TreadWill, an Automated Intervention for Depressive Symptoms

Depressive Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04703491
• Other study ID #: IITK/IEC/2019-20/II/4
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2021
• Est. completion date: April 2022

Study information

• Verified date: May 2021
• Source: Indian Institute of Technology Kanpur
• Contact: Nitin Gupta, PhD
• Phone: +91-512-679-4384
• Email: guptan[@]iitk.ac.in
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

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.
• 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.

Locations

Country	Name	City	State
India	Indian Institute of Technology Kanpur	Kanpur	Uttar Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Indian Institute of Technology Kanpur

Country where clinical trial is conducted

India, 

References & Publications (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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Patient Health Questionnaire-9 score (Intermediate reports)	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)
Other	Change in Generalized Anxiety Disorder 7 score (Intermediate reports)	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)
Other	User experience survey	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
Other	Time spent in playing games	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)
Other	Frequency of playing games	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)
Other	Feedback on the games	The number of upvotes and downvotes received on games.	from beginning till study completion date (expected within 1 year from the trial start date)
Other	Change in mood during the program	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)
Other	Change in completion of worksheets	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)
Other	Use of personalization in the chatbot	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)
Primary	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	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
Secondary	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)
Secondary	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

External Links

•   Link for TreadWill study