Automated and Personalized Cognitive Behavioral Therapy

Indian Institute of Technology Kanpur

Status: Completed

Conditions: Depressive Symptoms

Treatments: Other: Waitlist control; Behavioral: Feature-limited CCBT; Behavioral: Interactive and personalized CCBT

Study type: Interventional

Funder types: Other

Identifiers

NCT03445598

IITK/NG/CBT1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 patients

Sex: All

Ages: 16 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 3 patient groups

Interactive CCBT group

Experimental group

Description:

This group receives Interactive and Personalized CCBT

Treatment:

Behavioral: Interactive and personalized CCBT

Limited CCBT control group

Active Comparator group

Description:

This group receives Feature-limited CCBT

Treatment:

Behavioral: Feature-limited CCBT

Waitlist control group

Other group

Description:

This group receives waitlist control

Treatment:

Other: Waitlist control