A Six-Month Prospective Follow-Up Study of WB001

NCT ID: NCT05693792

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2024-06-08

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postpartum Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Observational

Intervention Type OTHER

No treatment regimen will be deployed in this follow-up study.

Interventions

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Observational

No treatment regimen will be deployed in this follow-up study.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Woebot Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Related Links

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https://clinicaltrials.gov/ct2/show/NCT05551195

\[Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to TAU in Postpartum Depression\]

Other Identifiers

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WB001-002

Identifier Type: -

Identifier Source: org_study_id

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