Depressive Symptoms
Conditions
Keywords
depression, anxiety, CBT, psychotherapy, e-health, CCBT
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.
Interventions
BEHAVIORALInteractive 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
BEHAVIORALFeature-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.
OTHERWaitlist control
Participants will be put on a waitlist for a period of 6 weeks.
Sponsors
Indian Institute of Technology Kanpur
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, 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.
Eligibility
Sex/Gender
ALL
Age
16 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Health Questionnaire-9 score | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Generalized Anxiety Disorder 7 score | 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. |
| Time spent with the program | from beginning till last usage (upto 180 days) | Automated measure of time spent on the program for experimental and active comparator group |
| Follow-up Patient Health Questionnaire-9 score | 90 days after program completion | Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Health Questionnaire-9 score (Intermediate reports) | 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. |
| Change in Generalized Anxiety Disorder 7 score (for clinician-referred participants) | 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. |
| Change in Generalized Anxiety Disorder 7 score (Intermediate reports) | 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. |
| User experience survey | 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 |
| Change in Patient Health Questionnaire-9 score (for clinician-referred participants) | 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. |
Countries
India
Outcome results
None listed