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Automated and Personalized Cognitive Behavioral Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03445598
Recruitment Status : Completed
First Posted : February 26, 2018
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Nitin Gupta, Indian Institute of Technology Kanpur

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.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Behavioral: Interactive and personalized CCBT Behavioral: Feature-limited CCBT Other: Waitlist control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes 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.
Primary Purpose: Supportive Care
Official Title: A Novel and Adaptive Software for Automated Delivery of Cognitive Behavioral Therapy
Actual Study Start Date : February 14, 2018
Actual Primary Completion Date : March 2, 2019
Actual Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interactive CCBT group
This group receives Interactive and Personalized CCBT
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

Active Comparator: Limited CCBT control group
This group receives Feature-limited CCBT
Behavioral: 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.

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445598


Locations
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India
Indian Institute of Technology Kanpur
Kanpur, Uttar Pradesh, India, 208016
Sponsors and Collaborators
Indian Institute of Technology Kanpur
Investigators
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Principal Investigator: Nitin Gupta, PhD Indian Institute of Technology Kanpur
Additional Information:
Publications:
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Responsible Party: Nitin Gupta, Assistant Professor, Indian Institute of Technology Kanpur
ClinicalTrials.gov Identifier: NCT03445598    
Other Study ID Numbers: IITK/NG/CBT1
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nitin Gupta, Indian Institute of Technology Kanpur:
depression
anxiety
CBT
psychotherapy
e-health
CCBT
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms