Automated and Personalized Cognitive Behavioral Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-14

Study Completion Date

2019-05-31

Brief Summary

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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.

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Detailed Description

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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

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Depressive Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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Interactive CCBT group

This group receives Interactive and Personalized CCBT

Group Type EXPERIMENTAL

Interactive and personalized CCBT

Intervention Type BEHAVIORAL

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

Limited CCBT control group

This group receives Feature-limited CCBT

Group Type ACTIVE_COMPARATOR

Feature-limited CCBT

Intervention Type BEHAVIORAL

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.

Waitlist control group

This group receives waitlist control

Group Type OTHER

Waitlist control

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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.

Intervention Type BEHAVIORAL

Waitlist control

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No