A Six-Month Prospective Follow-Up Study of WB001

Woebot Health

Status: Withdrawn

Conditions: Postpartum Depression

Treatments: Other: Observational

Study type: Observational

Funder types: Industry

Identifiers

NCT05693792

WB001-002

Details and patient eligibility

About

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.

Full description

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.

Sex: Female

Ages: 22 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Must have prior enrollment in the WB001-001 trial and completion of Week 8/EOT
2. Must be willing and able to comply with all study procedures

Exclusion criteria

1. Documented AE or SAE at WB001-001 Week 8 related to participant safety, by Investigator judgement

Trial design

0 participants in 1 patient group

Follow-up Group

Description:

Participants randomized to {WB001+TAU} and {ED001+TAU} in the parent study (WB001-001) will be assessed for 6 months following treatment completion.

Treatment:

Other: Observational