Clinical trial NCT03445598: Automated and Personalized Cognitive Behavioral Therapy
Official title: A Novel and Adaptive Software for Automated Delivery of Cognitive Behavioral Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Keywords: depression
anxiety
CBT
psychotherapy
e-health
CCBT
Lead sponsor: Indian Institute of Technology Kanpur
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 600
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Patient Health Questionnaire-9 score
timeFrame: change from baseline to program completion or last usage (upto 90 days).
Secondary outcomes:
measure: Change in Generalized Anxiety Disorder 7 score
timeFrame: baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion
measure: Time spent with the program
timeFrame: from beginning till last usage (upto 180 days)
measure: Follow-up Patient Health Questionnaire-9 score
timeFrame: 90 days after program completion
Other outcomes:
measure: Change in Patient Health Questionnaire-9 score (Intermediate reports)
timeFrame: after modules 1 (average 1 week), 2 (average 2 weeks), 3 (average 3 weeks), 4 (average 4 weeks) and 5 (average 5 weeks)
measure: Change in Generalized Anxiety Disorder 7 score (Intermediate reports)
timeFrame: after modules 1 (average 1 week), 2 (average 2 weeks), 3 (average 3 weeks), 4 (average 4 weeks) and 5 (average 5 weeks)
measure: User experience survey
timeFrame: after module 3 (average 3 weeks) and module 6 (upto 90 days) of program
measure: Change in Patient Health Questionnaire-9 score (for clinician-referred participants)
timeFrame: baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion
measure: Change in Generalized Anxiety Disorder 7 score (for clinician-referred participants)
timeFrame: baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion
Locations:
city: Kanpur
country: India
facility: Indian Institute of Technology Kanpur
state: Uttar Pradesh
Study officials:
affiliation: Indian Institute of Technology Kanpur
name: Nitin Gupta, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.