Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Schizophrenia
  • Bipolar Disorder
  • Depressive Psychosis
  • First Episode Psychosis
  • Psychoses, Affective
  • Psychosis
  • Psychotic Episode
  • Schizoaffective Disorder
  • Schizophrenia Spectrum and Other Psychotic Disorders
  • Schizophreniform Disorders
  • Substance Induced Psychoses
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Immediately after study enrollment, participants will be randomized using an electronic data management system to the active or sham intervention. Randomization will be stratified by sex and referral source (main emergency department vs. Bridging Clinic), using a computer algorithm to perform a blocked randomization assignment within strata.Masking: Double (Investigator, Outcomes Assessor)Masking Description: Participants will not be notified of treatment assignment, but based on the nature of the intervention, they cannot be fully masked. Their care provider may know treatment assignment if disclosed by the participant, or if they get notified that the participant is in distress. Treatment assignment will be known by the research personnel involved in managing the intervention and the database linking participant information to study identification numbers. Treatment assignment may be known by a co-principal investigator providing clinical supervision for adverse or serious events. Research personnel involved in qualitative interviews will also be aware of treatment assignment since only individuals receiving the active treatment participate. The lead principal investigator and research personnel involved in the chart review (where the primary outcome will be extracted) and other analyses will be masked to treatment assignment.Primary Purpose: Health Services Research

Participation Requirements

Age
Between 16 years and 29 years
Gender
Both males and females

Description

At the Centre for Addiction and Mental Health (CAMH), the investigators will recruit a consecutive series of 186 participants aged 16 to 29 referred by the CAMH ED to CAMH's EPI program for a pragmatic randomized controlled trial of a 2-way SMS intervention involving reminders, psychoeducation, and ...

At the Centre for Addiction and Mental Health (CAMH), the investigators will recruit a consecutive series of 186 participants aged 16 to 29 referred by the CAMH ED to CAMH's EPI program for a pragmatic randomized controlled trial of a 2-way SMS intervention involving reminders, psychoeducation, and check-ins. The primary outcome will be rate of attendance at the first consultation appointment assessed through chart reviews. Secondary outcomes will include indicators of long-term service engagement as well as symptoms and functioning 6 months following study enrollment and health service utilization for up to 2 years using administrative data from the Institute for Clinical Evaluative Sciences (ICES). Administrative data will be used for an economic analysis. Participants who receive the active intervention will be asked to complete a web-based survey evaluating their experience and a subgroup will be asked to participate in in-depth in-person qualitative interviews. Patients and family members with lived experience will be engaged in all aspects of the project, including shaping the intervention and study design. The investigators hypothesize that the intervention will result in increased rate of attendance at the first EPI consultation appointment, as well as improved longer-term engagement in outpatient EPI services compared to the sham comparator. Demonstrating evidence that this low-cost, low-complexity, youth-friendly intervention improves engagement in outpatient EPI services has the potential to improve long-term outcomes for young people with psychosis.

Tracking Information

NCT #
NCT04298450
Collaborators
  • Canadian Institutes of Health Research (CIHR)
  • Institute for Clinical Evaluative Sciences
Investigators
Principal Investigator: Nicole Kozloff, MD, SM Centre for Addiction and Mental Health Principal Investigator: George Foussias, MD, PhD Centre for Addiction and Mental Health Principal Investigator: Aristotle N Voineskos, MD, PhD Centre for Addiction and Mental Health Principal Investigator: Vicky Stergiopoulos, MD, MHSc Centre for Addiction and Mental Health Principal Investigator: Albert HC Wong, MD, PhD Centre for Addiction and Mental Health
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