TreadWill, an Automated Intervention for Depressive Symptoms

Overview

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.

Full Title of Study: “A Novel and Adaptive Software for Automated Delivery of Cognitive Behavioral Therapy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: January 2022

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.

Interventions

  • 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.
  • 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
    • Participants will be put on a waitlist for a period of 6 weeks.

Arms, Groups and Cohorts

  • Experimental: Full intervention
    • This group receives the full-featured intervention, including CCBT, CBM, Mindfulness, chatbot with many interactive elements.
  • Active Comparator: Limited CCBT control group
    • This group receives feature-limited intervention (text-based computerized CBT)
  • Other: Waitlist control group
    • This group receives waitlist control.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.
  • 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
  • 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.

Participating in This Clinical Trial

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 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Indian Institute of Technology Kanpur
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nitin Gupta, Associate Professor – Indian Institute of Technology Kanpur
  • Overall Official(s)
    • Nitin Gupta, PhD, Principal Investigator, Indian Institute of Technology Kanpur
  • Overall Contact(s)
    • Nitin Gupta, PhD, +91-512-679-4384, guptan@iitk.ac.in

References

Gilbody S, Brabyn S, Lovell K, Kessler D, Devlin T, Smith L, Araya R, Barkham M, Bower P, Cooper C, Knowles S, Littlewood E, Richards DA, Tallon D, White D, Worthy G; REEACT collaborative. Telephone-supported computerised cognitive-behavioural therapy: REEACT-2 large-scale pragmatic randomised controlled trial. Br J Psychiatry. 2017 May;210(5):362-367. doi: 10.1192/bjp.bp.116.192435. Epub 2017 Mar 2.

Andrews G, Basu A, Cuijpers P, Craske MG, McEvoy P, English CL, Newby JM. Computer therapy for the anxiety and depression disorders is effective, acceptable and practical health care: An updated meta-analysis. J Anxiety Disord. 2018 Apr;55:70-78. doi: 10.1016/j.janxdis.2018.01.001. Epub 2018 Feb 1. Review.

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