Mobile After-Care Support App: Pilot RCT

Psychotic Disorder Clinical Trial

— MACS-RCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03955250
• Other study ID #: 1905-001
• Secondary ID: R34MH115144
• Status: Completed
• Phase: N/A
• Start date: May 31, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: February 2024
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorder
• Psychotic Disorders

Intervention

Behavioral:
• Mobile After-Care Support (MACS) app
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.
• Mobile app attention control
The control app provides ecological momentary assessment and psychoeducation about illness.

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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, 4 month
Secondary	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, 4 month
Secondary	Brief Cope Inventory (Brief COPE)	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