A New Paradigm for Illness Monitoring and Relapse Prevention in Schizophrenia
Phase: NA
Conditions: Schizophrenia, Schizoaffective Disorder
Sponsor: Dartmouth-Hitchcock Medical Center

A New Paradigm for Illness Monitoring and Relapse Prevention in Schizophrenia 
NCT number: NCT01952041 
Date: 8/26/2018 

Overview of the Study  
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.  
One-hundred and fifty one participants were recruited for the 12 months of system deployment. 
Participants who continued to randomization were randomized to a smartphone arm (n=62) or an 
arm with treatment as usual (TAU) (n=66). Randomization was conducted by a blinded study 
statistician. Participants in the smartphone arm met with a researcher to discuss previous relapse 
incidents and develop a personalized plan for action for when the system flagged relapse risk. A 
blinded clinical assessor conducted assessments with all participants at baseline and every 3 
months post-randomization to assess in-person symptom severity (Brief Psychiatric Rating Scale 
- BPRS), depression (Calgary Depression Scale for Schizophrenia - CDSS), and social 
functioning (Social Functioning Scale - SFS). Information from Electronic Medical Records (i.e., 
hospitalization, ER visits, arrests, medication changes) was also culled every 3 months. 
Recruitment  
 
Eligible individuals at a medical clinic were identified through electronic medical records and 
approached by a staff member to be recruited for the study. Recruitment was open from March 
2015 until July 2016. 
 
Inclusion/Exclusion Criteria  
 
Inclusion criteria: 1) 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, 2) 18 years or older; 3) an inpatient psychiatric hospitalization, daytime 
psychiatric hospitalization, outpatient crisis management, or short-term psychiatric hospital 
emergency room within 12 months before study entry; and 4) willing and able to provide 
informed consent.  
 
Exclusion criteria: 1) Hearing, vision, or motor impairment that make it impossible to operate a 
smartphone (determined using a demonstration smartphone for screening); and 2) 6th grade 
reading level (determined by Wide Range Achievement Test - 4th Edition). 
 
Instruments  
 
1. Wide Range Achievement Test Ed. 4 is a brief screening test in which participants read a 
list of 55 words and receive a grade equivalent rating. Administered only at initial 
eligibility screening for participation.  
2. Participant Demographics. Participants reported age, race, ethnicity, gender, education, 
history of mobile phone use, etc. to research staff at baseline. 

3. Brief Psychiatric Rating Scale (BPRS) is an 18-item scale that rates severity of positive 
symptoms (including auditory hallucinations and persecutory ideation), and mood and 
behavioral symptoms. Items were rated by a clinical assessor on a scale of 1 (absent) to 7 
(very severe), and yield three scaled scores: positive symptoms, negative symptoms, and 
general psychopathology. Higher scores indicate worse symptoms. Administered at 
baseline and every three months. 
4. Social Functioning Scale (SFS) 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). A higher score indicates greater 
social functioning. Administered at baseline and every three months. 
5. Calgary Depression Scale for Schizophrenia (CDSS) 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. A higher score indicates more 
severe symptoms. Administered at baseline and every three months. 
 
Participant Remuneration  
Participants enrolled in the RCT were compensated $20 for each assessment, but not 
compensated for actual use of the application. Participants in the smartphone arm were given the 
smartphone at the end of the study.  
Statistical Analysis  
 
Primary outcomes were relapses in participants (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 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) and time to relapse (total time from study commencement to first relapse). Relapses 
were analyzed using logistic regression, adjusting for potential baseline confounding variables. 
Survival Analysis (Cox Proportional Hazards Models) was used to evaluate time to relapse over 
the 12-month intervention period. Models were refined by including any baseline factors that 
may differ between groups as covariates.  
Secondary outcomes were psychotic symptom severity (BPRS), depression (CDSS), and social 
functioning (SFS), as these are salient antecedents to relapse. A mixed-effects model with 
random intercept and slope was used to test the difference in improvement between the 
intervention group and the TAU group. This approach takes serial correlation across time into 
account and does not drop participants from the analysis who have missing assessments or have 
dropped out. Intervention group (Smartphone vs. TAU), time (coded as 0=baseline, 1=3 months, 
2=6 months, 3=9 months, 4=12 months), and group by time interaction were included in the 
model. Differential improvements were evaluated by the group by time interaction.