TreadWill, an Automated Intervention for Depressive Symptoms

NCT ID: NCT04703491

Last Updated: 2021-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-27

Study Completion Date

2022-04-30

Brief Summary

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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

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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.

Conditions

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Depressive Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The participant is masked to the intervention assigned to them. All outcome measures are self-reported by the participants through a computer program without any involvement of the experimenters.

Study Groups

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Full intervention

This group receives the full-featured intervention, including CCBT, CBM, Mindfulness, chatbot with many interactive elements.

Group Type EXPERIMENTAL

Interactive and full-featured intervention

Intervention Type BEHAVIORAL

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.

Limited CCBT control group

This group receives feature-limited intervention (text-based computerized CBT)

Group Type ACTIVE_COMPARATOR

Feature-limited CCBT

Intervention Type BEHAVIORAL

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

Waitlist control group

This group receives waitlist control.

Group Type OTHER

Waitlist control

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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

Intervention Type BEHAVIORAL

Waitlist control

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indian Institute of Technology Kanpur

OTHER

Sponsor Role lead

Responsible Party

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Nitin Gupta

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nitin Gupta, PhD

Role: PRINCIPAL_INVESTIGATOR

Indian Institute of Technology Kanpur

Locations

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Indian Institute of Technology Kanpur

Kanpur, Uttar Pradesh, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Nitin Gupta, PhD

Role: CONTACT

+91-512-679-4384

References

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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.

Reference Type BACKGROUND
PMID: 28254959 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29422409 (View on PubMed)

Related Links

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https://www.treadwill.org/iitk

Link for TreadWill study

Other Identifiers

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IITK/IEC/2019-20/II/4

Identifier Type: -

Identifier Source: org_study_id

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