Psychotic Disorder
Conditions
Keywords
schizophrenia, psychosis, mHealth, psychiatric hospitalization, treatment adherence, transitions of care, coping skills, psychosocial intervention
Brief summary
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.
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.
BEHAVIORALMobile app attention control
The control app provides ecological momentary assessment and psychoeducation about illness.
Sponsors
National Institute of Mental Health (NIMH)
Butler Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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 (sum of items) 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) | 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. |
| Brief Adherence Rating Scale (BARS) | 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. |
| Brief Cope Inventory (Brief COPE) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 19 |
| 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. | 23 |
| Total | 42 |
Baseline characteristics
| Characteristic | Mobile After-Care Support (MACS) App | Total | Mobile App Attention Control |
|---|---|---|---|
| Age, Continuous | 32.6 years STANDARD_DEVIATION 11.7 | 34.3 years STANDARD_DEVIATION 11.4 | 35.1 years STANDARD_DEVIATION 11.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 10 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 32 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 10 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 26 Participants | 13 Participants |
| Region of Enrollment United States | 19 participants | 42 participants | 23 participants |
| Sex: Female, Male Female | 8 Participants | 16 Participants | 8 Participants |
| Sex: Female, Male Male | 11 Participants | 26 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 23 |
| other Total, other adverse events | 0 / 19 | 0 / 23 |
| serious Total, serious adverse events | 11 / 19 | 9 / 23 |
Outcome results
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.
Time frame: 1 month
Population: The number of participants analyzed is lower than the number enrolled due to missing data on this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mobile After-Care Support (MACS) App | Client Satisfaction Questionnaire (CSQ) | 23.7 score on a scale | Standard Deviation 4.4 |
| Mobile App Attention Control | Client Satisfaction Questionnaire (CSQ) | 22.5 score on a scale | Standard Deviation 7.6 |
p-value: >0.05t-test, 2 sided
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.
Time frame: Baseline, 4 month
Population: This analysis was intent-to-treat based on all participants initially enrolled in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mobile After-Care Support (MACS) App | Brief Adherence Rating Scale (BARS) | Baseline | 86.2 units on a scale | Standard Error 4.8 |
| Mobile After-Care Support (MACS) App | Brief Adherence Rating Scale (BARS) | 4 Month | 94.4 units on a scale | Standard Error 4.9 |
| Mobile App Attention Control | Brief Adherence Rating Scale (BARS) | Baseline | 83.8 units on a scale | Standard Error 4.4 |
| Mobile App Attention Control | Brief Adherence Rating Scale (BARS) | 4 Month | 92.0 units on a scale | Standard Error 4.8 |
p-value: >0.05t-test, 2 sided
p-value: >0.05t-test, 2 sided
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.
Time frame: Baseline, 4 month
Population: This analysis was intent-to-treat based on all participants initially enrolled in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mobile After-Care Support (MACS) App | Brief Cope Inventory (Brief COPE) | 4 Month | 24.8 score on a scale | Standard Error 1.7 |
| Mobile After-Care Support (MACS) App | Brief Cope Inventory (Brief COPE) | Baseline | 28.6 score on a scale | Standard Error 1.6 |
| Mobile App Attention Control | Brief Cope Inventory (Brief COPE) | 4 Month | 24.4 score on a scale | Standard Error 1.7 |
| Mobile App Attention Control | Brief Cope Inventory (Brief COPE) | Baseline | 28.1 score on a scale | Standard Error 1.5 |
p-value: <0.05t-test, 2 sided
p-value: >0.05t-test, 2 sided
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.
Time frame: Baseline, 4 month
Population: This analysis was intent-to-treat based on all participants initially enrolled in the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mobile After-Care Support (MACS) App | Brief Psychiatric Rating Scale (BPRS) | Baseline | 53.1 score on a scale | Standard Error 2.4 |
| Mobile After-Care Support (MACS) App | Brief Psychiatric Rating Scale (BPRS) | 4 Month | 36.4 score on a scale | Standard Error 2.6 |
| Mobile App Attention Control | Brief Psychiatric Rating Scale (BPRS) | Baseline | 49.8 score on a scale | Standard Error 2.2 |
| Mobile App Attention Control | Brief Psychiatric Rating Scale (BPRS) | 4 Month | 33.1 score on a scale | Standard Error 2.6 |
p-value: <0.05t-test, 2 sided
p-value: >0.05t-test, 2 sided