NCT04703491

Brief Summary

TreadWill is a fully automated digital intervention that provides a multi-modal treatment for depressive symptoms. It includes:

  1. 1.Slides and interactive text-based conversations based on Cognitive Behavioral Therapy (CBT);
  2. 2.Mindfulness videos;
  3. 3.Game-based Cognitive Bias Modification paradigms;
  4. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 30, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

April 27, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

May 4, 2021

Status Verified

May 1, 2021

Enrollment Period

8 months

First QC Date

December 30, 2020

Last Update Submit

May 3, 2021

Conditions

Depressive Symptoms

Keywords

depressionanxietyCCBTCBMchatbotCBTmindfulness

Outcome Measures

Primary Outcomes (1)

  • 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).

Secondary Outcomes (3)

  • Change in Generalized Anxiety Disorder 7 score

    baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion

  • Time spent with the program

    from beginning till study completion date (expected within 1 year from the trial start date)

  • Follow-up Patient Health Questionnaire-9 score

    90-120 days after program completion

Other Outcomes (9)

  • 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)

  • 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)

  • User experience survey

    after module 3 (average 3 weeks) and module 6 (upto 90 days) of program

  • +6 more other outcomes

Study Arms (3)

Full intervention

EXPERIMENTAL

This group receives the full-featured intervention, including CCBT, CBM, Mindfulness, chatbot with many interactive elements.

Behavioral: Interactive and full-featured intervention

Limited CCBT control group

ACTIVE COMPARATOR

This group receives feature-limited intervention (text-based computerized CBT)

Behavioral: Feature-limited CCBT

Waitlist control group

OTHER

This group receives waitlist control.

Other: Waitlist control

Interventions

Interactive and full-featured interventionBEHAVIORAL

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.

Full intervention
Feature-limited CCBTBEHAVIORAL

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

Limited CCBT control group
Waitlist controlOTHER

Participants will be put on a waitlist for a period of 6 weeks.

Waitlist control group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indian Institute of Technology Kanpur

Kanpur, Uttar Pradesh, 208016, India

RECRUITING

Related Publications (2)

  • 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.

    PMID: 28254959BACKGROUND

  • 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.

    PMID: 29422409BACKGROUND

Related Links

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Drug Interactions

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Pharmacological PhenomenaPharmacological and Toxicological PhenomenaPhysiological Phenomena

Study Officials

  • Nitin Gupta, PhD

    Indian Institute of Technology Kanpur

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nitin Gupta, PhD

CONTACT

+91-512-679-4384guptan@iitk.ac.in

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 30, 2020

First Posted

January 11, 2021

Study Start

April 27, 2021

Primary Completion

January 1, 2022

Study Completion

April 1, 2022

Last Updated

May 4, 2021

Record last verified: 2021-05

Locations

IN(1)