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Completed

NCT Number: NCT03955250

Mobile After-Care Support App: Pilot RCT

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.

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Key information

Conditions

Psychotic Disorder Behavior Health Behavior Mental Disorders Psychotic Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02916, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile After-Care Support (MACS) app

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

Behavioral

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

Primary outcomes

  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 (sum of items) will be used and ranges from 8 to 32 with increased scores indicating greater satisfaction with treatment.

Secondary outcomes

  1. Brief Psychiatric Rating Scale (BPRS)

    Time frame: 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.

  2. Brief Adherence Rating Scale (BARS)

    Time frame: 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.

  3. Brief Cope Inventory (Brief COPE)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: MACS-RCT

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 20, 2019
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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