TreadWill, an Automated Intervention for Depressive Symptoms

Indian Institute of Technology Kanpur

Status: Unknown

Conditions: Depressive Symptoms

Treatments: Behavioral: Feature-limited CCBT; Behavioral: Interactive and full-featured intervention; Other: Waitlist control

Study type: Interventional

Funder types: Other

Identifiers

NCT04703491

IITK/IEC/2019-20/II/4

Details and patient eligibility

About

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 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 3 patient groups

Full intervention

Experimental group

Description:

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

Treatment:

Behavioral: Interactive and full-featured intervention

Limited CCBT control group

Active Comparator group

Description:

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

Treatment:

Behavioral: Feature-limited CCBT

Waitlist control group

Other group

Description:

This group receives waitlist control.

Treatment:

Other: Waitlist control