| Primary | Hamilton Rating Scale for Depression (HAM-D) | Measure of depression. This is a 6-item questionnaire, where total scores range from 0 to 22, with higher scores indicating greater severity of depression. | One participant missing data at Week 8 | Posted | | Mean | Standard Deviation | score on a scale | | Change from Baseline to Post-treatment at Week 8 | | | | ID | Title | Description |
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| OG000 | WB001 With Adjunctive Treatment as Usual | Participants randomized to the WB001 + TAU group will be asked to download and use the study application. WB001: WB001 is a digital therapeutic for postpartum depression. | | OG001 | Educational Control (ED001) With Adjunctive Treatment as Usual | Participants randomized to the ED001 + TAU group will be asked to download and use the study application. ED001: ED001 is a digital therapeutic for postpartum depression. |
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| Secondary | Edinburgh Postpartum Depression Scale (EPDS) | Measure of postpartum depression. A 10-item self-report questionnaire that assesses depression criteria and yields a total score from 0 to 30 where higher scores denote greater depression. | | Posted | | Mean | Standard Deviation | score on a scale | | Change Baseline to Post-treatment at Week 8 | | | | ID | Title | Description |
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| OG000 | WB001 With Adjunctive Treatment as Usual | Participants randomized to the WB001 + TAU group will be asked to download and use the study application. WB001: WB001 is a digital therapeutic for postpartum depression. | | OG001 | Educational Control (ED001) With Adjunctive Treatment as Usual | Participants randomized to the ED001 + TAU group will be asked to download and use the study application. ED001: ED001 is a digital therapeutic for postpartum depression. |
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| Secondary | Patient Health Questionnaire (PHQ-9) | Measure of depression. A 9-item self-report questionnaire where total scores range from 0 to 27, with higher scores indicating greater levels of depression | | Posted | | Mean | Standard Deviation | score on a scale | | Change Baseline to Post-treatment at Week 8 | | | | ID | Title | Description |
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| OG000 | WB001 With Adjunctive Treatment as Usual | Participants randomized to the WB001 + TAU group will be asked to download and use the study application. WB001: WB001 is a digital therapeutic for postpartum depression. | | OG001 | Educational Control (ED001) With Adjunctive Treatment as Usual | Participants randomized to the ED001 + TAU group will be asked to download and use the study application. ED001: ED001 is a digital therapeutic for postpartum depression. |
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| Secondary | Generalized Anxiety Disorder Questionnaire (GAD-7) | Measure of anxiety. A 7-item brief self-report questionnaire, where total score range is between 0-21, with higher scores indicate greater levels of anxiety. | | Posted | | Mean | Standard Deviation | score on a scale | | Change from Baseline to Post-treatment at Week 8 | | | | ID | Title | Description |
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| OG000 | WB001 With Adjunctive Treatment as Usual | Participants randomized to the WB001 + TAU group will be asked to download and use the study application. WB001: WB001 is a digital therapeutic for postpartum depression. | | OG001 | Educational Control (ED001) With Adjunctive Treatment as Usual | Participants randomized to the ED001 + TAU group will be asked to download and use the study application. ED001: ED001 is a digital therapeutic for postpartum depression. |
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| Secondary | Mother-to-Infant Bonding Scale (MIBS) | Measure of mother-infant bond. An 8-item self-report questionnaire, where total scores range from 0 to 24, with lower scores indicating good bonding. | | Posted | | Mean | Standard Deviation | score on a scale | | Change from Baseline to Post-treatment at Week 8 | | | | ID | Title | Description |
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| OG000 | WB001 With Adjunctive Treatment as Usual | Participants randomized to the WB001 + TAU group will be asked to download and use the study application. WB001: WB001 is a digital therapeutic for postpartum depression. | | OG001 | Educational Control (ED001) With Adjunctive Treatment as Usual | Participants randomized to the ED001 + TAU group will be asked to download and use the study application. ED001: ED001 is a digital therapeutic for postpartum depression. |
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| Secondary | Clinical Global Impressions Scale - Severity of Illness (CGI-S) | Measure of overall severity of current clinical presentation and symptomatology. A single item, 7-point Likert scale on which the investigator will rate patients' severity of illness based on clinical interviews and assessments relative to their experience with other patients with the same diagnosis. Responses include 0 (not assessed) and range from 1 (Normal, not at all ill) to 7 (Among the most extremely ill). | | Posted | | Mean | Standard Deviation | score on a scale | | Change Baseline to Post-treatment at Week 8 | | | | ID | Title | Description |
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| OG000 | WB001 With Adjunctive Treatment as Usual | Participants randomized to the WB001 + TAU group will be asked to download and use the study application. WB001: WB001 is a digital therapeutic for postpartum depression. | | OG001 | Educational Control (ED001) With Adjunctive Treatment as Usual | Participants randomized to the ED001 + TAU group will be asked to download and use the study application. ED001: ED001 is a digital therapeutic for postpartum depression. |
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| Secondary | Clinical Global Impressions Scale - Global Improvement (CGI-I) | Measure of improvement. A single item, 7-point Likert scale that assesses the overall improvement in patients' condition at the end of treatment. The investigator will rate whether the participant's total improvement was due entirely to the intervention. Responses include 0 (not assessed) and range from 1 (very much improved) to 7 (very much worse). | | Posted | | Mean | Standard Deviation | score on a scale | | Change from Mid-treatment at Week 4 to Post-treatment at Week 8 | | | | ID | Title | Description |
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| OG000 | WB001 With Adjunctive Treatment as Usual | Participants randomized to the WB001 + TAU group will be asked to download and use the study application. WB001: WB001 is a digital therapeutic for postpartum depression. | | OG001 | Educational Control (ED001) With Adjunctive Treatment as Usual | Participants randomized to the ED001 + TAU group will be asked to download and use the study application. ED001: ED001 is a digital therapeutic for postpartum depression. |
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| Secondary | Patient Global Impression Scale (PGI) | Measure of change in clinical status. A single item scale based on the CGI and adapted to the patient that mainly measures change in clinical status (PGI-C) but can also measure disease severity (PGI-S) or disease improvement (PGI-I). PGI-S responses for current illness severity range from "I Feel Fine (1)" to "I Feel Extremely Ill (4)". PGI-C responses range from "Very Much Improved (1) to "Very Much Worse (7)" since starting the trial. For both scales, lower scores indicate better outcomes. | | Posted | | Mean | Standard Deviation | score on a scale | | PGI-S: Change from Baseline to Post-treatment at Week 8; PGI-C: Change from Mid-treatment at Week 4 to Post-treatment at Week 8 | | | | ID | Title | Description |
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| OG000 | WB001 With Adjunctive Treatment as Usual | Participants randomized to the WB001 + TAU group will be asked to download and use the study application. WB001: WB001 is a digital therapeutic for postpartum depression. | | OG001 | Educational Control (ED001) With Adjunctive Treatment as Usual | Participants randomized to the ED001 + TAU group will be asked to download and use the study application. ED001: ED001 is a digital therapeutic for postpartum depression. |
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| Secondary | Client Satisfaction Questionnaire (CSQ-8) | An 8-item measure used to assess client's satisfaction with treatment.Total scores range from 8-32, with high scores indicating greater satisfaction with the treatment. | One participant did not complete the CSQ-8 | Posted | | Mean | Standard Deviation | score on a scale | | Post-treatment at Week 8 | | | | ID | Title | Description |
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| OG000 | WB001 With Adjunctive Treatment as Usual | Participants randomized to the WB001 + TAU group will be asked to download and use the study application. WB001: WB001 is a digital therapeutic for postpartum depression. | | OG001 | Educational Control (ED001) With Adjunctive Treatment as Usual | Participants randomized to the ED001 + TAU group will be asked to download and use the study application. ED001: ED001 is a digital therapeutic for postpartum depression. |
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