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Testing an mHealth mobile interventionist texting program on illness management.
The ultimate objective is to evaluate a validated mHealth intervention that can be realistically integrated into community mental health settings to increase the availability, reach, and broad impact of illness management approaches for people with serious mental illness (SMI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as Usual | No Intervention | Treatment as usual for 3 months. | |
| Mobile Interventionist | Experimental | Participants will exchange text messages with a mobile interventionist throughout the day for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Interventionist | Other | A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones) |
| Measure | Description | Time Frame |
|---|---|---|
| Psychiatric Symptoms | Assessed with the Psychotic Symptom Rating Scales (PSYRATS). The PSYRATS inquires about the specific dimensions of hallucinations and delusions. There are 17 items and each item is 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. | Change from baseline to 3 months and 6 months |
| Psychiatric Symptoms | Assessed with the Beck Depression Inventory (BDI). The Beck Depression Inventory is a psychometric test for measuring the severity of depression. There are 21 items, each rated from 0-3, and total scores range from 0-63. Higher scores indicate more severe depressive symptoms. | Change from baseline to 3 months and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery | Assessed with the Recovery Assessment Scale (RAS). This scale measures mental health recovery. There are 24 items, each rated from 1 (disagree) to 5 (agree), and total scores range from 24-120. Higher scores indicate better recovery. | Change from baseline to 3 months and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction With Treatment | Assessed with satisfaction items established from previous SMI research. This measure consists of 5 items, each rated from 1 (strongly disagree) to 7 (strongly agree), and total scores range from 5-35. Higher scores indicate more satisfaction with treatment. | 3 months |
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 |
|---|---|---|---|---|---|---|
| Thresholds | Chicago | Illinois | 60290 | United States | ||
| Frontier Behavioral Health |
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No significant events to report that occurred after participant enrollment but prior to assignment of participants to an arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment as Usual | Treatment as usual for 3 months. |
| FG001 | Mobile Interventionist | Participants will exchange text messages with a mobile interventionist throughout the day for 3 months. Mobile Interventionist: A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment as Usual | Treatment as usual for 3 months. |
| BG001 | Mobile Interventionist | Participants will exchange text messages with a mobile interventionist throughout the day for 3 months. Mobile Interventionist: A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones) |
| 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 | Psychiatric Symptoms | Assessed with the Psychotic Symptom Rating Scales (PSYRATS). The PSYRATS inquires about the specific dimensions of hallucinations and delusions. There are 17 items and each item is 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to 3 months and 6 months |
|
6 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 | Treatment as Usual | Treatment as usual for 3 months. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | 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 | Oct 9, 2020 | Oct 9, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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| Spokane |
| Washington |
| 99207 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants will exchange text messages with a mobile interventionist throughout the day for 3 months.
Mobile Interventionist: A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)
|
|
| Primary | Psychiatric Symptoms | Assessed with the Beck Depression Inventory (BDI). The Beck Depression Inventory is a psychometric test for measuring the severity of depression. There are 21 items, each rated from 0-3, and total scores range from 0-63. Higher scores indicate more severe depressive symptoms. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to 3 months and 6 months |
|
|
|
| Secondary | Recovery | Assessed with the Recovery Assessment Scale (RAS). This scale measures mental health recovery. There are 24 items, each rated from 1 (disagree) to 5 (agree), and total scores range from 24-120. Higher scores indicate better recovery. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline to 3 months and 6 months |
|
|
|
| Other Pre-specified | Satisfaction With Treatment | Assessed with satisfaction items established from previous SMI research. This measure consists of 5 items, each rated from 1 (strongly disagree) to 7 (strongly agree), and total scores range from 5-35. Higher scores indicate more satisfaction with treatment. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Mobile Interventionist | Participants will exchange text messages with a mobile interventionist throughout the day for 3 months. Mobile Interventionist: A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones) | 0 | 37 | 0 | 37 | 0 | 37 |
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| D003866 | Depressive Disorder |
| Score at 6 Months |
|
| Score at 6 Months |
|