Psychotic Disorders
Conditions
Keywords
Medication adherence, Treatment adherence, Ecological momentary assessment, Ecological momentary intervention, Coping skills, Psychiatric Hospitalization
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.
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.
Interventions
BEHAVIORALMobile 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.
Sponsors
National Institute of Mental Health (NIMH)
Butler Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
An uncontrolled open trial approach will be used in which all participants receive the MACS app.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Client Satisfaction Questionnaire (CSQ) | 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
| Measure | Time frame | Description |
|---|---|---|
| Brief Psychiatric Rating Scale (BPRS) | 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. |
| Brief Adherence Rating Scale (BARS) | 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. |
| Maastricht Assessment of Coping Strategies (MACS) | 1 month | The MACS is an interviewer-rated assessment of the coping strategies that patients report using to manage their symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Mobile After-Care Support (MACS) App |
|---|---|
| Age, Continuous | 44.4 years STANDARD_DEVIATION 13.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 1 / 10 |
Outcome results
Primary
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.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile After-Care Support (MACS) App | Client Satisfaction Questionnaire (CSQ) | 19.2 units on a scale | Standard Deviation 1.6 |
Secondary
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.
Time frame: 1 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mobile After-Care Support (MACS) App | Brief Adherence Rating Scale (BARS) | Baseline | 96.7 score on a scale | Standard Deviation 8.8 |
| Mobile After-Care Support (MACS) App | Brief Adherence Rating Scale (BARS) | 1 Month | 97.5 score on a scale | Standard Deviation 4.6 |
p-value: 0.875t-test, 2 sided
Secondary
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.
Time frame: 1 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mobile After-Care Support (MACS) App | Brief Psychiatric Rating Scale (BPRS) | Baseline | 46.4 score on a scale | Standard Deviation 6.7 |
| Mobile After-Care Support (MACS) App | Brief Psychiatric Rating Scale (BPRS) | 1 Month | 30.4 score on a scale | Standard Deviation 8.5 |
p-value: <0.001t-test, 2 sided
Secondary
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.
Time frame: 1 month
Population: No data were collected for this measure (MACS). This is because we were unable to administer the measure as originally planned.