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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interactive CCBT group | Experimental | This group receives Interactive and Personalized CCBT |
|
| Limited CCBT control group | Active Comparator | This group receives Feature-limited CCBT |
|
| Waitlist control group | Other | This group receives waitlist control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interactive and personalized CCBT | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time spent with the program |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Change in Generalized Anxiety Disorder 7 score (Intermediate reports) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nitin Gupta, PhD | Indian Institute of Technology Kanpur | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indian Institute of Technology Kanpur | Kanpur | Uttar Pradesh | 208016 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28254959 | Background | 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. | |
| 26559241 |
| Label | URL |
|---|---|
| Online recruitment page | View source |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004347 | Drug Interactions |
| ID | Term |
|---|---|
| D000069437 | Pharmacological Phenomena |
| D002620 | Pharmacological and Toxicological Phenomena |
| D010829 | Physiological Phenomena |
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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.
| Feature-limited CCBT | Behavioral | 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 | Other | Participants will be put on a waitlist for a period of 6 weeks. |
|
Automated measure of time spent on the program for experimental and active comparator group |
| 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. | 90 days after program completion |
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) |
| 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 |
| 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 |
| 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 |
| Background |
| 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. |
| 37099376 | Derived | Ghosh A, Cherian RJ, Wagle S, Sharma P, Kannan KR, Bajpai A, Gupta N. An Unguided, Computerized Cognitive Behavioral Therapy Intervention (TreadWill) in a Lower Middle-Income Country: Pragmatic Randomized Controlled Trial. J Med Internet Res. 2023 Apr 26;25:e41005. doi: 10.2196/41005. |