A New Paradigm for Illness Monitoring and Relapse Prevention in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This study was a 2-arm randomized control trial (RCT) designed to test a multi-modal smartphone data collection system that provided mobile monitoring of schizophrenia to detect early signs of relapse. The RCT compared an arm with participants who received treatment as usual with an arm that received the smartphone system for a year.

Official Title
-----------------
A New Paradigm for Illness Monitoring and Relapse Prevention in Schizophrenia

Conditions
-----------------
Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
-----------------
* Behavioral: Device: Smartphone
* Behavioral: Treatment as usual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria for schizophrenia, schizoaffective disorder, or psychosis not otherwise specified based on a chart diagnosis 18 years or older An inpatient psychiatric hospitalization, daytime psychiatric hospitalization, outpatient crisis management, or short-term psychiatric hospital emergency room within 12 months before study entry Willing and able to provide informed consent Exclusion Criteria: Hearing, vision, or motor impairment that make it impossible to operate a smartphone (determined using a demonstration smartphone for screening) 6th grade reading level (determined by Wide Range Achievement Test- 4th Edition)

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Device: Smartphone<br>Participants in the smartphone intervention arm received treatment as usual in addition to receiving a smartphone with the study application. The study application identified relapse risk and prompted the clinical team to provide enhanced services. | Behavioral: Device: Smartphone<br> <br> |
| Active Comparator: Treatment as Usual<br>Treatment as usual included outpatient case management, linkage to services and medication monitoring. | Behavioral: Treatment as usual<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapses in Participants | A count of participants who experienced relapse, as defined as one of the following events: psychiatric hospitalization, a significant increase in the level of psychiatric care (i.e. frequency and intensity of services), an increase in medication in addition to a 25% increase in Brief Psychiatric Rating Scale (BPRS) from last assessment, suicidal or homicidal ideation that was clinically significant in the investigator's judgement, deliberate self-injury, violent behavior resulting in damage to another person or property. | 1 year | 
| Time to Relapse | Time to first relapse was defined as the time from randomization until the first relapse. Participants who did not experience a relapse were censored at their last known time relapse-free. Time-to-first relapse was estimated using the Kaplan-Meier method. | From randomization date until first relapse (evaluated approximately every 3 months until their last study visit which occurred approximately 12 months from randomization for those who completed the study). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychotic Symptom Severity | Psychotic symptom severity assessed using the Brief Psychiatric Rating Scale (BPRS). This is an 18-item scale that rates severity of positive symptoms (including auditory hallucinations and persecutory ideation), and mood and behavioral symptoms. Items are rated by a clinical assessor on a scale of 1 (absent) to 7 (very severe). Total scores range from 18-126. Higher scores indicate worse symptoms. | Assessed at baseline and every three months for one year. | 
| Depression | Depression measured using the Calgary Depression Scales (CDSS). This is a 9-item assessment with values of 0 (absent) to 3 (severe) of depressive symptoms separate from positive, negative and extrapyramidal symptoms in people with schizophrenia. Total scores range from 0-27. A higher score indicates more severe symptoms. | Assessed at baseline and every three months for one year. | 
| Social Functioning | Social Functioning was assessed using the Social Functioning Scale (SFS). This is a 76-item questionnaire that assesses various aspects of social functioning and generates a number of subscale scores including social withdrawal, interpersonal behavior, pro-social activities, and an overall score of social functioning. The item values range from 0 (almost never) to 3 (often). Total scores range from 0-228. A higher score indicates greater social functioning. | Assessed at baseline and every three months for one year. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, Schizoaffective Disorder, Mobile Application, Relapse, SMI, EHealth, E-Health, Health Technology, mHealth, m-Health, Mobile Health, Serious Mental Illness, Electronic Health