baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion)