Using Short Message Service as a Means of Clinical Engagement in Early Psychosis

May 6, 2020 updated by: George Foussias, Centre for Addiction and Mental Health
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5T 1R8
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 29 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active SMS
Weekly interactive SMS text messaging check-ins.
Interactive SMS text message check-ins delivered once weekly to participants.
Sham Comparator: Sham SMS
Weekly minimally interactive SMS text messages.
Minimally interactive SMS text message delivered once weekly to participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Service Engagement Scale (SES)
Time Frame: 9 months
Clinician-rated treatment engagement and adherence (minimum score = 0, maximum score = 42, higher score indicates worse service engagement)
9 months
Appointment Attendance
Time Frame: 9 months
Percentage of attended clinic appointments
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergency Department Visits
Time Frame: 9 months
Number of emergency department visits
9 months
Hospitalizations
Time Frame: 9 months
Number of hospitalizations
9 months
Social Functioning Scale (SFS)
Time Frame: 9 months
Self-report measure of social functioning (minimum score = 0, maximum score = 247, higher score indicates better functioning)
9 months
Personal and Social Performance Scale (PSP)
Time Frame: 9 months
Interview-rated measure of global functioning (minimum score = 1, maximum score = 100, higher score indicates better functioning)
9 months
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LESQ-18)
Time Frame: 9 months
Self-reported measure of subjective quality of life (minimum score = 1, maximum score = 5, higher score indicates better quality of life)
9 months
Clinical Global Impression (CGI)
Time Frame: 9 months
Interview-based global rating of illness severity (minimum score = 1, maximum score = 7, higher score indicates worse illness severity)
9 months
Brief Psychiatric Rating Scale (BPRS)
Time Frame: 9 months
Interview-based measure of the severity of psychiatric symptoms (minimum score = 24, maximum score = 168, higher score indicates higher severity of symptoms)
9 months
Scale for the Assessment of Negative Symptoms (SANS)
Time Frame: 9 months
Interview-based measure of the severity of negative symptoms (minimum score = 0, maximum score = 110, higher score indicates higher severity of symptoms)
9 months
Apathy Evaluation Scale (AES)
Time Frame: 9 months
Interview-rated measure of the severity of motivation deficits (minimum score = 18, maximum score = 72, higher score indicates worse motivation deficits)
9 months
Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)
Time Frame: 9 months
Rater-administered measure of cognitive functioning (scores indicate standardized Z-scores with no pre-defined minimum or maximum score, higher score indicates better cognitive functioning)
9 months
Drug Attitude Inventory (DAI-10)
Time Frame: 9 months
Self-reported measure of medication adherence (minimum score = -10, maximum score = + 10, higher score indicates better adherence)
9 months
Scale To Assess Therapeutic Relationships - Patient Version (STAR-P)
Time Frame: 9 months
Self-reported measure of the clinician-patient therapeutic relationship (minimum score = 0, maximum score = 48, higher score indicates better therapeutic relationship)
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: George Foussias, MD PhD, Centre for Addiction and Mental Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

May 5, 2020

First Submitted That Met QC Criteria

May 5, 2020

First Posted (Actual)

May 7, 2020

Study Record Updates

Last Update Posted (Actual)

May 8, 2020

Last Update Submitted That Met QC Criteria

May 6, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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