Major Depressive DisordereCARIBOUNCT05086120
A Remote Electronically Delivered Integrated Care Pathway: A Feasibility Study
A study testing eCARIBOU in people with Major Depressive Disorder, run by Centre for Addiction and Mental Health at 2 sites in Canada.
Trial summary
This is a one-armed observational study and feasibility trial of a remote electronically-delivered integrated care pathway for the treatment of adolescents. Eligible participants are between the ages of 13 and 18, inclusive, who have a primary diagnosis of major depressive disorder. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- eCARIBOU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 2 sitesCanada
- Study dates
- 4 Jan 2023to 23 Jan 2024
- 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 13-18 years old at baseline
- Mood and Feelings Questionnaire - Childhood, long version (MFQ) score of ≥22
- Diagnosis of Major Depressive Disorder by impression from the referring psychiatrist and confirmed using the KSADS
- Internet access at home
- Access to a smartphone for personal and private use, with an associated standard data plan (ie. greater than or equal to 500 MB/month)
- Able to speak and read English fluently
Who cannot join
- Individuals that arecurrently receiving structured psychotherapy
- Clinically significant suicidal ideation that is defined as 'imminent intent' or attempted suicide in the past 6 months
- Co-morbid diagnosis of borderline personality disorder (as assessed by the Childhood Interview for Borderline Personality Disorder) (Zanarini, 2003), schizophrenia, bipolar disorder, moderate-to-severe eating disorder, obsessive compulsive disorder and/or severe alcohol/substance use disorder in the past 3 months
- Youth with known or clinically suspected intellectual disability or autism spectrum disorder
- Youth who are not able to provide informed consent for any other reason
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The Center for Addiction and Mental Health
Toronto, Ontario, M6J 1H4
Centre for Addiction and Mental Health
Toronto, Ontario
About this study
Official title: A Remote Electronically Delivered Integrated Care Pathway for Adolescents With Major Depressive Disorder: A Feasibility Study
This is a one-armed observational study and feasibility trial of a remote electronically-delivered integrated care pathway for the treatment of adolescents. Eligible participants are between the ages of 13 and 18, inclusive, who have a primary diagnosis of major depressive disorder. Outcomes of interest are recruitment rates and participation in pathway components, including: appointments, measure-completion and use of electronically-delivered cognitive behavioural therapy.
Read the detailed description
Introduction: Depression is common and debilitating in the adolescent age range. Geography or other logistical barriers may prevent youth from accessing care. Progress in the treatment of youth that uses their tendencies to engage in electronically mediated contacts (e.g., text, online videos, and livestream video chat) can strategically address depressive disorders to overcome these barriers.
Methods: The Principal Investigator will conduct a pilot single-arm trial to assess the feasibility of a 16-week remote electronically delivered integrated care pathway (ICP) for the treatment of adolescents (age 13-18) with major depressive disorder. CBT components being delivered has been tested in the age 18-30 with depression. The ICP includes: tele-psychiatry appointments, online measurement-based care, internet-based cognitive behavioural therapy combined with mindfulness training, and text-based health coaching. Eligible subjects will be recruited from Child, Youth and Family services at the Centre for Addiction and Mental Health. The Principal Investigator aims to recruit 12 participants.
Outcomes: Feasibility outcomes are of the primary interest; namely, recruitment rates, proportion of psychiatry appointments attended, proportion of self-report measures completed, proportion of online CBT videos viewed, number of text-exchanges between youth and health coaches, physical activity levels and qualitative feedback from youth about their experiences. Primary clinical outcomes will be described via self-reported depressive symptoms using the Mood and Feelings Questionnaire. Secondary outcomes include self-reported anxiety (anxiety-related subscales of the Revised Children's Anxiety and Depression Scale) and function (Youth Columbia Impairment Scale). The Principal Investigator will also measure self-injurious thoughts and behaviours using the Columbia Suicide Severity Rating Scale.
Discussion: If results confirm hypotheses that youth can be feasibly treated with a remote electronically delivered ICP, further efficacy testing may be performed to assess this as a viable option for service delivery that reduces barriers to care.
- Conditions
- Major Depressive Disorder
- Being tested
- eCARIBOU
- Keywords
- Tele-psychiatry, Adolescent, Depression, Measurement Based Care, Cognitive Behaviour Therapy, e-mental health
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eCARIBOUOther
A 16 week remote electronically deliver Integrated Care Pathway (ICP) for adolescents (13-18 years old) with Major Depressive Disorder (MDD).
| Study group | Role | What they receive |
|---|---|---|
| Remote Electronically Delivered Integrated Care Pathway (ICP) | Experimental | The remote electronically-delivered ICP (also known as eCARIBOU) will consist of psychiatry appointments through telemedicine every 4 weeks over 16 weeks, where the youth is at home. Prior to these appointments, measures (i.e., Mood and Feelings Questionnaire - MFQ) will be sent to the youth to be completed. Change in measure scores will be reviewed collaboratively between the psychiatrist and the youth to assist in making treatment decisions. The medication algorithm in the in-person ICP will be used to guide these decisions. The psychiatrist will also administer the Columbia Suicide Severity Rating Scale (C-SSRS) at each telepsychiatry appointment to monitor risk. Concurrently, youth will be offered internet-based Cognitive Behavioural Therapy (iCBT) and health-coaching via text. Receives: Other: eCARIBOU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Time it takes to recruit 12 participants to the study
Measured: 6 months
Number of Psychiatry Appointments
Proportion of scheduled psychiatry appointments attended (number attended divided by 4 for each participant)
Measured: 16 weeks
Number of iCBT Content Viewed
Proportion of online CBT videos viewed per participant (number viewed divided by 54)
Measured: 16 weeks
Number of Health Coach Text Messages
Number of text messages the participant sent to the health coach (count data)
Measured: 16 weeks
Fitbit Usage
Number of days the fitbit is worn and the percentage of data collected
Measured: 16 weeks
Psychiatric Management
Number of events involving of self-harm behaviour/suicidal ideation that required acute psychiatric management (where the study psychiatrist needs to communicate with the youth and/or family members outside of regular appointments every 4 weeks).
Measured: 16 weeks
Youth's Experience with eCARIBOU
Qualitative Interview feedback from youth pertaining to the intervention - including ease of use, content relevance, level of engagement with the intervention
Measured: 16 weeks
ICP Deviations
Frequency of deviations from the pathway and any documented reasons for deviations
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start4 Jan 2023
- Primary completion23 Jan 2024
- Study completion23 Jan 2024
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Adolescents (age 13-18) with major depressive disorder.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- York University
- Responsible party
- Principal investigator, Darren Courtney, Centre for Addiction and Mental Health
- Investigators
- Darren Courtney, MD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086120
- Sponsor's protocol ID
- 121/2019-01
- Acronym
- eCARIBOU
- Status last verified
- Mar 2024
- First submitted
- 8 Oct 2021
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ritvo P, Knyahnytska Y, Pirbaglou M, Wang W, Tomlinson G, Zhao H, Linklater R, Bai S, Kirk M, Katz J, Harber L, Daskalakis Z. Online Mindfulness-Based Cognitive Behavioral Therapy Intervention for Youth With Major Depressive Disorders: Randomized Controlled Trial. J Med Internet Res. 2021 Mar 10;23(3):e24380. doi: 10.2196/24380.
PubMed 33688840
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Remote Electronically Delivered Integrated Care Pathway for Adolescents With Major Depressive Disorder: A Feasibility Study
- ClinicalTrials.gov ID
- NCT05086120
- Acronym / sponsor ID
- eCARIBOU / 121/2019-01
- Conditions
- Major Depressive Disorder
- Keywords
- Tele-psychiatry, Adolescent, Depression, Measurement Based Care, Cognitive Behaviour Therapy, e-mental health
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- York University
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 23 Jan 2024 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 20 Oct 2021 (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 is a one-armed observational study and feasibility trial of a remote electronically-delivered integrated care pathway for the treatment of adolescents. Eligible participants are between the ages of 13 and 18, inclusive, who have a primary diagnosis of major depressive disorder. Outcomes of interest are recruitment rates and participation in pathway components, including: appointments, measure-completion and use of electronically-delivered cognitive behavioural therapy.
Detailed description
Introduction: Depression is common and debilitating in the adolescent age range. Geography or other logistical barriers may prevent youth from accessing care. Progress in the treatment of youth that uses their tendencies to engage in electronically mediated contacts (e.g., text, online videos, and livestream video chat) can strategically address depressive disorders to overcome these barriers.
Methods: The Principal Investigator will conduct a pilot single-arm trial to assess the feasibility of a 16-week remote electronically delivered integrated care pathway (ICP) for the treatment of adolescents (age 13-18) with major depressive disorder. CBT components being delivered has been tested in the age 18-30 with depression. The ICP includes: tele-psychiatry appointments, online measurement-based care, internet-based cognitive behavioural therapy combined with mindfulness training, and text-based health coaching. Eligible subjects will be recruited from Child, Youth and Family services at the Centre for Addiction and Mental Health. The Principal Investigator aims to recruit 12 participants.
Outcomes: Feasibility outcomes are of the primary interest; namely, recruitment rates, proportion of psychiatry appointments attended, proportion of self-report measures completed, proportion of online CBT videos viewed, number of text-exchanges between youth and health coaches, physical activity levels and qualitative feedback from youth about their experiences. Primary clinical outcomes will be described via self-reported depressive symptoms using the Mood and Feelings Questionnaire. Secondary outcomes include self-reported anxiety (anxiety-related subscales of the Revised Children's Anxiety and Depression Scale) and function (Youth Columbia Impairment Scale). The Principal Investigator will also measure self-injurious thoughts and behaviours using the Columbia Suicide Severity Rating Scale.
Discussion: If results confirm hypotheses that youth can be feasibly treated with a remote electronically delivered ICP, further efficacy testing may be performed to assess this as a viable option for service delivery that reduces barriers to care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Adolescents (age 13-18) with major depressive disorder.
| Arm | Type | Receives |
|---|---|---|
| Remote Electronically Delivered Integrated Care Pathway (ICP) | Experimental | Other: eCARIBOUThe remote electronically-delivered ICP (also known as eCARIBOU) will consist of psychiatry appointments through telemedicine every 4 weeks over 16 weeks, where the youth is at home. Prior to these appointments, measures (i.e., Mood and Feelings Questionnaire - MFQ) will be sent to the youth to be completed. Change in measure scores will be reviewed collaboratively between the psychiatrist and the youth to assist in making treatment decisions. The medication algorithm in the in-person ICP will be used to guide these decisions. The psychiatrist will also administer the Columbia Suicide Severity Rating Scale (C-SSRS) at each telepsychiatry appointment to monitor risk. Concurrently, youth will be offered internet-based Cognitive Behavioural Therapy (iCBT) and health-coaching via text. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 13-18 years old at baseline
- Mood and Feelings Questionnaire - Childhood, long version (MFQ) score of ≥22
- Diagnosis of Major Depressive Disorder by impression from the referring psychiatrist and confirmed using the KSADS
- Internet access at home
- Access to a smartphone for personal and private use, with an associated standard data plan (ie. greater than or equal to 500 MB/month)
Key exclusion criteria (5 listed)
- Individuals that arecurrently receiving structured psychotherapy
- Clinically significant suicidal ideation that is defined as 'imminent intent' or attempted suicide in the past 6 months
- Co-morbid diagnosis of borderline personality disorder (as assessed by the Childhood Interview for Borderline Personality Disorder) (Zanarini, 2003), schizophrenia, bipolar disorder, moderate-to-severe eating disorder, obsessive compulsive disorder and/or severe alcohol/substance use disorder in the past 3 months
- Youth with known or clinically suspected intellectual disability or autism spectrum disorder
- Youth who are not able to provide informed consent for any other reason
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 |
|---|---|---|
| eCARIBOUA 16 week remote electronically deliver Integrated Care Pathway (ICP) for adolescents (13-18 years old) with Major Depressive Disorder (MDD). | Other | Remote Electronically Delivered Integrated Care Pathway (ICP) |
Primary outcome
Recruitment
Time frame: 6 months
Time it takes to recruit 12 participants to the study
Number of Psychiatry Appointments
Time frame: 16 weeks
Proportion of scheduled psychiatry appointments attended (number attended divided by 4 for each participant)
Number of iCBT Content Viewed
Time frame: 16 weeks
Proportion of online CBT videos viewed per participant (number viewed divided by 54)
Number of Health Coach Text Messages
Time frame: 16 weeks
Number of text messages the participant sent to the health coach (count data)
Fitbit Usage
Time frame: 16 weeks
Number of days the fitbit is worn and the percentage of data collected
Psychiatric Management
Time frame: 16 weeks
Number of events involving of self-harm behaviour/suicidal ideation that required acute psychiatric management (where the study psychiatrist needs to communicate with the youth and/or family members outside of regular appointments every 4 weeks).
Youth's Experience with eCARIBOU
Time frame: 16 weeks
Qualitative Interview feedback from youth pertaining to the intervention - including ease of use, content relevance, level of engagement with the intervention
ICP Deviations
Time frame: 16 weeks
Frequency of deviations from the pathway and any documented reasons for deviations
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Background: PubMed 33688840Ritvo P, Knyahnytska Y, Pirbaglou M, Wang W, Tomlinson G, Zhao H, Linklater R, Bai S, Kirk M, Katz J, Harber L, Daskalakis Z. Online Mindfulness-Based Cognitive Behavioral Therapy Intervention for Youth With Major Depressive Disorders: Randomized Controlled Trial. J Med Internet Res. 2021 Mar 10;23(3):e24380. doi: 10.2196/24380.
- Individual participant dataSharing planned: No
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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.
Darren Courtney, MD principal investigator
Centre for Addiction and Mental Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eCARIBOU in people with Major Depressive Disorder, run by Centre for Addiction and Mental Health at 2 sites 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Low enrollment). Results are not available in the source record.
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?
Recruitment (time frame: 6 months). The study lists 8 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 NCT05086120, which also lists 1 linked publication.
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 6 Mar 2024.