Working... Menu

Mobile After-Care Intervention to Support Post-Hospital Transition (MACS) (MACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03769493
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : January 29, 2019
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Brandon Gaudiano, Butler Hospital

Brief Summary:
This study examines the feasibility and acceptability of a 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.

Condition or disease Intervention/treatment Phase
Psychotic Disorders Behavioral: Mobile After-Care Support (MACS) app Not Applicable

Detailed Description:
In the open trial, all participants will receive a study-developed app to be used on a mobile phone. This app will support the use of healthy coping skills post-hospitalization, as well as help participants adhere to their discharge treatment plan. This phase is intended to inform the feasibility and acceptability of the app in preparation for a future randomized controlled trial.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: An uncontrolled open trial approach will be used in which all participants receive the MACS app.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mobile After-Care Support Intervention for Patients With Schizophrenia Following Hospitalization (MACS)
Actual Study Start Date : January 16, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Mobile After-Care Support (MACS) app
All participants will download the MACS app to their mobile phone (or a study provided phone, as needed). The app runs through the third-party platform, mEMA, designed by Ilumivu. It is designed to prompt engagement through questions and tailored responses at multiple times throughout the day and provide brief interventions.
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. Additionally, MACS encourages participants who are already reporting adherence and healthy coping by using positive reinforcement strategies to maintain efforts and promote additional goal setting. MACS app strategies are linked to participants' specific assessment responses, allowing for a highly personalized self-management intervention experience. The MACS app provides interactive exercises delivered by the device designed to teach patients coping skills that they can use now and in the future.

Primary Outcome Measures :
  1. 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 will be used and ranges from 8 to 32 with increased scores indicating greater satisfaction with treatment.

Secondary Outcome Measures :
  1. Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 1 month ]
    The interviewer-rated BPRS is a measure of psychiatric symptom severity. The total score will be used to assess overall severity with scores ranging from 18 to 126 and higher scores indicating greater severity.

  2. Brief Adherence Rating Scale (BARS) [ Time Frame: 1 month ]
    The BARS 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.

  3. Maastricht Assessment of Coping Strategies (MACS) [ Time Frame: 1 month ]
    The MACS is an interviewer-rated assessment of the coping strategies that patients report using to manage their symptoms.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Currently hospitalized
  2. DSM-5 criteria for psychotic disorder (schizophrenia or schizoaffective disorder)
  3. 18 years or older
  4. Prescribed oral antipsychotic medication upon discharge
  5. Ability to speak and read English

Exclusion Criteria:

  1. Alcohol/drug use disorders at moderate or severe level
  2. Planned discharge to supervised living setting or participation in formal outpatient adherence programs (e.g., medication packaging)
  3. Pregnancy or other medical condition (e.g., dementia) contraindicating use of antipsychotic medications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03769493

Layout table for location contacts
Contact: Brandon A Gaudiano, Ph.D. (401) 455-6457
Contact: Hyun Seon Park (401) 680-4251

Layout table for location information
United States, Rhode Island
Butler Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Cheryl Cordeiro    401-455-6654   
Principal Investigator: Brandon A Gaudiano, Ph.D.         
Sponsors and Collaborators
Butler Hospital
National Institute of Mental Health (NIMH)
Layout table for investigator information
Principal Investigator: Brandon A Gaudiano, Ph.D. Butler Hospital & Brown Universit
Principal Investigator: Ethan Moitra, Ph.D. Brown University

Layout table for additonal information
Responsible Party: Brandon Gaudiano, Research Psychologist, Butler Hospital Identifier: NCT03769493     History of Changes
Other Study ID Numbers: 1806-001
R34MH115144 ( U.S. NIH Grant/Contract )
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brandon Gaudiano, Butler Hospital:
Medication adherence
Treatment adherence
Ecological momentary assessment
Ecological momentary intervention
Coping skills
Psychiatric Hospitalization

Additional relevant MeSH terms:
Layout table for MeSH terms
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders