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| ID | Type | Description | Link |
|---|---|---|---|
| 5P50MH119029-04 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Brown University | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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Investigators are evaluating a Technology Enabled Service (TES) to support the treatment of depression in the context of a collaborative care service in obstetrics clinics.
Investigators are evaluating a Technology Enabled Service (TES) to support the treatment of depression in the context of a collaborative care service in obstetrics clinics. The TES consists of digital technologies that connect patients to care managers remotely, providing tools for monitoring patient symptoms, communication, and delivery of a digital intervention. The intervention consists of a patient-facing app for assessment and self-management of depression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Technology Enabled Service | Experimental | Access to the Intellicare suite of digital mental health self-management tools and coaching |
|
| eTreatment as Usual | Active Comparator | Current care plus access to a website that will provide content specific to perinatal depression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IntelliCare | Behavioral | Application with patient-facing tools for depression symptom monitoring, self-management, and care manager communication as well as care manager dashboards for workflow optimization |
| Measure | Description | Time Frame |
|---|---|---|
| Depression | Assessed by Patient Health Questionnaire-9 Scores range from 0-27. Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. | At 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | Assessed by General Anxiety Disorder - 7 Scores range from 0-21. The following cut-offs correlate with level of anxiety severity: Score 0-4: Minimal Anxiety Score 5-9: Mild Anxiety Score 10-14: Moderate Anxiety Score greater than 15: Severe Anxiety | At 12 weeks |
| Satisfaction Index - Mental Health |
| Measure | Description | Time Frame |
|---|---|---|
| TWente Engagement With Ehealth Technologies Scale (TWEETS) | The TWEETs measures engagement, usability, usefulness, and satisfaction with the digital mental health tool. It includes 9 items rated on 1-5 point likert scales, and produces a total score ranging from 9 to 45. Higher scores indicate better usability. TWEETS scores were analyzed as discrete outcomes at 6 and 12 weeks. Separate analyses were conducted for each time point using the Welch two-sample t-test to compare scores across intervention groups. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Mohr | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prentice Women's Hospital | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Technology Enabled Service | Access to the Intellicare suite of digital mental health self-management tools and coaching IntelliCare: Application with patient-facing tools for depression symptom monitoring, self-management, and care manager communication as well as care manager dashboards for workflow optimization |
| FG001 | eTreatment as Usual | Current care plus access to a website that will provide content specific to perinatal depression COMPASS-Care: Website with content specific to perinatal depression and standard EHR-based tools for patient communication |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Technology Enabled Service | Access to the Intellicare suite of digital mental health self-management tools and coaching IntelliCare: Application with patient-facing tools for depression symptom monitoring, self-management, and care manager communication as well as care manager dashboards for workflow optimization |
| BG001 |
| 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 | Depression | Assessed by Patient Health Questionnaire-9 Scores range from 0-27. Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. | Analysis from all observed data | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | At 12 weeks |
|
Adverse event data were monitored throughout participant involvement in the clinical trial, up to 12 weeks.
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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 | Technology Enabled Service | Access to the Intellicare suite of digital mental health self-management tools and coaching IntelliCare: Application with patient-facing tools for depression symptom monitoring, self-management, and care manager communication as well as care manager dashboards for workflow optimization |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Mohr | Northwestern University | 312-503-1403 | d-mohr@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 2, 2023 | Jul 28, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 15, 2024 | Jul 28, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 7, 2023 | Jul 28, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| COMPASS-Care | Other | Website with content specific to perinatal depression and standard EHR-based tools for patient communication |
|
The Satisfaction Index - Mental Health measures satisfaction with mental health treatment. The measure includes 12 items, each rated on a 1-6 point likert scale (range of 6-72 points for total score) where higher scores reflect higher satisfaction. Scores were analyzed as discrete outcomes at 6 and 12 weeks. Separate analyses were conducted for each time point using the Welch two-sample t-test to compare scores across intervention groups. |
| Week 6, Week 12 |
| Week 6, Week 12 |
| Execution of Stepped Care | Proportion of eligible women engaged in stepped care treatment (# of women who got stepped care / # of women in whom it was indicated (i.e., PHQ9 >=10)) | Up to 12 weeks |
| eTreatment as Usual |
Current care plus access to a website that will provide content specific to perinatal depression COMPASS-Care: Website with content specific to perinatal depression and standard EHR-based tools for patient communication |
| 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 |
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| General Health | Count of Participants | Participants |
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| Engaged in Psychotherapy | Count of Participants | Participants |
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| Using Psychiatric Medications | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Employed | Count of Participants | Participants |
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| Income | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Household Size | Count of Participants | Participants |
|
Current care plus access to a website that will provide content specific to perinatal depression
COMPASS-Care: Website with content specific to perinatal depression and standard EHR-based tools for patient communication
|
|
| Secondary | Anxiety | Assessed by General Anxiety Disorder - 7 Scores range from 0-21. The following cut-offs correlate with level of anxiety severity: Score 0-4: Minimal Anxiety Score 5-9: Mild Anxiety Score 10-14: Moderate Anxiety Score greater than 15: Severe Anxiety | From all observed data | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | At 12 weeks |
|
|
|
| Secondary | Satisfaction Index - Mental Health | The Satisfaction Index - Mental Health measures satisfaction with mental health treatment. The measure includes 12 items, each rated on a 1-6 point likert scale (range of 6-72 points for total score) where higher scores reflect higher satisfaction. Scores were analyzed as discrete outcomes at 6 and 12 weeks. Separate analyses were conducted for each time point using the Welch two-sample t-test to compare scores across intervention groups. | From all observed data | Posted | Median | Inter-Quartile Range | score on a scale | Week 6, Week 12 |
|
|
|
| Other Pre-specified | TWente Engagement With Ehealth Technologies Scale (TWEETS) | The TWEETs measures engagement, usability, usefulness, and satisfaction with the digital mental health tool. It includes 9 items rated on 1-5 point likert scales, and produces a total score ranging from 9 to 45. Higher scores indicate better usability. TWEETS scores were analyzed as discrete outcomes at 6 and 12 weeks. Separate analyses were conducted for each time point using the Welch two-sample t-test to compare scores across intervention groups. | from all observed data | Posted | Median | Inter-Quartile Range | score on a scale | Week 6, Week 12 |
|
|
|
| Other Pre-specified | Execution of Stepped Care | Proportion of eligible women engaged in stepped care treatment (# of women who got stepped care / # of women in whom it was indicated (i.e., PHQ9 >=10)) | Analysis only completed on patients meeting criteria for stepped care, as described. | Posted | Count of Participants | Participants | Up to 12 weeks |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | eTreatment as Usual | Current care plus access to a website that will provide content specific to perinatal depression COMPASS-Care: Website with content specific to perinatal depression and standard EHR-based tools for patient communication | 0 | 37 | 0 | 37 | 0 | 37 |
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