Mobile After-Care Support App: Pilot RCT (MACS-RCT)
February 19, 2024 updated by: Butler Hospital
Mobile After-Care Support Intervention for Patients With Schizophrenia Following Hospitalization: Pilot RCT
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02916
- Butler Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mobile After-Care Support (MACS) app
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.
|
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.
|
|
Active Comparator: Mobile app attention control
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.
|
The control app provides ecological momentary assessment and psychoeducation about illness.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Client Satisfaction Questionnaire (CSQ)
Time Frame: 1 month
|
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)
Time Frame: Baseline, 4 month
|
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, 4 month
|
|
Brief Adherence Rating Scale (BARS)
Time Frame: Baseline, 4 month
|
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, 4 month
|
|
Brief Cope Inventory (Brief COPE)
Time Frame: Baseline, 4 month
|
The Brief Cope Inventory is a 28 item self-report measure of coping skills.
The mean values of the 12-item dysfunctional coping subscale was used.
Mean scores for the total range from 1-48 with higher scores indicating greater use of the dysfunctional coping strategies.
|
Baseline, 4 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Brandon Gaudiano, PhD, Butler Hospital
- Principal Investigator: Ethan Moitra, PhD, Brown University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 31, 2019
Primary Completion (Actual)
May 31, 2022
Study Completion (Actual)
May 31, 2022
Study Registration Dates
First Submitted
May 16, 2019
First Submitted That Met QC Criteria
May 16, 2019
First Posted (Actual)
May 20, 2019
Study Record Updates
Last Update Posted (Actual)
March 19, 2024
Last Update Submitted That Met QC Criteria
February 19, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1905-001
- R34MH115144 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Uploaded to NIMH Data Archive
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.