Psychotic DisordersMACSNCT03769493

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

A study testing Mobile After-Care Support (MACS) app in people with Psychotic Disorders, run by Butler Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Psychotic Disorders
What is being tested?: Mobile After-Care Support (MACS) app
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 16 Jan 2019to 15 Oct 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Butler Hospital
Providence, Rhode Island, 02906

Other trials in United States

About this study

Official title: Mobile After-Care Support Intervention for Patients With Schizophrenia Following Hospitalization (MACS)

Read the 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.

Conditions: Psychotic Disorders
Being tested: Mobile After-Care Support (MACS) app
Keywords: Medication adherence, Treatment adherence, Ecological momentary assessment, Ecological momentary intervention, Coping skills, Psychiatric Hospitalization
Medical subject headings: Psychotic Disorders, Medication Adherence, Treatment Adherence and Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mobile After-Care Support (MACS) appBehavioural
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.

Study groups in NCT03769493
Study group	Role	What they receive
Mobile After-Care Support (MACS) app	Experimental	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. Receives: Behavioral: Mobile After-Care Support (MACS) app

What is being measured

The primary outcome is the main question the study is designed to answer.

Client Satisfaction Questionnaire (CSQ)
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.
Measured: 1 month

Secondary outcomes (3)

Brief Psychiatric Rating Scale (BPRS)
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.
Measured: 1 month
Brief Adherence Rating Scale (BARS)
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.
Measured: 1 month
Maastricht Assessment of Coping Strategies (MACS)
The MACS is an interviewer-rated assessment of the coping strategies that patients report using to manage their symptoms.
Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jan 201915 Oct 2019

First posted7 Dec 2018
Study start16 Jan 2019
Primary completion15 Oct 2019
Study completion15 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Psychotic DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: An uncontrolled open trial approach will be used in which all participants receive the MACS app.
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03769493
Sponsor's protocol ID: 1806-001
Other IDs: R34MH115144
Acronym: MACS
Status last verified: Dec 2022
First submitted: 5 Dec 2018
Last updated: 19 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data available on the National Institute of Mental Health Data Archive (NDA).

Publications

Moitra E, Park HS, Gaudiano BA. Development and Initial Testing of an mHealth Transitions of Care Intervention for Adults with Schizophrenia-Spectrum Disorders Immediately Following a Psychiatric Hospitalization. Psychiatr Q. 2021 Mar;92(1):259-272. doi: 10.1007/s11126-020-09792-9.
PubMed 32613525

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
RecruitingPhase 2/3
ACP-204 in Adults With Alzheimer's Disease Psychosis
Alzheimer's Disease Psychosis

All Psychotic Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mobile After-Care Support Intervention for Patients With Schizophrenia Following Hospitalization (MACS)
ClinicalTrials.gov ID: NCT03769493
Acronym / sponsor ID: MACS / 1806-001
Conditions: Psychotic Disorders
Keywords: Medication adherence, Treatment adherence, Ecological momentary assessment, Ecological momentary intervention, Coping skills, Psychiatric Hospitalization
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Butler HospitalUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 16 Jan 2019 (actual)
Primary completion: 15 Oct 2019 (actual)
Study completion: 15 Oct 2019 (actual)
First posted: 7 Dec 2018 (actual)
Results: Posted 19 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: An uncontrolled open trial approach will be used in which all participants receive the MACS app.

Arm	Type	Receives
Mobile After-Care Support (MACS) app	Experimental	Behavioral: Mobile After-Care Support (MACS) appAll 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mobile After-Care Support (MACS) appThe 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.	Behavioural	Mobile After-Care Support (MACS) app

Primary outcome

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.

3 secondary outcomes

Brief Psychiatric Rating Scale (BPRS)
Time frame: 1 month
Brief Adherence Rating Scale (BARS)
Time frame: 1 month
Maastricht Assessment of Coping Strategies (MACS)
Time frame: 1 month

Results and safety

Results posted to the registry on 19 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mobile After-Care Support (MACS) App	10	7

Primary outcome: Client Satisfaction Questionnaire (CSQ)

Time frame: 1 month. Mean (Standard Deviation). Unit: units on a scale

Measure	Mobile After-Care Support (MACS) App n = 7
Value	19.2 (1.6)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mobile After-Care Support (MACS) App	1 of 10 (10%)	0 of 10 (0%)	0 of 10

Limitations and caveats (from the sponsor): This is a treatment development study and therefore was not designed to test the efficacy of the intervention given the small sample size. Instead, the goal was examine feasibility and acceptability.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 32613525Moitra E, Park HS, Gaudiano BA. Development and Initial Testing of an mHealth Transitions of Care Intervention for Adults with Schizophrenia-Spectrum Disorders Immediately Following a Psychiatric Hospitalization. Psychiatr Q. 2021 Mar;92(1):259-272. doi: 10.1007/s11126-020-09792-9.
Development and initial testing of an mHealth transitions of care intervention for adults with schizophrenia-spectrum disorders immediately following a psychiatric hospitalizationLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Data available on the National Institute of Mental Health Data Archive (NDA).

Related trials for Psychotic Disorders

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
RecruitingPhase 2/3
ACP-204 in Adults With Alzheimer's Disease Psychosis
Alzheimer's Disease Psychosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brandon A Gaudiano, Ph.D. principal investigator

Butler Hospital & Brown Universit

Ethan Moitra, Ph.D. principal investigator

Brown University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mobile After-Care Support (MACS) app in people with Psychotic Disorders, run by Butler Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Client Satisfaction Questionnaire (CSQ) (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03769493, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2023.