PsychosisTECC-YNCT03610087
Technology-Enabled Collaborative Care for Youth
A study testing Low Intensity Intervention and High Intensity Intervention in people with Psychosis and Metabolic Disease, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The overall objective is to develop scalable interventions to address the physical health needs of patients affected by early psychosis. The objective of this project is to conduct a feasibility study of a high intensity technology-enabled collaborative care model (CCM) compared to lower intensity self-help modules… Read more about this study
- Who is it for?
- Ages 16 to 29 years
- Conditions the study is for
- Psychosis, Metabolic Disease, Cardiovascular Risk Factor
- What is being tested?
- Low Intensity Intervention and High Intensity Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jul 2018to 30 Jun 2020
- 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 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ages 16 - 29 years
- Clinician diagnosis of early psychosis (diagnosed in last 5 years)
- Prescribed psychiatric medication, stable for 4 weeks
- Access to telephone or internet through computer or mobile
Who cannot join
- Unable to provide consent
- Unable to understand English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technology-Enabled Collaborative Care for Youth (TECC-Y): A Feasibility Study
The overall objective is to develop scalable interventions to address the physical health needs of patients affected by early psychosis. The objective of this project is to conduct a feasibility study of a high intensity technology-enabled collaborative care model (CCM) compared to lower intensity self-help modules and email support for early identification and treatment of cardio-metabolic risk factors in youth, ages 16-29, affected by early psychosis.
- Conditions
- Psychosis, Metabolic Disease, Cardiovascular Risk Factor
- Being tested
- Low Intensity Intervention, High Intensity Intervention
- Medical subject headings
- Psychotic Disorders, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Intensity InterventionBehavioural
Participants will have access via the online platform to the NAVIGATE self-help modules for physical activity, nutrition and quitting smoking with a list of community resources. Subjects will be sent a standard reminder emails once per week to complete their modules and connect with their main provider for any assistance.
High Intensity InterventionBehavioural
Also called TECC-Y
Participants will receive individualized treatment planning, in collaboration with a Care Coordinator, and the Virtual Care Team (VCT). Interactive modules on physical activity, nutrition and quitting smoking will be provided via the online platform. the virtual team will be engaged to provide treatment and/or recommendations regarding the following: increasing physical activity, improving nutrition and diet, smoking cessation (psychosocial support plus medications), and medication adherence. Participants in this arm will have weekly check-ins with their assigned Care Coordinator where they will be able to discuss VCT recommendations, and progress on their goals.
| Study group | Role | What they receive |
|---|---|---|
| Low Intensity Intervention | Other | The comparison group (low intensity) receives access to the e-platform and given an educational package with information about nutrition, physical activity, and smoking based on the NAVIGATE program (Mueser et al., 2015); i.e., a comprehensive program for implementing coordinated speciality care) with weekly e-mail reminders for 12 weeks. Participants receive access to online resources and free online webinars about these healthy behaviours. Receives: Behavioral: Low Intensity Intervention |
| High Intensity Intervention | Experimental | The intervention group (high intensity) receives a technology-enabled CCM intervention. Participants receive access to an online platform and infographic modules to learn more about nutrition, physical activity, and smoking cessation. Also, they are assigned a personal health coach who collaboratively schedules weekly virtual sessions via the platform to discuss the educational materials, goal setting and motivation, and provide support in the 12-week program. The participant's health coach reviews the participant's concerns and goals weekly with a virtual care team (VCT; including a psychiatrist, addictions specialist, nutrition specialist, peer mentor, and recreational therapist), who provides individualized recommendations to include in the participant's treatment plan. Participants have access to online resources and online webinars about nutrition, physical activity and smoking. Receives: Behavioral: High Intensity Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient engagement
The primary outcome is patient engagement will be defined as participant activation in the program measured via self-report levels of perceived benefit from the program.
Measured: Baseline, 6-weeks, 12-weeks, and 24-weeks.
Secondary outcomes (1)
Healthy Behaviour Change
The secondary outcome is to explore whether a CCM will help facilitate healthy behavioral changes in physical activity, nutrition, and smoking.
Measured: Baseline, 6-weeks, 12-weeks, and 24-weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start25 Jul 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
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 PsychosisStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Psychiatry Alliance, Trillium Health Centre, The Hospital for Sick Children, University of Toronto
- Responsible party
- Principal investigator, Peter Selby, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610087
- Sponsor's protocol ID
- 121-2017
- Acronym
- TECC-Y
- Status last verified
- Jul 2020
- First submitted
- 16 Jul 2018
- Last updated
- 15 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Selby P, Vojtila L, Ashfaq I, Dragonetti R, Melamed OC, Carriere R, LaChance L, Kohut SA, Hahn M, Mulsant BH. Technology-enabled collaborative care for youth with early psychosis: A protocol for a feasibility study to improve physical health behaviours. Early Interv Psychiatry. 2021 Aug;15(4):828-836. doi: 10.1111/eip.13018. Epub 2020 Aug 3.
PubMed 32748501
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-Enabled Collaborative Care for Youth (TECC-Y): A Feasibility Study
- ClinicalTrials.gov ID
- NCT03610087
- Acronym / sponsor ID
- TECC-Y / 121-2017
- Conditions
- Psychosis, Metabolic Disease, Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Medical Psychiatry Alliance, Trillium Health Centre, The Hospital for Sick Children, University of Toronto
- Study start
- 25 Jul 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 1 Aug 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.
The overall objective is to develop scalable interventions to address the physical health needs of patients affected by early psychosis. The objective of this project is to conduct a feasibility study of a high intensity technology-enabled collaborative care model (CCM) compared to lower intensity self-help modules and email support for early identification and treatment of cardio-metabolic risk factors in youth, ages 16-29, affected by early psychosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Intensity Intervention | Other | Behavioral: Low Intensity InterventionThe comparison group (low intensity) receives access to the e-platform and given an educational package with information about nutrition, physical activity, and smoking based on the NAVIGATE program (Mueser et al., 2015); i.e., a comprehensive program for implementing coordinated speciality care) with weekly e-mail reminders for 12 weeks. Participants receive access to online resources and free online webinars about these healthy behaviours. |
| High Intensity Intervention | Experimental | Behavioral: High Intensity InterventionThe intervention group (high intensity) receives a technology-enabled CCM intervention. Participants receive access to an online platform and infographic modules to learn more about nutrition, physical activity, and smoking cessation. Also, they are assigned a personal health coach who collaboratively schedules weekly virtual sessions via the platform to discuss the educational materials, goal setting and motivation, and provide support in the 12-week program. The participant's health coach reviews the participant's concerns and goals weekly with a virtual care team (VCT; including a psychiatrist, addictions specialist, nutrition specialist, peer mentor, and recreational therapist), who provides individualized recommendations to include in the participant's treatment plan. Participants have access to online resources and online webinars about nutrition, physical activity and smoking. |
Who may qualify
- Ages
- 16 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Ages 16 - 29 years
- Clinician diagnosis of early psychosis (diagnosed in last 5 years)
- Prescribed psychiatric medication, stable for 4 weeks
- Access to telephone or internet through computer or mobile
Key exclusion criteria (2 listed)
- Unable to provide consent
- Unable to understand English
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 |
|---|---|---|
| Low Intensity InterventionParticipants will have access via the online platform to the NAVIGATE self-help modules for physical activity, nutrition and quitting smoking with a list of community resources. Subjects will be sent a standard reminder emails once per week to complete their modules and connect with their main provider for any assistance. | Behavioural | Low Intensity Intervention |
| High Intensity InterventionAlso: TECC-YParticipants will receive individualized treatment planning, in collaboration with a Care Coordinator, and the Virtual Care Team (VCT). Interactive modules on physical activity, nutrition and quitting smoking will be provided via the online platform. the virtual team will be engaged to provide treatment and/or recommendations regarding the following: increasing physical activity, improving nutrition and diet, smoking cessation (psychosocial support plus medications), and medication adherence. Participants in this arm will have weekly check-ins with their assigned Care Coordinator where they will be able to discuss VCT recommendations, and progress on their goals. | Behavioural | High Intensity Intervention |
Primary outcome
Change in patient engagement
Time frame: Baseline, 6-weeks, 12-weeks, and 24-weeks.
The primary outcome is patient engagement will be defined as participant activation in the program measured via self-report levels of perceived benefit from the program.
1 secondary outcome
Healthy Behaviour Change
Time frame: Baseline, 6-weeks, 12-weeks, and 24-weeks.
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 15 Jul 2020.
- Derived from this study: PubMed 32748501Selby P, Vojtila L, Ashfaq I, Dragonetti R, Melamed OC, Carriere R, LaChance L, Kohut SA, Hahn M, Mulsant BH. Technology-enabled collaborative care for youth with early psychosis: A protocol for a feasibility study to improve physical health behaviours. Early Interv Psychiatry. 2021 Aug;15(4):828-836. doi: 10.1111/eip.13018. Epub 2020 Aug 3.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Intensity Intervention and High Intensity Intervention in people with Psychosis and Metabolic Disease, run by Centre for Addiction and Mental Health 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 2 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 15 Jul 2020. 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?
Change in patient engagement (time frame: Baseline, 6-weeks, 12-weeks, and 24-weeks.). 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 NCT03610087, 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 15 Jul 2020.