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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH115144 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile After-Care Support (MACS) app | Experimental | 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. |
|
| Mobile app attention control | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Client Satisfaction Questionnaire (CSQ) | 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Psychiatric Rating Scale (BPRS) | 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. | Baseline, 4 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brandon Gaudiano, PhD | Butler Hospital | Principal Investigator |
| Ethan Moitra, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butler Hospital | Providence | Rhode Island | 02916 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38842850 | Derived | 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. |
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Uploaded to NIMH Data Archive
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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 app attention control: The control app provides ecological momentary assessment and psychoeducation about illness. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Client Satisfaction Questionnaire (CSQ) | 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. | The number of participants analyzed is lower than the number enrolled due to missing data on this measure. | Posted | Mean | Standard Deviation | score on a scale | 1 month |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rehospitalization | Psychiatric disorders | Systematic Assessment |
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This was a pilot RCT and therefore was designed to assess feasibility and acceptability of the intervention in preparation for a larger clinical trial. It was not powered to test comparative efficacy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brandon Gaudiano, Ph.D. | Butler Hospital | 401-455-6457 | BGaudiano@Butler.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2021 | Jul 29, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000682 | Amyloid |
| ID | Term |
|---|---|
| D046912 | Multiprotein Complexes |
| D046911 | Macromolecular Substances |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Mobile app attention control | Behavioral | The control app provides ecological momentary assessment and psychoeducation about illness. |
|
| Brief Adherence Rating Scale (BARS) |
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. |
| Baseline, 4 month |
| Brief Cope Inventory (Brief COPE) | 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. | Baseline, 4 month |
| BG001 | 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 app attention control: The control app provides ecological momentary assessment and psychoeducation about illness. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | 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 app attention control: The control app provides ecological momentary assessment and psychoeducation about illness. |
|
|
|
| Secondary | Brief Psychiatric Rating Scale (BPRS) | 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. | This analysis was intent-to-treat based on all participants initially enrolled in the study. | Posted | Mean | Standard Error | score on a scale | Baseline, 4 month |
|
|
|
|
| Secondary | Brief Adherence Rating Scale (BARS) | 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. | This analysis was intent-to-treat based on all participants initially enrolled in the study. | Posted | Mean | Standard Error | units on a scale | Baseline, 4 month |
|
|
|
|
| Secondary | Brief Cope Inventory (Brief COPE) | 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. | This analysis was intent-to-treat based on all participants initially enrolled in the study. | Posted | Mean | Standard Error | score on a scale | Baseline, 4 month |
|
|
|
|
| 0 |
| 19 |
| 11 |
| 19 |
| 0 |
| 19 |
| EG001 | 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 app attention control: The control app provides ecological momentary assessment and psychoeducation about illness. | 0 | 23 | 9 | 23 | 0 | 23 |
| Suicide attempt | Psychiatric disorders | Systematic Assessment |
|
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| >0.05 |
| Superiority |
| 4 Month |
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|
| >0.05 |
| Superiority |
| >0.05 |
| Superiority |