An interventional study of Interactive and personalized CCBT and Feature-limited CCBT in Depressive Symptoms, sponsored by Indian Institute of Technology Kanpur. Completed at 1 site in India. Open to participants aged 16 Years to 35 Years. Per ClinicalTrials.gov, last updated 2019-07-02.
Sponsored by Indian Institute of Technology Kanpur · Not applicable, Interventional, and Supportive care
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Among 59 studies in Depression with a site in India — 6 open to participants now, 7 under way, 1 of them phase 3. Depression · India.
Among the 59 studies in Depression with a site in India, this one is the 16th largest by enrollment of the 55 interventional ones that give a count, is one of 3 that started in 2018, is one of 35 with no phase, and was the 29th registered.
8,582 studies on the registry are indexed under Depression; 1,723 are open to participants now.
Browse Depression studies →6 of the 59 studies in Depression with a site in India are open now. Recruiting first, the newest first:
National Bureau of Economic Research, Inc. · Sites in India
Ages 55+ · Women only · Healthy volunteers
Aditi Bunker · Sites in India, Burkina Faso, Fiji and 2 more countries
Ages 18+ · Healthy volunteers
Coventry University · Sites in India
Ages 18–60 · Healthy volunteers
University of North Carolina, Chapel Hill · Sites in India
Ages 13+
University of Oxford · Sites in India
Ages 18–45 · Women only · Healthy volunteers
A study can be open while its sites in India have not opened yet or have stopped. Only those recruiting at a site in India →
Of the 1,089 Depression studies recruiting now, 470 (43%) set no upper age limit and 519 (48%) stop at 75 or younger; 203 take children under 18; 311 take healthy volunteers.
This study: 16 Years to 35 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
59 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 6 · Phase 3 13 · Phase 4 1
First in 2004; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 600 is above the median of 81 across 7,066 interventional studies indexed under Depression.
Median enrollment 319 across the 55 interventional studies, 1,479 across the 4 observational. Of the 49 that completed or were terminated, 16 (33%) have results posted.
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17 of 59 have an industry lead sponsor. The 10 most frequent:
Indian Institute of Technology Kanpur is the lead sponsor of 3 studies on the registry; none are open to participants now.
Indian Institute of Technology Kanpur has 2 studies filed under Depression — fewer than ten, so there is no comparison to draw.
2 of the studies in Depression with a site in India that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06248203University of North Carolina, Chapel HillTeachers Leading the Front Lines - Adolescent | 2027-02-01 |
| NCT06579950Aditi BunkerAssessing the Effects of Cool Roofs on Indoor Environments and Health | 2027-09-30 |
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Among the 59 studies in Depression with a site in India, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This group receives Interactive and Personalized CCBT
Behavioral: Interactive and personalized CCBT
This group receives Feature-limited CCBT
Behavioral: Feature-limited CCBT
This group receives waitlist control
Other: Waitlist control
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
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.
Participants will be put on a waitlist for a period of 6 weeks.
Change in Patient Health Questionnaire-9 score
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).
Change in Generalized Anxiety Disorder 7 score
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
Time spent with the program
Automated measure of time spent on the program for experimental and active comparator group
Time frame: from beginning till last usage (upto 180 days)
Follow-up Patient Health Questionnaire-9 score
Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome.
Time frame: 90 days after program completion
Change in Patient Health Questionnaire-9 score (Intermediate reports)
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)
Change in Generalized Anxiety Disorder 7 score (Intermediate reports)
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)
User experience survey
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
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.
Time frame: baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion
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.
Time frame: baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion
Ran from Feb 2018 to primary completion in Mar 2019, 12 months.
Of 3,471 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 12 months is below that.
Counting every sponsor, half of 3,569 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Indian Institute of Technology Kanpur