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TreadWill is a fully automated digital intervention that provides a multi-modal treatment for depressive symptoms. It includes:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full intervention | Experimental | This group receives the full-featured intervention, including CCBT, CBM, Mindfulness, chatbot with many interactive elements. |
|
| Limited CCBT control group | Active Comparator | This group receives feature-limited intervention (text-based computerized CBT) |
|
| Waitlist control group | Other | This group receives waitlist control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interactive and full-featured intervention | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time spent with the program |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Change in Generalized Anxiety Disorder 7 score (Intermediate reports) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nitin Gupta, PhD | Contact | +91-512-679-4384 | guptan@iitk.ac.in |
| Name | Affiliation | Role |
|---|---|---|
| Nitin Gupta, PhD | Indian Institute of Technology Kanpur | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indian Institute of Technology Kanpur | Recruiting | Kanpur | Uttar Pradesh | 208016 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28254959 | Background | 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. | |
| 29422409 |
| Label | URL |
|---|---|
| Link for TreadWill study | View source |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004347 | Drug Interactions |
| ID | Term |
|---|---|
| D000069437 | Pharmacological Phenomena |
| D002620 | Pharmacological and Toxicological Phenomena |
| D010829 | Physiological Phenomena |
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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.
|
| Feature-limited CCBT | 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 | Other | Participants will be put on a waitlist for a period of 6 weeks. |
|
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) |
| 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 |
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) |
| 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 |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Background |
| 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. |