Mobile After-Care Support App: Pilot RCT
MACS-RCT
Mobile After-Care Support Intervention for Patients With Schizophrenia Following Hospitalization: Pilot RCT
2 other identifiers
interventional
42
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2019
CompletedFirst Posted
Study publicly available on registry
May 20, 2019
CompletedStudy Start
First participant enrolled
May 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedResults Posted
Study results publicly available
August 2, 2023
CompletedMarch 19, 2024
February 1, 2024
3 years
May 16, 2019
July 31, 2023
February 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Brief Psychiatric Rating Scale (BPRS)
Baseline, 4 month
Brief Adherence Rating Scale (BARS)
Baseline, 4 month
Brief Cope Inventory (Brief COPE)
Baseline, 4 month
Study Arms (2)
Mobile After-Care Support (MACS) app
EXPERIMENTALAll 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.
Mobile app attention control
ACTIVE COMPARATORAll 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.
Interventions
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.
The control app provides ecological momentary assessment and psychoeducation about illness.
Eligibility Criteria
You may qualify if:
- recently hospitalized
- DSM-5 criteria for psychotic-spectrum disorder based on structured clinical interview
- years or older
- prescribed antipsychotic medication upon discharge
- ability to speak and read English
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Butler Hospitallead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Butler Hospital
Providence, Rhode Island, 02916, United States
Related Publications (1)
Gaudiano BA, Ward M, Benz MB, Hughes C, Johnson JE, Moitra E. Feasibility and acceptability of a mobile intervention for patients with psychosis following psychiatric hospitalization: A pilot randomized controlled trial. Psychol Serv. 2025 May;22(2):221-231. doi: 10.1037/ser0000869. Epub 2024 Jun 6.
PMID: 38842850DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This was a pilot RCT and therefore was designed to assess feasibility and acceptability of the intervention in preparation for a larger clinical trial. It was not powered to test comparative efficacy.
Results Point of Contact
- Title
- Brandon Gaudiano, Ph.D.
- Organization
- Butler Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Brandon Gaudiano, PhD
Butler Hospital
- PRINCIPAL INVESTIGATOR
Ethan Moitra, PhD
Brown University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2019
First Posted
May 20, 2019
Study Start
May 31, 2019
Primary Completion
May 31, 2022
Study Completion
May 31, 2022
Last Updated
March 19, 2024
Results First Posted
August 2, 2023
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
Uploaded to NIMH Data Archive