Depressive SymptomsNCT03445598
Automated and Personalized Cognitive Behavioral Therapy
A study testing Interactive and personalized CCBT and Feature-limited CCBT in people with Depressive Symptoms, run by Indian Institute of Technology Kanpur at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Interactive and personalized CCBT and Feature-limited CCBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteIndia
- Study dates
- 14 Feb 2018to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Fluent in English
- PHQ-9 Score from 5 to 19
- Access to internet-connected computer or tablet device
- Country: India
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel and Adaptive Software for Automated Delivery of Cognitive Behavioral Therapy
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.
Read the 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.
- Conditions
- Depressive Symptoms
- Being tested
- Interactive and personalized CCBT, Feature-limited CCBT, Waitlist control
- Keywords
- depression, anxiety, CBT, psychotherapy, e-health, CCBT
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive and personalized CCBTBehavioural
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 CCBTBehavioural
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 controlOther
Participants will be put on a waitlist for a period of 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Interactive CCBT group | Experimental | This group receives Interactive and Personalized CCBT Receives: Behavioral: Interactive and personalized CCBT |
| Limited CCBT control group | Active comparator | This group receives Feature-limited CCBT Receives: Behavioral: Feature-limited CCBT |
| Waitlist control group | Other | This group receives waitlist control Receives: Other: Waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire-9 score
Standard questionnaire for depressive symptoms. Total score is used; lower score indicates better outcome.
Measured: change from baseline to program completion or last usage (upto 90 days).
Secondary outcomes (3)
Change in Generalized Anxiety Disorder 7 score
Standard questionnaire for generalized anxiety symptoms. Total score is used; lower score indicates better outcome.
Measured: 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
Measured: 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.
Measured: 90 days after program completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start14 Feb 2018
- Primary completion2 Mar 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indian Institute of Technology Kanpur
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nitin Gupta, Indian Institute of Technology Kanpur
- Investigators
- Nitin Gupta, PhD, Principal investigator, Indian Institute of Technology Kanpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445598
- Sponsor's protocol ID
- IITK/NG/CBT1
- Status last verified
- Jun 2019
- First submitted
- 14 Feb 2018
- Last updated
- 2 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28254959Gilbody 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.
PubMed 26559241Ghosh 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.
PubMed 37099376
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel and Adaptive Software for Automated Delivery of Cognitive Behavioral Therapy
- ClinicalTrials.gov ID
- NCT03445598
- Acronym / sponsor ID
- IITK/NG/CBT1
- Conditions
- Depressive Symptoms
- Keywords
- depression, anxiety, CBT, psychotherapy, e-health, CCBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Indian Institute of Technology KanpurUniversity, hospital or other
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 2 Mar 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Interactive CCBT group | Experimental | Behavioral: Interactive and personalized CCBTThis group receives Interactive and Personalized CCBT |
| Limited CCBT control group | Active comparator | Behavioral: Feature-limited CCBTThis group receives Feature-limited CCBT |
| Waitlist control group | Other | Other: Waitlist controlThis group receives waitlist control |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Fluent in English
- PHQ-9 Score from 5 to 19
- Access to internet-connected computer or tablet device
- Country: India
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive and personalized CCBTParticipants 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 | Behavioural | Interactive CCBT group |
| Feature-limited CCBTParticipants will be going through an automated program. Participants will learn and practice the techniques of CBT in a plain-text format with reduced features. | Behavioural | Limited CCBT control group |
| Waitlist controlParticipants will be put on a waitlist for a period of 6 weeks. | Other | Waitlist control group |
Primary outcome
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.
3 secondary outcomes
Change in Generalized Anxiety Disorder 7 score
Time frame: baseline, post-completion or last usage (upto 90 days), 90 day follow-up after completion
Time spent with the program
Time frame: from beginning till last usage (upto 180 days)
Follow-up Patient Health Questionnaire-9 score
Time frame: 90 days after program completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
- Background: PubMed 28254959Gilbody 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.
- Background: PubMed 26559241Gilbody 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.
- Derived from this study: PubMed 37099376Ghosh 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.
- Online recruitment pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nitin Gupta, PhD principal investigator
Indian Institute of Technology Kanpur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive and personalized CCBT and Feature-limited CCBT in people with Depressive Symptoms, run by Indian Institute of Technology Kanpur at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Health Questionnaire-9 score (time frame: change from baseline to program completion or last usage (upto 90 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03445598, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.