Depressive SymptomsNCT04703491
TreadWill, an Automated Intervention for Depressive Symptoms
A study testing Interactive and full-featured intervention and Feature-limited CCBT in people with Depressive Symptoms, run by Indian Institute of Technology Kanpur at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Interactive and full-featured intervention and Feature-limited CCBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteIndia
- Study dates
- 27 Apr 2021to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Indian Institute of Technology Kanpur
Kanpur, Uttar Pradesh, 208016
About this study
Official title: A Novel and Adaptive Software for Automated Delivery of Cognitive Behavioral Therapy
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.
Read the 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.
- Conditions
- Depressive Symptoms
- Being tested
- Interactive and full-featured intervention, Feature-limited CCBT, Waitlist control
- Keywords
- depression, anxiety, CCBT, CBM, chatbot, CBT, mindfulness
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive and full-featured interventionBehavioural
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.
Feature-limited CCBTBehavioural
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 controlOther
Participants will be put on a waitlist for a period of 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Full intervention | Experimental | This group receives the full-featured intervention, including CCBT, CBM, Mindfulness, chatbot with many interactive elements. Receives: Behavioral: Interactive and full-featured intervention |
| Limited CCBT control group | Active comparator | This group receives feature-limited intervention (text-based computerized CBT) Receives: Behavioral: Feature-limited CCBT |
| Waitlist control group | Other | This group receives waitlist control. Receives: Other: Waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire-9 score
Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome.
Measured: change from baseline to program completion or last usage (upto 90 days).
Secondary outcomes (3)
Change in Generalized Anxiety Disorder 7 score
Standard questionnaire for generalized anxiety symptoms. Total score is used; lower score indicates better outcome.
Measured: baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion
Time spent with the program
Automated measure of time spent on the program for experimental and active comparator group
Measured: 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.
Measured: 90-120 days after program completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start27 Apr 2021
- Primary completionJan 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indian Institute of Technology Kanpur
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nitin Gupta, Indian Institute of Technology Kanpur
- Investigators
- Nitin Gupta, PhD, Principal investigator, Indian Institute of Technology Kanpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703491
- Sponsor's protocol ID
- IITK/IEC/2019-20/II/4
- Status last verified
- May 2021
- First submitted
- 30 Dec 2020
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28254959Andrews 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.
PubMed 29422409
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel and Adaptive Software for Automated Delivery of Cognitive Behavioral Therapy
- ClinicalTrials.gov ID
- NCT04703491
- Acronym / sponsor ID
- IITK/IEC/2019-20/II/4
- Conditions
- Depressive Symptoms
- Keywords
- depression, anxiety, CCBT, CBM, chatbot, CBT, mindfulness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Indian Institute of Technology KanpurUniversity, hospital or other
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full intervention | Experimental | Behavioral: Interactive and full-featured interventionThis group receives the full-featured intervention, including CCBT, CBM, Mindfulness, chatbot with many interactive elements. |
| Limited CCBT control group | Active comparator | Behavioral: Feature-limited CCBTThis group receives feature-limited intervention (text-based computerized CBT) |
| Waitlist control group | Other | Other: Waitlist controlThis group receives waitlist control. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive and full-featured interventionParticipants 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. | Behavioural | Full intervention |
| Feature-limited CCBTParticipants will be going through an automated program. Participants will learn and practice the techniques of CBT in a plain-text format with reduced features | Behavioural | Limited CCBT control group |
| Waitlist controlParticipants will be put on a waitlist for a period of 6 weeks. | Other | Waitlist control group |
Primary outcome
Change in Patient Health Questionnaire-9 score
Time frame: 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.
3 secondary outcomes
Change in Generalized Anxiety Disorder 7 score
Time frame: baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion
Time spent with the program
Time frame: from beginning till study completion date (expected within 1 year from the trial start date)
Follow-up Patient Health Questionnaire-9 score
Time frame: 90-120 days after program completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Background: PubMed 28254959Gilbody 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.
- Background: PubMed 29422409Andrews 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.
- Link for TreadWill studyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nitin Gupta, PhD principal investigator
Indian Institute of Technology Kanpur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive and full-featured intervention and Feature-limited CCBT in people with Depressive Symptoms, run by Indian Institute of Technology Kanpur at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nitin Gupta, PhD (+91-512-679-4384, guptan@iitk.ac.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Health Questionnaire-9 score (time frame: change from baseline to program completion or last usage (upto 90 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04703491, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.