Automated and Personalized Cognitive Behavioral Therapy

Study Overview
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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.

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.

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

Conditions
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Depressive Symptoms

Intervention / Treatment
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* Behavioral: Interactive and personalized CCBT
* Behavioral: Feature-limited CCBT
* Other: Waitlist control


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interactive CCBT group<br>This group receives Interactive and Personalized CCBT | Behavioral: Interactive and personalized CCBT<br>* 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<br>|
| Active Comparator: Limited CCBT control group<br>This group receives Feature-limited CCBT | Behavioral: Feature-limited CCBT<br>* 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.<br>|
| Other: Waitlist control group<br>This group receives waitlist control | Other: Waitlist control<br>* Participants will be put on a waitlist for a period of 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Health Questionnaire-9 score | 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 | 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 | 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 | Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome. | 90 days after program completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CBT, depression, anxiety, psychotherapy, e-health, CCBT