NCT03445598

Automated and Personalized Cognitive Behavioral Therapy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Indian Institute of Technology Kanpur · Academic / Other
• Sex: All
• Age: 16 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Depressive Symptoms

Interventions

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

Timeline

• Start date: 2018-02-14
• Primary completion: 2019-03-02
• Completion: 2019-05-31
• First posted: 2018-02-26
• Last updated: 2019-07-02

Locations

1 site across 1 country: India