Automated and Personalized Cognitive Behavioral Therapy

June 30, 2019 updated by: Nitin Gupta, Indian Institute of Technology Kanpur

A Novel and Adaptive Software for Automated Delivery of Cognitive Behavioral Therapy

This study is designed to evaluate a novel online tool to deliver computerized Cognitive Behavioral Therapy (CBT). Participants will be randomized into three groups: experimental, active control, and waitlist. Participants in the experimental group will have access to the full-featured online tool designed to deliver CBT in an interactive and personalized manner. The participants in the active control group will have access to a limited version of the online tool designed to deliver basic CBT in plain text format. The waitlisted participants will be put on a waitlist for 6 weeks. We hypothesize that the experimental group participants will show a significantly higher reduction in depression symptom severity and will show increased engagement and adherence to the online tool.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Depression is a major psychiatric disorder globally, including in India. One of the most effective approaches to treat depression is Cognitive Behavioral Therapy (CBT), but its reach is limited by the dearth of trained psychiatrists, especially in remote areas, and the high costs and stigma associated with visits to a psychiatric clinic. Delivering CBT through a computer, with limited or no intervention from a psychiatrist, could address these limitations. Computerized Cognitive Behavioral Therapy (CCBT) is thus emerging as a more accessible and economical alternative to CBT. Despite some evidence of its efficacy, CCBT use is limited because the existing software programs used to deliver the therapy provide a much lower level of personalization and engagement than in-person therapy. The objective of this study is to assess if the new algorithm makes CCBT more efficacious, acceptable and engaging to users. Depression severity as measured by the Patient Health Questionnaire-9 (PHQ-9) is expected to reduce over the duration of the study, more significantly in the treatment group compared to the control group. Participants will be recruited online through a website that will check compatibility with inclusion/exclusion criteria and get the informed consent.

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Uttar Pradesh
      • Kanpur, Uttar Pradesh, India, 208016
        • Indian Institute of Technology Kanpur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Fluent in English
  • PHQ-9 Score from 5 to 19
  • Access to internet-connected computer or tablet device
  • Country: India

Exclusion Criteria:

  • Suicide ideation (score greater than 0 on the 9th question of PHQ-9)
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interactive CCBT group
This group receives Interactive and Personalized CCBT
Behavioral: Interactive and personalized CCBT
Participants will go through an automated program. Participants will learn and practice the techniques of CBT through multimedia elements along with personalized content and interactive features in the program
Active Comparator: Limited CCBT control group
This group receives Feature-limited CCBT
Behavioral: Feature-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.
Other: Waitlist control group
This group receives waitlist control
Other: Waitlist control
Participants will be put on a waitlist for a period of 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
change from baseline to program completion or last usage (upto 90 days).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Generalized Anxiety Disorder 7 score
Time Frame: 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.
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 last usage (upto 180 days)
Automated measure of time spent on the program for experimental and active comparator group
from beginning till last usage (upto 180 days)
Follow-up Patient Health Questionnaire-9 score
Time Frame: 90 days after program completion
Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome.
90 days after program completion

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient Health Questionnaire-9 score (Intermediate reports)
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)
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)
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)
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
Time Frame: 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
after module 3 (average 3 weeks) and module 6 (upto 90 days) of program
Change in Patient Health Questionnaire-9 score (for clinician-referred participants)
Time Frame: baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion
The subset of participants that are referred to the trial by a clinician can be analyzed separately to test the effectiveness of the program when used with a clinician's referral. Total score is used; lower score indicates better outcome.
baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion
Change in Generalized Anxiety Disorder 7 score (for clinician-referred participants)
Time Frame: baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion
The subset of participants that are referred to the trial by a clinician can be analyzed separately to test the effectiveness of the program when used with a clinician's referral. Total score is used; lower score indicates better outcome.
baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indian Institute of Technology Kanpur

Investigators

  • Principal Investigator: Nitin Gupta, PhD, Indian Institute of Technology Kanpur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2018

Primary Completion (Actual)

March 2, 2019

Study Completion (Actual)

May 31, 2019

Study Registration Dates

First Submitted

February 14, 2018

First Submitted That Met QC Criteria

February 20, 2018

First Posted (Actual)

February 26, 2018

Study Record Updates

Last Update Posted (Actual)

July 2, 2019

Last Update Submitted That Met QC Criteria

June 30, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IITK/NG/CBT1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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