Automated and Personalized Cognitive Behavioral Therapy

Depressive Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03445598
• Other study ID #: IITK/NG/CBT1
• Status: Completed
• Phase: N/A
• Start date: February 14, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: June 2019
• Source: Indian Institute of Technology Kanpur
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: May 31, 2019
• Est. primary completion date: March 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

Behavioral:
• 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
• 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.

Other:
• Waitlist control
Participants will be put on a waitlist for a period of 6 weeks.

Locations

Country	Name	City	State
India	Indian Institute of Technology Kanpur	Kanpur	Uttar Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Indian Institute of Technology Kanpur

Country where clinical trial is conducted

India, 

References & Publications (2)

Gilbody S, Brabyn S, Lovell K, Kessler D, Devlin T, Smith L, Araya R, Barkham M, Bower P, Cooper C, Knowles S, Littlewood E, Richards DA, Tallon D, White D, Worthy G; REEACT collaborative. Telephone-supported computerised cognitive-behavioural therapy: REEACT-2 large-scale pragmatic randomised controlled trial. Br J Psychiatry. 2017 May;210(5):362-367. doi: 10.1192/bjp.bp.116.192435. Epub 2017 Mar 2. — View Citation

Gilbody S, Littlewood E, Hewitt C, Brierley G, Tharmanathan P, Araya R, Barkham M, Bower P, Cooper C, Gask L, Kessler D, Lester H, Lovell K, Parry G, Richards DA, Andersen P, Brabyn S, Knowles S, Shepherd C, Tallon D, White D; REEACT Team. Computerised cognitive behaviour therapy (cCBT) as treatment for depression in primary care (REEACT trial): large scale pragmatic randomised controlled trial. BMJ. 2015 Nov 11;351:h5627. doi: 10.1136/bmj.h5627. Erratum in: BMJ. 2016;352:i195. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Patient Health Questionnaire-9 score (Intermediate reports)	Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome.	after modules 1 (average 1 week), 2 (average 2 weeks), 3 (average 3 weeks), 4 (average 4 weeks) and 5 (average 5 weeks)
Other	Change in Generalized Anxiety Disorder 7 score (Intermediate reports)	Standard questionnaire for generalized anxiety symptoms. Total score is used; lower score indicates better outcome.	after modules 1 (average 1 week), 2 (average 2 weeks), 3 (average 3 weeks), 4 (average 4 weeks) and 5 (average 5 weeks)
Other	User experience survey	Computerized survey to get user feedback on the features of the program	after module 3 (average 3 weeks) and module 6 (upto 90 days) of program
Other	Change in Patient Health Questionnaire-9 score (for clinician-referred participants)	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.	baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion
Other	Change in Generalized Anxiety Disorder 7 score (for clinician-referred participants)	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.	baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion
Primary	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	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
Secondary	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)
Secondary	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

External Links

•   Online recruitment page