Development of a Mobile System for Self-management of Schizophrenia (SOS)
Phase: NA
Conditions: Schizophrenia, Schizoaffective Disorder
Sponsor: Dartmouth-Hitchcock Medical Center

 
Development of a Mobile System for Self-management of Schizophrenia (SOS) 
Randomized Controlled Trial: treatment arm (n=26) Vs control arm (n=25) 
 
Overview of the Study  
 
This 2-arm RCT piloted a mobile Self-Management of Schizophrenia (SOS) system. Researchers 
compared an intervention arm using the SOS system and an arm receiving treatment as usual on 
the outcomes of change in severity of psychotic symptoms and change in social functioning.  
 
Overview of the Smartphone Application Intervention and Features  
 
The mobile application tested in this RCT was developed for smartphones. The final smartphone 
application design was largely determined by participant feedback provided in focus groups and 
usability testing.  
 
Recruitment  
 
Individuals with schizophrenia or schizoaffective disorder who were receiving services at the 
primary study site were recruited through flyers in waiting rooms and bulletin boards at 
treatment centers, and through referrals from clinical staff. Enrollment was open from November 
2015 to July 2016.  
 
Inclusion/Exclusion Criteria  
 
Inclusion criteria were: 1) Chart diagnosis of DSM-IV criteria for schizophrenia or 
schizoaffective disorder; 2) 18 years or older; 3) prescribed antipsychotic medication; 4) ability 
(determined by using a competency screener) and willingness to provide informed consent; and 
5) a rating of “3” or lower on one of the three items which comprise the Domination by 
Symptoms factor from the Recovery Assessment Scale, indicating patient-rated need for illness 
self-management. Exclusion criteria were: 1) Hearing, vision, or motor impairment that make it 
impossible to operate a smartphone or respond to prompts (determined using demonstration 
smartphone for screening); and 2) English reading level below 4th grade (determined using the 
Wide Range Achievement Test - 4th Edition).  
 
Randomization and Instruments  
 
Blind clinical raters conducted assessments, and participants were randomized after the baseline 
assessment to receive 12 weeks of a smartphone intervention or treatment as usual (TAU).  
 
1. Writing and Reading Assessment Test Ed. 4 is a brief screening test in which 
participants read a list of 55 words and received a grade equivalent rating. 
Administered only at initial eligibility screening for participation.  
2. Psychotic Symptom Rating Scales (PSYRATS) is comprised of 17 items inquiring 
about the specific dimensions of hallucinations and delusions, with each item being 

rated from 0 (absent) to 4 (severe). The PSYRATS has 2 subscales: the auditory 
hallucinations subscale (AHS) consisting of 11 items, and the delusions subscale (DS) 
consisting of 6 items. The measure has a minimum score of 0 and a maximum score 
of 68, with higher scores indicating worse symptoms. This was administered at 
baseline and at 12 weeks.  
3. Social Functioning Scale (SFS) Social Engagement / Withdrawal and Interpersonal 
Communication Sub-Scales from the SFS were collected to assess social functioning. 
These subscales consist of 15 items total. The item values range from 0 (almost 
never) to 3 (often). A higher score indicates greater social functioning. The SFS was 
developed for outpatients with schizophrenia. This was administered at baseline and 
at 12 weeks.  
4. Beck Depression Inventory (BDI) is a 21-question self-report inventory, assessing 
sleep loss, appetite loss, feelings of being punished, thoughts about suicide, and 
interest in sex for the past two weeks. This was administered at baseline and at 12 
weeks.  
5. Insomnia Severity Index (ISI) is a brief 7-item self-report screening measure of 
insomnia. The scale is a reliable and valid instrument to quantify perceived insomnia 
severity. This was administered at baseline and at 12 weeks.  
6. Beliefs about Medicines Questionnaire (BMQ) is a 18-item self-rated questionnaire 
that uses a 5-point Likert scale to measure patients’ concerns about taking their 
medication and the necessity they feel to take the medication. It also measures more 
general beliefs or social representations about pharmaceuticals as a class of treatment. 
This was administered at baseline and at 12 weeks.  
7. Working Alliance Inventory (WAI) is a 12-item scale with 7-point Likert responses 
that provides an overall measure of alliance between patients and clinical support 
workers.  
8. Schizophrenia Patient Activation Measure (SPAM) is an adaptation of the Patient 
Activation Measure (PAM). This measure is 14 items with 5-point Likert responses. 
It measures confidence in self-management and understanding of the participant’s 
schizophrenia. This was administered at baseline and at 12 weeks.  
9. Participant Demographics Survey Participants reported age, race, ethnicity, gender, 
education, history of mobile phone use etc. to research staff at the baseline interview.  
 
Participant Remuneration  
 
Participants enrolled in the RCT were compensated for participation in the screening interview 
($15) and ($30) for each in-person assessment (baseline/12 weeks). Participants were 
compensated for completion of assessments, not the use of the intervention. The cellular 
data/text message plans that enabled participants to make calls and send text messages were paid 
for with study funds.  
 
Statistical Analysis  
 
We tested the difference in improvement between the intervention group and the TAU (treatment 
as usual) group on two outcomes: psychiatric symptoms and social functioning. A linear mixed 

effects model was used for these analyses. This approach takes correlation across time into 
account and does not drop participants from the analysis who have missing assessments or have  
dropped out. Intervention group (Mobile Application (SOS) vs. TAU), time (coded as 0 = 
baseline, 1 =12 weeks), and the group by time interaction was included in the model. Differential 
improvement between groups was evaluated by the group by time interaction. Due to the small 
sample size of the study, quantity and direction of the treatment effect (i.e., the effect size), 
rather than statistical significance, was emphasized in interpretation.