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This 2-arm clinical trial piloted a mobile Self-Management of Schizophrenia (SOS) system that administers interventions targeting persistent symptoms of psychosis, social dysfunction, and medication adherence. Researchers compared an intervention arm using the SOS system and an arm receiving treatment as usual on the outcomes of change in severity of psychotic symptoms and change in social functioning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as Usual | Active Comparator | Treatment as usual includes outpatient case management, linkage to services and medication monitoring. |
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| Mobile Application | Experimental | Mobile Application system designed to improve coping with psychotic symptoms, social functioning, and medication adherence. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Application | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Severity of Psychotic Symptoms | Severity of Psychotic Symptoms was assessed with the Psychotic Symptom Rating Scales (PSYRATS). The PSYRATS is comprised of 17 items inquiring about the specific dimensions of hallucinations and delusions, with each item being rated from 0 (absent) to 4 (severe). The PSYRATS has 2 subscales: the auditory hallucinations subscale (AHS) consisting of 11 items, and the delusions subscale (DS) consisting of 6 items. These subscale scores are added to create a total score ranging from 0-68. Higher scores indicate worse symptoms. | Baseline, week 12 |
| Change in Social Functioning | Social Functioning was measured using two subscales from the Social Functioning Scale (SFS): Social Engagement (5-items) and Withdrawal & Communication (10-items). The item values range from 0 (almost never) to 3 (often). The two subscales were summed to give a score between 0-45. A higher score indicates greater social functioning. | Baseline, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in System Use | System use was measured by the SOS application regarding the percent of SOS prompts and self-report interactions with the system. | 4 weeks |
| Usability and Satisfaction | Usability and Satisfaction was measured using the USE (Usefulness, Satisfaction, and Ease of use) Questionnaire, which was designed to measure satisfaction, usefulness, ease of use and ease of learning. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dror Ben-Zeev, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Mental Health Center of Greater Manchester | Manchester | New Hampshire | 03103 | United States |
N=3 enrolled participants were not assigned because N=1 did not pass a competency screener, N=1 did not meet Recovery Assessment Scale inclusion criteria, and N= 1 was no longer interested prior to completing baseline.
Individuals with schizophrenia or schizoaffective disorder who were receiving services were recruited through flyers in waiting rooms and bulletin boards at treatment centers, and through referrals from clinical staff. Enrollment was open from November 2015 to July 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment as Usual | Treatment as usual includes outpatient case management, linkage to services and medication monitoring. Treatment as Usual |
| FG001 | Mobile Application | Mobile Application system designed to improve coping with psychotic symptoms, social functioning, and medication adherence. Mobile Application |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment as Usual | Treatment as usual includes outpatient case management, linkage to services and medication monitoring. Treatment as Usual |
| BG001 | Mobile Application | Mobile Application system designed to improve coping with psychotic symptoms, social functioning, and medication adherence. Mobile Application |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Severity of Psychotic Symptoms | Severity of Psychotic Symptoms was assessed with the Psychotic Symptom Rating Scales (PSYRATS). The PSYRATS is comprised of 17 items inquiring about the specific dimensions of hallucinations and delusions, with each item being rated from 0 (absent) to 4 (severe). The PSYRATS has 2 subscales: the auditory hallucinations subscale (AHS) consisting of 11 items, and the delusions subscale (DS) consisting of 6 items. These subscale scores are added to create a total score ranging from 0-68. Higher scores indicate worse symptoms. | N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI. | Posted | Mean | Standard Error | units on a scale | Baseline, week 12 |
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Assessed at the baseline and 12 week assessments for each participant.
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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 | Treatment as Usual | Treatment as usual includes outpatient case management, linkage to services and medication monitoring. Treatment as Usual |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dror Ben-Zeev | University of Washington | (206) 685-9655 | dbenzeev@uw.edu |
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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 | Jul 25, 2018 | Jul 26, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as Usual (TAU) |
| Behavioral |
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| 4 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Beliefs about Medicines Questionnaire - General (BMQ - General) | The Beliefs about Medicine Questionnaire - General (BMQ - General) comprises two 4-item factors with 5-point Likert scales assessing beliefs that medicines are harmful, addictive, poisons which should not be taken continuously and that medicines are overused by doctors. Total scores range from 8-40. Higher scores indicate more negative beliefs about medicines. | N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI. | Mean | Standard Deviation | units on a scale |
|
| Beliefs about Medicines Questionnaire - Specific (BMQ - Specific) | The Beliefs about Medicines Questionnaire - Specific (BMQ - Specific) comprises two 5-item factors with 5-point Likert scales assessing beliefs about the necessity of prescribed medication and concerns about prescribed medication based on beliefs about the danger of dependence, long-term toxicity, and the disruptive effects of medication. Total scores range from 10-50. Higher scores represent more negative beliefs about taking prescribed medication. | N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI. | Mean | Standard Deviation | units on a scale |
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| Schizophrenia Patient Activation Measure (SPAM) | The Schizophrenia Patient Activation Measure (SPAM) is an adaptation of the Patient Activation Measure (PAM). This measure is 14 items with 5-point Likert responses. It measures confidence in self-management and understanding of the participant's schizophrenia. Scores range from 14-70. Higher scores indicate more confidence in self-management and understanding of the participant's schizophrenia. | N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI. | Mean | Standard Deviation | units on a scale |
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| Beck Depression Inventory (BDI) | The Beck Depression Inventory (BDI) is a psychometric test for measuring the severity of depression with 21 questions on a 4-point scale. The scores range from 0-63. Higher scores indicate more severe depressive symptoms. | N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI. | Mean | Standard Deviation | units on a scale |
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| Insomnia Severity Index (ISI) | Insomnia Severity Index (ISI) is a 7-item, 5-point Likert scale self-report instrument measuring the participant's perception of his or her insomnia. Scores range from 0 to 28. Higher scores indicate the participant perceives his or her insomnia as more severe. | Mean | Standard Deviation | units on a scale |
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| Working Alliance Inventory (WAI) | The Working Alliance Inventory (WAI) is a 12-item scale with 7-point Likert responses that provides an overall measure of alliance between patients and clinical support workers. Scores can range from 12 to 84. Higher scores indicate a better alliance between the patient and the clinical support worker. | N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI. | Mean | Standard Deviation | units on a scale |
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| OG001 | Mobile Application | Mobile Application system designed to improve coping with psychotic symptoms, social functioning, and medication adherence. Mobile Application |
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| Primary | Change in Social Functioning | Social Functioning was measured using two subscales from the Social Functioning Scale (SFS): Social Engagement (5-items) and Withdrawal & Communication (10-items). The item values range from 0 (almost never) to 3 (often). The two subscales were summed to give a score between 0-45. A higher score indicates greater social functioning. | N=1 participant in the mobile application arm did not complete the baseline assessment and is not included in analysis for all measures except ISI. | Posted | Mean | Standard Error | units on a scale | Baseline, week 12 |
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| Secondary | Change in System Use | System use was measured by the SOS application regarding the percent of SOS prompts and self-report interactions with the system. | This data was collected in a previous field trial, not in this randomized controlled trial. | Posted | 4 weeks |
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| Secondary | Usability and Satisfaction | Usability and Satisfaction was measured using the USE (Usefulness, Satisfaction, and Ease of use) Questionnaire, which was designed to measure satisfaction, usefulness, ease of use and ease of learning. | This data was collected in a previous field trial, not in this randomized controlled trial. | Posted | 4 weeks |
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| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Mobile Application | Mobile Application system designed to improve coping with psychotic symptoms, social functioning, and medication adherence. Mobile Application | 1 | 26 | 0 | 26 | 0 | 26 |
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| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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