Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03445598
Other study ID # IITK/NG/CBT1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT02909387 - Adapting Project UPLIFT for Blacks in Georgia N/A
Completed NCT05702086 - Making SPARX Fly in Nunavut: Pilot Testing an E-intervention for Boosting Resilience Against Youth Depression N/A
Terminated NCT04921332 - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD N/A
Completed NCT03535805 - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances N/A
Recruiting NCT06100146 - Effectiveness of Fortification With Folic Acid and Vitamin B12 Among Teenage Girls N/A
Recruiting NCT03272230 - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System N/A
Completed NCT03514355 - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms N/A
Completed NCT05376397 - Testing THRIVE 365 for Black Sexual Minority Men (On The Daily) N/A
Terminated NCT04367636 - The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19 N/A
Completed NCT04403126 - To Increase Psychological Well-being by the Implementation of Forgiveness Education N/A
Recruiting NCT05078424 - Cognitive Behavioural Therapy for Youths With Depressive and Anxiety Symptoms in Hong Kong N/A
Recruiting NCT06053775 - Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Related to Breast Cancer (ONCODEP) N/A
Active, not recruiting NCT04084795 - Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia N/A
Recruiting NCT04082052 - Evaluating and Predicting Response to a Single Session Intervention for Self-Dislike N/A
Completed NCT04011540 - Digital Data in Mental Health Therapy N/A
Not yet recruiting NCT06413849 - Telephone-coached "Graphic Narrative" Bibliotherapy for Dementia Caregivers N/A
Not yet recruiting NCT03659591 - Triple Aim Psychotherapy: Aimed at Improving Patient Experience, Population Health, and Cost N/A
Not yet recruiting NCT02133170 - "Mindfulness vs Psychoeducation in Bipolar Disorder" N/A
Completed NCT02314390 - Group- Versus Individual-Mindfulness-Based Cognitive Therapy: a Randomized Trial N/A
Completed NCT01628016 - The Effect of Attention Bias Modification Training on Reducing Depressive Symptoms N/A

External Links