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Automated and Personalized Cognitive Behavioral Therapy

Primary Purpose

Depressive Symptoms

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Interactive and personalized CCBT
Feature-limited CCBT
Waitlist control
Sponsored by
Indian Institute of Technology Kanpur
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depressive Symptoms focused on measuring depression, anxiety, CBT, psychotherapy, e-health, CCBT

Eligibility Criteria

16 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Indian Institute of Technology Kanpur

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Interactive CCBT group

Limited CCBT control group

Waitlist control group

Arm Description

This group receives Interactive and Personalized CCBT

This group receives Feature-limited CCBT

This group receives waitlist control

Outcomes

Primary Outcome Measures

Change in Patient Health Questionnaire-9 score
Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome.

Secondary Outcome Measures

Change in Generalized Anxiety Disorder 7 score
Standard questionnaire for generalized anxiety symptoms. Total score is used; lower score indicates better outcome.
Time spent with the program
Automated measure of time spent on the program for experimental and active comparator group
Follow-up Patient Health Questionnaire-9 score
Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome.

Full Information

First Posted
February 14, 2018
Last Updated
June 30, 2019
Sponsor
Indian Institute of Technology Kanpur
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1. Study Identification

Unique Protocol Identification Number
NCT03445598
Brief Title
Automated and Personalized Cognitive Behavioral Therapy
Official Title
A Novel and Adaptive Software for Automated Delivery of Cognitive Behavioral Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 14, 2018 (Actual)
Primary Completion Date
March 2, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indian Institute of Technology Kanpur

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms
Keywords
depression, anxiety, CBT, psychotherapy, e-health, CCBT

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interactive CCBT group
Arm Type
Experimental
Arm Description
This group receives Interactive and Personalized CCBT
Arm Title
Limited CCBT control group
Arm Type
Active Comparator
Arm Description
This group receives Feature-limited CCBT
Arm Title
Waitlist control group
Arm Type
Other
Arm Description
This group receives waitlist control
Intervention Type
Behavioral
Intervention Name(s)
Interactive and personalized CCBT
Intervention Description
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
Intervention Name(s)
Feature-limited CCBT
Intervention Description
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
Other
Intervention Name(s)
Waitlist control
Intervention Description
Participants will be put on a waitlist for a period of 6 weeks.
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire-9 score
Description
Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome.
Time Frame
change from baseline to program completion or last usage (upto 90 days).
Secondary Outcome Measure Information:
Title
Change in Generalized Anxiety Disorder 7 score
Description
Standard questionnaire for generalized anxiety symptoms. Total score is used; lower score indicates better outcome.
Time Frame
baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion
Title
Time spent with the program
Description
Automated measure of time spent on the program for experimental and active comparator group
Time Frame
from beginning till last usage (upto 180 days)
Title
Follow-up Patient Health Questionnaire-9 score
Description
Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome.
Time Frame
90 days after program completion
Other Pre-specified Outcome Measures:
Title
Change in Patient Health Questionnaire-9 score (Intermediate reports)
Description
Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome.
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)
Title
Change in Generalized Anxiety Disorder 7 score (Intermediate reports)
Description
Standard questionnaire for generalized anxiety symptoms. Total score is used; lower score indicates better outcome.
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)
Title
User experience survey
Description
Computerized survey to get user feedback on the features of the program
Time Frame
after module 3 (average 3 weeks) and module 6 (upto 90 days) of program
Title
Change in Patient Health Questionnaire-9 score (for clinician-referred participants)
Description
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.
Time Frame
baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion
Title
Change in Generalized Anxiety Disorder 7 score (for clinician-referred participants)
Description
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.
Time Frame
baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nitin Gupta, PhD
Organizational Affiliation
Indian Institute of Technology Kanpur
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indian Institute of Technology Kanpur
City
Kanpur
State/Province
Uttar Pradesh
ZIP/Postal Code
208016
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
28254959
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.
Results Reference
background
PubMed Identifier
26559241
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.
Results Reference
background
Links:
URL
https://www.treadwill.org/iitk
Description
Online recruitment page

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Automated and Personalized Cognitive Behavioral Therapy

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