NCT03610087

Brief 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 and email support for early identification and treatment of cardio-metabolic risk factors in youth, ages 16-29, affected by early psychosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

July 25, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

1.9 years

First QC Date

July 16, 2018

Last Update Submit

July 13, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, 6-weeks, 12-weeks, and 24-weeks.

Secondary Outcomes (1)

  • Healthy Behaviour Change

    Baseline, 6-weeks, 12-weeks, and 24-weeks.

Study Arms (2)

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.

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.

Behavioral: High Intensity Intervention

Interventions

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.

Low Intensity Intervention

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.

Also known as: TECC-Y
High Intensity Intervention

Eligibility Criteria

Age16 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Unable to provide consent
  • Unable to understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T1P7, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Psychotic DisordersMetabolic Diseases

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Physician-in-Chief- Education|Clinician Scientist|Chief, Medicine in Psychiatry Division|CAMH|

Study Record Dates

First Submitted

July 16, 2018

First Posted

August 1, 2018

Study Start

July 25, 2018

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

July 15, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations