Back to resultsMobile After-Care Support App: Pilot RCT (MACS-RCT)
Primary Purpose
Psychotic Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile After-Care Support (MACS) app
Mobile app attention control
Sponsored by
About this trial
This is an interventional treatment trial for Psychotic Disorder focused on measuring schizophrenia, psychosis, mHealth, psychiatric hospitalization, treatment adherence, transitions of care, coping skills, psychosocial intervention
Eligibility Criteria
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
Sites / Locations
- Butler Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mobile After-Care Support (MACS) app
Mobile app attention control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT03955250
First Posted
May 16, 2019
Last Updated
August 1, 2023
Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03955250
Brief Title
Mobile After-Care Support App: Pilot RCT
Acronym
MACS-RCT
Official Title
Mobile After-Care Support Intervention for Patients With Schizophrenia Following Hospitalization: Pilot RCT
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 31, 2019 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorder
Keywords
schizophrenia, psychosis, mHealth, psychiatric hospitalization, treatment adherence, transitions of care, coping skills, psychosocial intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile After-Care Support (MACS) app
Arm Type
Experimental
Arm Description
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.
Arm Title
Mobile app attention control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mobile After-Care Support (MACS) app
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mobile app attention control
Intervention Description
The control app provides ecological momentary assessment and psychoeducation about illness.
Primary Outcome Measure Information:
Title
Client Satisfaction Questionnaire (CSQ)
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Brief Psychiatric Rating Scale (BPRS)
Description
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.
Time Frame
Baseline, 1 month
Title
Brief Adherence Rating Scale (BARS)
Description
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.
Time Frame
Baseline, 1 month
Title
Brief Cope Inventory (Brief COPE)
Description
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.
Time Frame
Baseline, 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon Gaudiano, PhD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ethan Moitra, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02916
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Uploaded to NIMH Data Archive
Learn more about this trial
Mobile After-Care Support App: Pilot RCT
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