Automated and Personalized Cognitive Behavioral Therapy

Not Applicable

Completed

• Conditions: Depressive Symptoms

• Registration Number: NCT03445598
• Lead Sponsor: Indian Institute of Technology Kanpur

Brief 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.

Study Timeline

• Study Start: 2018-02-14
• Study First Submitted: 2018-02-14
• Study First Submitted QC: 2018-02-20
• Study First Posted: 2018-02-26
• Primary Completion: 2019-03-02
• Study Completion: 2019-05-31
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-30
• Last Update Posted: 2019-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 last usage (upto 180 days)	Automated measure of time spent on the program for experimental and active comparator group
Follow-up Patient Health Questionnaire-9 score	90 days after program completion	Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome.

Trial Locations

Locations (1)

Indian Institute of Technology Kanpur; 🇮🇳 Kanpur, Uttar Pradesh, India