- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04379349
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
Status
Completed
Conditions
Intervention / Treatment
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 091-2017
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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