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Internal company decision
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This study is a 6-month follow-up study to WB001-001 conducted to assess and evaluate the durability of the effect of {WB001+TAU} beyond the 8-week treatment period.
This study is a 6-month prospective, observational follow-up study to the WB001-001 trial. Participants will be a convenience sample of those enrolled in the WB001-001 parent trial who consent to participate in a follow-up study at baseline for WB001-001. After completion of WB001-001's EOT assessment, those consenting to participate in the current study will be screened to confirm eligibility. Eligible participants will complete six assessment batteries (patient-reported outcomes [PROs]) on a monthly basis for a 6-month observation period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Follow-up Group | Participants randomized to {WB001+TAU} and {ED001+TAU} in the parent study (WB001-001) will be assessed for 6 months following treatment completion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other | No treatment regimen will be deployed in this follow-up study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Rating Scale for Depression (HAM-D) | Clinician-rated measure of depression. The HAM-D6 is a subset of the HAM-D17 that assesses the 6 core items associated with major depression. Scores range from 0-22, where higher scores indicate greater depression severity. | Change from Baseline to Week 4; Change from Baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from Baseline to Week 4; Change from Baseline to Week 8; Change from Baseline to Week 12; Change from Baseline to Week 16; Change from Baseline to Week 20; Change from Baseline to Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
1. Documented AE or SAE at WB001-001 Week 8 related to participant safety, by Investigator judgement
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Participants in the current study will be a convenience sample of those enrolled in the WB001-001 parent trial who consent to participate in a follow-up study at baseline for WB001-001.
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| Label | URL |
|---|---|
| \[Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to TAU in Postpartum Depression\] | View source |
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| 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. | Change from Baseline to Week 4; Change from Baseline to Week 8; Change from Baseline to Week 12; Change from Baseline to Week 16; Change from Baseline to Week 20; Change from Baseline to Week 24 |
| 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. | Change from Baseline to Week 4; Change from Baseline to Week 8; Change from Baseline to Week 12; Change from Baseline to Week 16; Change from Baseline to Week 20; Change from Baseline to Week 24 |
| 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. | Change from Baseline to Week 4; Change from Baseline to Week 8; Change from Baseline to Week 12; Change from Baseline to Week 16; Change from Baseline to Week 20; Change from Baseline to Week 24 |
| Patient Global Impression scale (PGI) | Measure of disease severity. A single-item scale asking respondents to rate the severity of their disease. | Change from Baseline to Week 4; Change from Baseline to Week 8; Change from Baseline to Week 12; Change from Baseline to Week 16; Change from Baseline to Week 20; Change from Baseline to Week 24 |
| Columbia-Suicide Severity Rating Scale (C-SSRS) | Measure of risk for suicide. A clinician-administered assessment that measures four constructs: the severity of ideation, the intensity of ideation, behavior, and lethality. The C-SSRS consists of 10 categories with binary responses (Yes or No) to indicate the presence or absence of the behavior with a numerical score outcome. | Change from Baseline to Week 4; Change from Baseline to Week 8; Change from Baseline to Week 12; Change from Baseline to Week 16; Change from Baseline to Week 20; Change from Baseline to Week 24 |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |