Mental Health DisordersiCASNCT02023957
A Pilot With Interactive Computer-assisted Screening for Mental Health in Primary Care
A study testing Interactive computer-assisted screening (iCAS) in people with Mental Health Disorders, run by York University at 1 site in Canada.
Trial summary
The current protocol pertains to the evaluation of the interactive computer-assisted screening (iCAS) tool through a pilot randomized control trial. The purpose of this evaluation is to determine the efficacy of the iCAS tool in improving clinician's detection of common mental health conditions (i.e. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Disorders
- What is being tested?
- Interactive computer-assisted screening (iCAS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to May 2014
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Speak/read Spanish
- Speak/read English
- Visiting the consenting clinician
Who cannot join
- Patient accompanied by a family member for interpretation
- New patients coming for first visit
- Patients feeling unwell (self-report)
- Inability of the research staff to offer study details in privacy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interactive Computer-assisted Screening for Mental Health in Primary Care
The current protocol pertains to the evaluation of the interactive computer-assisted screening (iCAS) tool through a pilot randomized control trial. The purpose of this evaluation is to determine the efficacy of the iCAS tool in improving clinician's detection of common mental health conditions (i.e. major depression/generalized anxiety/post-traumatic stress disorder/alcohol dependence), and patients' discussion on mental health.
Read the detailed description
The iCAS tool is a health-risk assessment survey that is completed by adult patients using touch-screen iPad device in their waiting time before seeing their clinician (family physician or nurse practitioner). The computer program generates tailored risk-report for the clinician and a simple recommendation sheet for the patient, with community resources and health information, at the point of care. The iCAS tool currently includes validated screening scales for depression, generalized anxiety, posttraumatic stress disorder and alcohol abuse. There are some questions on the social determinants of mental health as well. The current versions of the tool are in English and Spanish; a Chinese language version will also be developed.
- Conditions
- Mental Health Disorders
- Being tested
- Interactive computer-assisted screening (iCAS)
- Keywords
- Interactive Health-risk assessment, Primary Care, Randomized, Open Label, Efficacy Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive computer-assisted screening (iCAS)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Interactive computer-assisted screening | Experimental | Eligible patients completed the interactive computer-assisted screening (iCAS) tool in English or Spanish before seeing the consenting clinician. Participating patients then received the iCAS generated tailored recommendation sheet. Participating clinicians received the iCAS generated risk report. Receives: Behavioral: Interactive computer-assisted screening (iCAS) |
| Usual Care | No intervention | Eligible patients randomized to the control group completed their standard visit to the participating clinician. There was no pre-visit health risk screening. There were no tailored reports for the patients or clinicians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Detection (probable, sub-clinical, confirmed) of major depression or generalized anxiety or post-traumatic stress disorder or alcohol dependence
Chart review for the index visit
Measured: Day 1
Patient discussion on mental health
Exit Survey of patients after the index visit
Measured: Day 1
Secondary outcomes (4)
Patient intention to see a mental health counselor
Exit Survey of patients after the index visit
Measured: Day 1
Patient satisfaction with health services
Exit Survey of patients after the index visit
Measured: Day 1
Patient enablement to cope with these conditions
Exit Survey of patients after the index visit
Measured: Day 1
Patient adherence to follow-up advice and referrals to mental health support
Chart review
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental Health DisordersStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), North York General Hospital
- Responsible party
- Principal investigator, Farah Ahmad, York University
- Investigators
- Farah Ahmad, PhD, Principal investigator, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023957
- Sponsor's protocol ID
- e2013 - 291
- Acronym
- iCAS
- Status last verified
- Jun 2016
- First submitted
- 12 Dec 2013
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ahmad F, Lou W, Shakya Y, Ginsburg L, Ng PT, Rashid M, Dinca-Panaitescu S, Ledwos C, McKenzie K. Preconsult interactive computer-assisted client assessment survey for common mental disorders in a community health centre: a randomized controlled trial. CMAJ Open. 2017 Mar 1;5(1):E190-E197. doi: 10.9778/cmajo.20160118. eCollection 2017 Jan-Mar.
PubMed 28401134Ferrari M, Ahmad F, Shakya Y, Ledwos C, McKenzie K. Computer-assisted client assessment survey for mental health: patient and health provider perspectives. BMC Health Serv Res. 2016 Sep 23;16(1):516. doi: 10.1186/s12913-016-1756-0.
PubMed 27663508
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Computer-assisted Screening for Mental Health in Primary Care
- ClinicalTrials.gov ID
- NCT02023957
- Acronym / sponsor ID
- iCAS / e2013 - 291
- Conditions
- Mental Health Disorders
- Keywords
- Interactive Health-risk assessment, Primary Care, Randomized, Open Label, Efficacy Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), North York General Hospital
- Study start
- Nov 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 30 Dec 2013 (estimated)
- 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.
The current protocol pertains to the evaluation of the interactive computer-assisted screening (iCAS) tool through a pilot randomized control trial. The purpose of this evaluation is to determine the efficacy of the iCAS tool in improving clinician's detection of common mental health conditions (i.e. major depression/generalized anxiety/post-traumatic stress disorder/alcohol dependence), and patients' discussion on mental health.
Detailed description
The iCAS tool is a health-risk assessment survey that is completed by adult patients using touch-screen iPad device in their waiting time before seeing their clinician (family physician or nurse practitioner). The computer program generates tailored risk-report for the clinician and a simple recommendation sheet for the patient, with community resources and health information, at the point of care. The iCAS tool currently includes validated screening scales for depression, generalized anxiety, posttraumatic stress disorder and alcohol abuse. There are some questions on the social determinants of mental health as well. The current versions of the tool are in English and Spanish; a Chinese language version will also be developed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive computer-assisted screening | Experimental | Behavioral: Interactive computer-assisted screening (iCAS)Eligible patients completed the interactive computer-assisted screening (iCAS) tool in English or Spanish before seeing the consenting clinician. Participating patients then received the iCAS generated tailored recommendation sheet. Participating clinicians received the iCAS generated risk report. |
| Usual Care | No intervention | –Eligible patients randomized to the control group completed their standard visit to the participating clinician. There was no pre-visit health risk screening. There were no tailored reports for the patients or clinicians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age
- Speak/read Spanish
- Speak/read English
- Visiting the consenting clinician
Key exclusion criteria (4 listed)
- Patient accompanied by a family member for interpretation
- New patients coming for first visit
- Patients feeling unwell (self-report)
- Inability of the research staff to offer study details in privacy
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 computer-assisted screening (iCAS) | Behavioural | Interactive computer-assisted screening |
Primary outcome
Clinician Detection (probable, sub-clinical, confirmed) of major depression or generalized anxiety or post-traumatic stress disorder or alcohol dependence
Time frame: Day 1
Chart review for the index visit
Patient discussion on mental health
Time frame: Day 1
Exit Survey of patients after the index visit
4 secondary outcomes
Patient intention to see a mental health counselor
Time frame: Day 1
Patient satisfaction with health services
Time frame: Day 1
Patient enablement to cope with these conditions
Time frame: Day 1
Patient adherence to follow-up advice and referrals to mental health support
Time frame: 3 month
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 3 Jun 2016.
- Derived from this study: PubMed 28401134Ahmad F, Lou W, Shakya Y, Ginsburg L, Ng PT, Rashid M, Dinca-Panaitescu S, Ledwos C, McKenzie K. Preconsult interactive computer-assisted client assessment survey for common mental disorders in a community health centre: a randomized controlled trial. CMAJ Open. 2017 Mar 1;5(1):E190-E197. doi: 10.9778/cmajo.20160118. eCollection 2017 Jan-Mar.
- Derived from this study: PubMed 27663508Ferrari M, Ahmad F, Shakya Y, Ledwos C, McKenzie K. Computer-assisted client assessment survey for mental health: patient and health provider perspectives. BMC Health Serv Res. 2016 Sep 23;16(1):516. doi: 10.1186/s12913-016-1756-0.
- Individual participant dataSharing planned: Undecided
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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.
Farah Ahmad, PhD principal investigator
York University
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 computer-assisted screening (iCAS) in people with Mental Health Disorders, run by York University at 1 site in Canada.
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 3 Jun 2016. 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 Canada. 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?
Clinician Detection (probable, sub-clinical, confirmed) of major depression or generalized anxiety or post-traumatic stress disorder or alcohol dependence (time frame: Day 1). The study lists 2 primary outcomes in all. 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 NCT02023957, which also lists 2 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 3 Jun 2016.