NCT04379349

Brief Summary

Engagement with clinical services for youth with early psychosis represents a significant challenge, with up to 40% of patients dropping out of treatment in the first year. This has been linked to worse illness outcomes and represents a significant barrier to recovery for these patients. This study aims to evaluate the efficacy of short message service (SMS) as a means of improving clinical engagement in early-episode psychosis populations by bridging contact between appointments with weekly check-ins/reminders. These weekly check-ins during the first year of treatment will serve as an additional opportunity to reach out to patients and give them a chance to do the same with their care teams, with patient responses triggering clinician follow-up if necessary.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 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

Study Start

First participant enrolled

January 1, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

2.2 years

First QC Date

May 5, 2020

Last Update Submit

May 6, 2020

Conditions

Psychotic Disorders

Keywords

SMS text messagingClinical engagement

Outcome Measures

Primary Outcomes (2)

  • Service Engagement Scale (SES)

    Clinician-rated treatment engagement and adherence (minimum score = 0, maximum score = 42, higher score indicates worse service engagement)

    9 months

  • Appointment Attendance

    Percentage of attended clinic appointments

    9 months

Secondary Outcomes (12)

  • Emergency Department Visits

    9 months

  • Hospitalizations

    9 months

  • Social Functioning Scale (SFS)

    9 months

  • Personal and Social Performance Scale (PSP)

    9 months

  • Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LESQ-18)

    9 months

  • +7 more secondary outcomes

Study Arms (2)

Active SMS

EXPERIMENTAL

Weekly interactive SMS text messaging check-ins.

Behavioral: SMS text messaging - interactive check-in

Sham SMS

SHAM COMPARATOR

Weekly minimally interactive SMS text messages.

Behavioral: SMS text messaging - inactive control

Interventions

SMS text messaging - interactive check-inBEHAVIORAL

Interactive SMS text message check-ins delivered once weekly to participants.

Active SMS
SMS text messaging - inactive controlBEHAVIORAL

Minimally interactive SMS text message delivered once weekly to participants.

Sham SMS

Eligibility Criteria

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

You may qualify if:

  • between the ages of 16-29
  • a diagnosis of an affective or non-affective psychotic disorder (i.e., Bipolar or Major Depressive Disorders with Psychotic Features, Schizophrenia Spectrum Disorders, Other Specified Psychotic Disorders, Substance Induced Psychosis and Attenuated Psychotic Syndrome)
  • eligible for follow-up within the Slaight Family Centre for Youth in Transition early intervention service
  • within the first 6 months of treatment

You may not qualify if:

  • involved in another intervention study
  • do not have a personal cell phone number

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Publications (1)

  • D'Arcey JN, Zhao H, Wang W, Voineskos AN, Kozloff N, Kidd SA, Foussias G. An SMS text messaging intervention to improve clinical engagement in early psychosis: A pilot randomized-controlled trial. Schizophr Res. 2024 Feb;264:416-423. doi: 10.1016/j.schres.2024.01.012. Epub 2024 Jan 18.

    PMID: 38241785DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • George Foussias, MD PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician Scientist

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 7, 2020

Study Start

January 1, 2018

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

May 8, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)