Depressive Symptoms
Conditions
Keywords
depression, anxiety, CCBT, CBM, chatbot, CBT, mindfulness
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.
Interventions
BEHAVIORALInteractive 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.
BEHAVIORALFeature-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
OTHERWaitlist control
Participants will be put on a waitlist for a period of 6 weeks.
Sponsors
Indian Institute of Technology Kanpur
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Health Questionnaire-9 score | change from baseline to program completion or last usage (upto 90 days). | Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Generalized Anxiety Disorder 7 score | baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion | Standard questionnaire for generalized anxiety symptoms. Total score is used; lower score indicates better outcome. |
| Time spent with the program | from beginning till study completion date (expected within 1 year from the trial start date) | Automated measure of time spent on the program for experimental and active comparator group |
| Follow-up Patient Health Questionnaire-9 score | 90-120 days after program completion | Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Frequency of playing games | from beginning till study completion date (expected within 1 year from the trial start date) | The total number of times for which the games were played |
| Feedback on the games | from beginning till study completion date (expected within 1 year from the trial start date) | The number of upvotes and downvotes received on games. |
| Change in Patient Health Questionnaire-9 score (Intermediate reports) | after modules 1 (average 1 week), 2 (average 2 weeks), 3 (average 3 weeks), 4 (average 4 weeks) and 5 (average 5 weeks) | Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome. |
| Change in completion of worksheets | from beginning till study completion date (expected within 1 year from the trial start date) | Automated measure of number of worksheets completed for experimental and active comparator group. |
| Use of personalization in the chatbot | from beginning till study completion date (expected within 1 year from the trial start date) | The number of times the users change their preferred frequencies of modules in the chatbot. |
| Change in mood during the program | from beginning till study completion date (expected within 1 year from the trial start date) | Users in the experimental group, using the chatbot, will indicate their mood in one of the three categories: positive, neutral, and negative. |
| Change in Generalized Anxiety Disorder 7 score (Intermediate reports) | after modules 1 (average 1 week), 2 (average 2 weeks), 3 (average 3 weeks), 4 (average 4 weeks) and 5 (average 5 weeks) | Standard questionnaire for generalized anxiety symptoms. Total score is used; lower score indicates better outcome. |
| User experience survey | after module 3 (average 3 weeks) and module 6 (upto 90 days) of program | Computerized survey to get user feedback on the features of the program. |
| Time spent in playing games | from beginning till study completion date (expected within 1 year from the trial start date) | Measurement of the total time for which games are played (in seconds). |
Countries
India
Contacts
Primary ContactNitin Gupta, PhD
Outcome results
None listed