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OpenTrials
Completed

NCT Number: NCT03445598

Automated and Personalized Cognitive Behavioral Therapy

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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Key information

Conditions

Depressive Symptoms Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

16 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indian Institute of Technology Kanpur

Kanpur, Uttar Pradesh, 208016, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interactive and personalized CCBT

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

Feature-limited CCBT

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

Other

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

Primary outcomes

  1. Change in Patient Health Questionnaire-9 score

    Time frame: 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 outcomes

  1. Change in Generalized Anxiety Disorder 7 score

    Time frame: 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.

  2. Time spent with the program

    Time frame: from beginning till last usage (upto 180 days)

    Automated measure of time spent on the program for experimental and active comparator group

  3. Follow-up Patient Health Questionnaire-9 score

    Time frame: 90 days after program completion

    Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome.

Other outcomes

  1. Change in Patient Health Questionnaire-9 score (Intermediate reports)

    Time frame: after modules 1 (average 1 week), 2 (average 2 weeks), 3 (average 3 weeks), 4 (average 4 weeks) and 5 (average 5 weeks)

    Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome.

  2. Change in Generalized Anxiety Disorder 7 score (Intermediate reports)

    Time frame: after modules 1 (average 1 week), 2 (average 2 weeks), 3 (average 3 weeks), 4 (average 4 weeks) and 5 (average 5 weeks)

    Standard questionnaire for generalized anxiety symptoms. Total score is used; lower score indicates better outcome.

  3. User experience survey

    Time frame: after module 3 (average 3 weeks) and module 6 (upto 90 days) of program

    Computerized survey to get user feedback on the features of the program

  4. Change in Patient Health Questionnaire-9 score (for clinician-referred participants)

    Time frame: baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion

    The subset of participants that are referred to the trial by a clinician can be analyzed separately to test the effectiveness of the program when used with a clinician's referral. Total score is used; lower score indicates better outcome.

  5. Change in Generalized Anxiety Disorder 7 score (for clinician-referred participants)

    Time frame: baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion

    The subset of participants that are referred to the trial by a clinician can be analyzed separately to test the effectiveness of the program when used with a clinician's referral. Total score is used; lower score indicates better outcome.

Sponsors and collaborators

Lead sponsor

Indian Institute of Technology Kanpur

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 26, 2018
Registry last updated
Jul 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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