Mobile After-Care Support App: Pilot RCT

NCT ID: NCT03955250

Last Updated: 2024-03-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-31

Study Completion Date

2022-05-31

Brief Summary

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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

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Conditions

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Psychotic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Mobile After-Care Support (MACS) app

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Mobile app attention control

Intervention Type BEHAVIORAL

The control app provides ecological momentary assessment and psychoeducation about illness.

Interventions

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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.

Intervention Type BEHAVIORAL

Mobile app attention control

The control app provides ecological momentary assessment and psychoeducation about illness.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Butler Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brandon Gaudiano, PhD

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital

Ethan Moitra, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

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Butler Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38842850 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R34MH115144

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1905-001

Identifier Type: -

Identifier Source: org_study_id

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