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.
Study Type
OBSERVATIONAL
No treatment regimen will be deployed in this follow-up study.
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.
Time frame: Change from Baseline to Week 4; Change from Baseline to Week 8
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.
Time frame: 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
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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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