Mobile After-Care Support App: Pilot RCT

Study Overview
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Brief Summary
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The overall aim of this program of research is to refine and test the feasibility and acceptability of a newly developed mobile device-delivered app, called Mobile After-Care Support (MACS), to improve patients' coping and treatment adherence following a hospitalization related to their psychotic-spectrum disorder. The purpose of the proposed project is to establish the feasibility, acceptability, and preliminary effects of the app. To achieve the specific aims, the investigators will conduct a pilot randomized clinical trial (n = 60), with two treatment arms: MACS vs. a mobile app attention control condition.

Official Title
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Mobile After-Care Support Intervention for Patients With Schizophrenia Following Hospitalization: Pilot RCT

Conditions
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Psychotic Disorder

Intervention / Treatment
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* Behavioral: Mobile After-Care Support (MACS) app
* Behavioral: Mobile app attention control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: recently hospitalized DSM-5 criteria for psychotic-spectrum disorder based on structured clinical interview 18 years or older prescribed antipsychotic medication upon discharge ability to speak and read English Exclusion Criteria: substance use disorders at severe level planned discharge to supervised living setting or participation in formal outpatient adherence programs pregnancy or other medical condition contraindicating use of antipsychotic medications

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile After-Care Support (MACS) app<br>All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and intervention. | Behavioral: Mobile After-Care Support (MACS) app<br>* The MACS app assesses and intervenes by fostering increased treatment adherence (medication/appointments) and self-coping with illness (active, planned, problem-solving focused) to reduce symptoms and improve functioning.<br>|
| Active Comparator: Mobile app attention control<br>All participants download the app to their mobile phone. The app runs through a third-party software platform. It is designed to provide ecological momentary assessment and psychoeducation about illness. | Behavioral: Mobile app attention control<br>* The control app provides ecological momentary assessment and psychoeducation about illness.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Client Satisfaction Questionnaire (CSQ) | The Client Satisfaction Questionnaire is a self-report measure of patient satisfaction with treatment. The total score (sum of items) will be used and ranges from 8 to 32 with increased scores indicating greater satisfaction with treatment. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Psychiatric Rating Scale (BPRS) | The interviewer-rated Brief Psychiatric Rating Scale is a measure of psychiatric symptom severity. The total score (sum of items) will be used to assess overall severity with scores ranging from 18 to 126 and higher scores indicating greater severity. | Baseline, 1 month | 
| Brief Adherence Rating Scale (BARS) | The Brief Adherence Rating Scale assesses the percentage of missed medication doses over the past month. The total adherence score ranges from 0% to 100% and higher scores indicate greater adherence. | Baseline, 1 month | 
| Brief Cope Inventory (Brief COPE) | The Brief Cope Inventory is a 28 item self-report measure of coping skills. The mean values of the total score will be used combining the subscales of emotion-focused strategies, problem-focused strategies, and dysfunctional coping strategies. Mean scores for the total range from 1-4 with higher scores indicating greater use of the coping strategies. | Baseline, 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, psychosis, mHealth, psychiatric hospitalization, treatment adherence, transitions of care, coping skills, psychosocial intervention