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

Study Overview
=================
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.

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

Conditions
-----------------
Psychotic Disorders

Intervention / Treatment
-----------------
* Behavioral: SMS text messaging - interactive check-in
* Behavioral: SMS text messaging - inactive control


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 29 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active SMS<br>Weekly interactive SMS text messaging check-ins. | Behavioral: SMS text messaging - interactive check-in<br>* Interactive SMS text message check-ins delivered once weekly to participants.<br>|
| Sham Comparator: Sham SMS<br>Weekly minimally interactive SMS text messages. | Behavioral: SMS text messaging - inactive control<br>* Minimally interactive SMS text message delivered once weekly to participants.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emergency Department Visits | Number of emergency department visits | 9 months | 
| Hospitalizations | Number of hospitalizations | 9 months | 
| Social Functioning Scale (SFS) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | Self-reported measure of the clinician-patient therapeutic relationship (minimum score = 0, maximum score = 48, higher score indicates better therapeutic relationship) | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SMS text messaging, Clinical engagement