NCT04298450

Brief Summary

Psychosis is a disabling condition that typically has its onset in adolescence and early adulthood. Many young people with psychosis have difficulty navigating services or are reluctant to engage in treatment until their illness becomes an emergency. Consequently, nearly half of all new psychotic disorders are diagnosed in the emergency department (ED). Despite the rationale and evidence for early psychosis intervention (EPI), around half of youth do not access these services. The investigators will use short message service (SMS)/text messaging, a low-cost, low-complexity, youth-friendly approach, to improve transitions in care from the ED and related acute services to EPI services, investigating the intervention's effect on attendance at the first consultation appointment, longer term service engagement, and system-level outcomes. The investigators will also evaluate cost-effectiveness and user perspectives of the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 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

March 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

September 21, 2020

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

March 18, 2026

Status Verified

August 1, 2025

Enrollment Period

4.7 years

First QC Date

March 3, 2020

Last Update Submit

March 16, 2026

Conditions

Keywords

Early Psychosis InterventionMobile Health InterventionPatient and Family EngagementPragmatic Clinical TrialsTransitions in Care

Outcome Measures

Primary Outcomes (1)

  • Attendance at the first early psychosis intervention (EPI) consultation appointment

    Attendance at the outpatient EPI consultation appointment will be assessed through chart reviews and categorized as: Yes - attended at original appointment time, Yes - attended at later date within 30 days, No - did not attend appointment within 30 days.

    30 days

Secondary Outcomes (11)

  • Service engagement - absolute drop-out

    6 months

  • Service engagement - Service Engagement Scale (SES)

    6 months

  • Change in psychotic illness as measured by the Clinical Global Impression (CGI)

    6 months

  • System-level outcomes: emergency department visits

    6 months and 2 years

  • System-level outcomes: mental health hospitalizations

    6 months and 2 years

  • +6 more secondary outcomes

Study Arms (2)

Active SMS Intervention

EXPERIMENTAL

Participants assigned to the experimental arm will receive the active SMS intervention. Participants in the active intervention group who consent to participate will be asked to complete a web-based survey. Based on survey findings, purposive sampling will be used to select a subsample of 12 to 20 participants for qualitative interviews.

Behavioral: Active SMS Intervention

Sham SMS

SHAM COMPARATOR

Participants assigned to the sham comparator will receive the sham SMS intervention. They will not be re-contacted.

Behavioral: Sham SMS

Interventions

Welcome message letting participant know they will be contacted to book an appointment, followed by appointment reminders and other clinic information, psychoeducational materials, and a distress check-in with two-way feedback to their care team, all sent by SMS/text message at the participant's preferred time of day. If they indicate that they are in high distress, or they request, their care provider will be notified and asked to reach out to them. They will also receive crisis resources.The intervention will continue until the patient attends the first consultation appointment, or for up to 30 days if the patient does not attend, which reflects the program's practice of closing referrals for non-attending patients.

Active SMS Intervention
Sham SMSBEHAVIORAL

Single welcome message letting participant know they will be contacted to book an appointment.

Sham SMS

Eligibility Criteria

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

You may qualify if:

  • Have been referred by the Centre for Addiction and Mental Health (CAMH) emergency department or related acute services to the CAMH early psychosis intervention (EPI) program for suspected psychosis

You may not qualify if:

  • Inability to communicate in basic written English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J1H1, Canada

Location

Related Publications (1)

  • Polillo A, Foussias G, Wong AHC, Ampofo A, Stergiopoulos V, Anderson KK, Bromley S, D'Arcey J, de Oliveira C, Duda L, Henderson J, Kidd S, Kurdyak P, Wang W, Zaheer J, Voineskos AN, Kozloff N. ED to EPI: protocol for a pragmatic randomised controlled trial of an SMS (text) messaging intervention to improve the transition from the emergency department to early psychosis intervention for young people with psychosis. BMJ Open. 2020 Dec 17;10(12):e042751. doi: 10.1136/bmjopen-2020-042751.

MeSH Terms

Conditions

Psychotic DisordersAffective Disorders, PsychoticBipolar DisorderSchizophreniaSchizophrenia Spectrum and Other Psychotic DisordersPsychoses, Substance-Induced

Condition Hierarchy (Ancestors)

Mental DisordersBipolar and Related DisordersMood DisordersPoisoningChemically-Induced DisordersSubstance-Related Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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 vs. inpatient unit), using a computer algorithm to perform a blocked randomization assignment within strata.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 6, 2020

Study Start

September 21, 2020

Primary Completion

June 20, 2025

Study Completion

December 20, 2025

Last Updated

March 18, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

De-identified individual patient data (IPD) other than system-level data held at ICES will be available upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Within 12 months of posting the study results on this website
Access Criteria
Access is provided after a research proposal is submitted and has received approval from the study's Steering Committee and after Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations