A Six-Month Prospective Follow-Up Study of WB001

NCT05693792 | Withdrawn FDA Device

• 1 other identifier: WB001-002
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postpartum Depression

Keywords

Postpartum Depression

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Patient Health Questionnaire (PHQ-9)

  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)

  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)

  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)

  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)

  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

Study Arms (1)

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.

Other: Observational

Interventions

Observational OTHER

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

Follow-up Group

Eligibility Criteria

• Age: 22 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Woebot Health: lead

Related Links

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

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 23, 2023
• Study Start: February 1, 2023
• Primary Completion: June 8, 2024
• Study Completion: June 8, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-05