Clinical trial NCT04703491: TreadWill, an Automated Intervention for Depressive Symptoms
Official title: A Novel and Adaptive Software for Automated Delivery of Cognitive Behavioral Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Symptoms
Keywords: depression
anxiety
CCBT
CBM
chatbot
CBT
mindfulness
Lead sponsor: Indian Institute of Technology Kanpur
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

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

Primary outcomes:
measure: Change in Patient Health Questionnaire-9 score
timeFrame: change from baseline to program completion or last usage (upto 90 days).
Secondary outcomes:
measure: Change in Generalized Anxiety Disorder 7 score
timeFrame: baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion
measure: Time spent with the program
timeFrame: from beginning till study completion date (expected within 1 year from the trial start date)
measure: Follow-up Patient Health Questionnaire-9 score
timeFrame: 90-120 days after program completion
Other outcomes:
measure: Change in Patient Health Questionnaire-9 score (Intermediate reports)
timeFrame: after modules 1 (average 1 week), 2 (average 2 weeks), 3 (average 3 weeks), 4 (average 4 weeks) and 5 (average 5 weeks)
measure: Change in Generalized Anxiety Disorder 7 score (Intermediate reports)
timeFrame: after modules 1 (average 1 week), 2 (average 2 weeks), 3 (average 3 weeks), 4 (average 4 weeks) and 5 (average 5 weeks)
measure: User experience survey
timeFrame: after module 3 (average 3 weeks) and module 6 (upto 90 days) of program
measure: Time spent in playing games
timeFrame: from beginning till study completion date (expected within 1 year from the trial start date)
measure: Frequency of playing games
timeFrame: from beginning till study completion date (expected within 1 year from the trial start date)
measure: Feedback on the games
timeFrame: from beginning till study completion date (expected within 1 year from the trial start date)
measure: Change in mood during the program
timeFrame: from beginning till study completion date (expected within 1 year from the trial start date)
measure: Change in completion of worksheets
timeFrame: from beginning till study completion date (expected within 1 year from the trial start date)
measure: Use of personalization in the chatbot
timeFrame: from beginning till study completion date (expected within 1 year from the trial start date)
Locations:
city: Kanpur
country: India
facility: Indian Institute of Technology Kanpur
state: Uttar Pradesh
Study officials:
affiliation: Indian Institute of Technology Kanpur
name: Nitin Gupta, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.