Mobile After-Care Support App: Pilot RCT

Not Applicable

Completed

• Conditions: Psychotic Disorder
• Interventions: Behavioral: Mobile app attention control; Behavioral: Mobile After-Care Support (MACS) app

• Registration Number: NCT03955250
• Lead Sponsor: Butler Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-20
• Study Start: 2019-05-31
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Results First Submitted: 2023-07-31
• Results First Submitted QC: 2023-08-01
• Results First Posted: 2023-08-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobile app attention control	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.
Mobile After-Care Support (MACS) app	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.

Primary Outcome Measures

Name	Time	Method
Client Satisfaction Questionnaire (CSQ)	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.

Secondary Outcome Measures

Name	Time	Method
Brief Adherence Rating Scale (BARS)	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.
Brief Psychiatric Rating Scale (BPRS)	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.
Brief Cope Inventory (Brief COPE)	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.

Trial Locations

Locations (1)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States