TreadWill, an Automated Intervention for Depressive Symptoms
Primary Purpose
Depressive Symptoms
Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Interactive and full-featured intervention
Feature-limited CCBT
Waitlist control
Sponsored by
About this trial
This is an interventional supportive care trial for Depressive Symptoms focused on measuring depression, anxiety, CCBT, CBM, chatbot, CBT, mindfulness
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
Sites / Locations
- Indian Institute of Technology KanpurRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
Full intervention
Limited CCBT control group
Waitlist control group
Arm Description
This group receives the full-featured intervention, including CCBT, CBM, Mindfulness, chatbot with many interactive elements.
This group receives feature-limited intervention (text-based computerized CBT)
This group receives waitlist control.
Outcomes
Primary Outcome Measures
Change in Patient Health Questionnaire-9 score
Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome.
Secondary Outcome Measures
Change in Generalized Anxiety Disorder 7 score
Standard questionnaire for generalized anxiety symptoms. Total score is used; lower score indicates better outcome.
Time spent with the program
Automated measure of time spent on the program for experimental and active comparator group
Follow-up Patient Health Questionnaire-9 score
Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome.
Full Information
NCT ID
NCT04703491
First Posted
December 30, 2020
Last Updated
May 3, 2021
Sponsor
Indian Institute of Technology Kanpur
1. Study Identification
Unique Protocol Identification Number
NCT04703491
Brief Title
TreadWill, an Automated Intervention for Depressive Symptoms
Official Title
A Novel and Adaptive Software for Automated Delivery of Cognitive Behavioral Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 27, 2021 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indian Institute of Technology Kanpur
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
TreadWill is a fully automated digital intervention that provides a multi-modal treatment for depressive symptoms. It includes:
Slides and interactive text-based conversations based on Cognitive Behavioral Therapy (CBT);
Mindfulness videos;
Game-based Cognitive Bias Modification paradigms;
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms
Keywords
depression, anxiety, CCBT, CBM, chatbot, CBT, mindfulness
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Full intervention
Arm Type
Experimental
Arm Description
This group receives the full-featured intervention, including CCBT, CBM, Mindfulness, chatbot with many interactive elements.
Arm Title
Limited CCBT control group
Arm Type
Active Comparator
Arm Description
This group receives feature-limited intervention (text-based computerized CBT)
Arm Title
Waitlist control group
Arm Type
Other
Arm Description
This group receives waitlist control.
Intervention Type
Behavioral
Intervention Name(s)
Interactive and full-featured intervention
Intervention Description
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
Intervention Name(s)
Feature-limited CCBT
Intervention Description
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
Other
Intervention Name(s)
Waitlist control
Intervention Description
Participants will be put on a waitlist for a period of 6 weeks.
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire-9 score
Description
Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome.
Time Frame
change from baseline to program completion or last usage (upto 90 days).
Secondary Outcome Measure Information:
Title
Change in Generalized Anxiety Disorder 7 score
Description
Standard questionnaire for generalized anxiety symptoms. Total score is used; lower score indicates better outcome.
Time Frame
baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion
Title
Time spent with the program
Description
Automated measure of time spent on the program for experimental and active comparator group
Time Frame
from beginning till study completion date (expected within 1 year from the trial start date)
Title
Follow-up Patient Health Questionnaire-9 score
Description
Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome.
Time Frame
90-120 days after program completion
Other Pre-specified Outcome Measures:
Title
Change in Patient Health Questionnaire-9 score (Intermediate reports)
Description
Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome.
Time Frame
after modules 1 (average 1 week), 2 (average 2 weeks), 3 (average 3 weeks), 4 (average 4 weeks) and 5 (average 5 weeks)
Title
Change in Generalized Anxiety Disorder 7 score (Intermediate reports)
Description
Standard questionnaire for generalized anxiety symptoms. Total score is used; lower score indicates better outcome.
Time Frame
after modules 1 (average 1 week), 2 (average 2 weeks), 3 (average 3 weeks), 4 (average 4 weeks) and 5 (average 5 weeks)
Title
User experience survey
Description
Computerized survey to get user feedback on the features of the program.
Time Frame
after module 3 (average 3 weeks) and module 6 (upto 90 days) of program
Title
Time spent in playing games
Description
Measurement of the total time for which games are played (in seconds).
Time Frame
from beginning till study completion date (expected within 1 year from the trial start date)
Title
Frequency of playing games
Description
The total number of times for which the games were played
Time Frame
from beginning till study completion date (expected within 1 year from the trial start date)
Title
Feedback on the games
Description
The number of upvotes and downvotes received on games.
Time Frame
from beginning till study completion date (expected within 1 year from the trial start date)
Title
Change in mood during the program
Description
Users in the experimental group, using the chatbot, will indicate their mood in one of the three categories: positive, neutral, and negative.
Time Frame
from beginning till study completion date (expected within 1 year from the trial start date)
Title
Change in completion of worksheets
Description
Automated measure of number of worksheets completed for experimental and active comparator group.
Time Frame
from beginning till study completion date (expected within 1 year from the trial start date)
Title
Use of personalization in the chatbot
Description
The number of times the users change their preferred frequencies of modules in the chatbot.
Time Frame
from beginning till study completion date (expected within 1 year from the trial start date)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nitin Gupta, PhD
Phone
+91-512-679-4384
Email
guptan@iitk.ac.in
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nitin Gupta, PhD
Organizational Affiliation
Indian Institute of Technology Kanpur
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indian Institute of Technology Kanpur
City
Kanpur
State/Province
Uttar Pradesh
ZIP/Postal Code
208016
Country
India
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28254959
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.
Results Reference
background
PubMed Identifier
29422409
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.
Results Reference
background
Links:
URL
https://www.treadwill.org/iitk
Description
Link for TreadWill study
Learn more about this trial
TreadWill, an Automated Intervention for Depressive Symptoms
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