Postpartum DepressionNCT05551195
[Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to TAU in Postpartum Depression]
A study testing WB001 and ED001 in people with Postpartum Depression, run by Woebot Health at 8 sites in United States.
Trial summary
This study evaluates the efficacy of two digital therapeutics, WB001 and ED001, on depressive symptoms among women diagnosed with postpartum depression. Read more about this study
- Who is it for?
- Ages 22 to 45 years, women only
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- WB001 and ED001
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 8 sitesUnited States
- Study dates
- 16 Nov 2022to 10 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Must have primary residence in the United States
- Must be ≤ 92 days postpartum
- Must be women aged 22-45 years who had onset of a major depressive episode any time during pregnancy or within 4 weeks following delivery
- Must own or have regular access to a smartphone (Android or iOS smartphone with a recent, supported operating system), and has reliable Wi-Fi access or sufficient data plan to engage with assigned treatment condition for the duration of the study
- Participants must have current mild-moderate depression as measured by the HAMD-6 score >7 and <13 at screening
- Participant must have a form of TAU, defined as clinician supervised outpatient care management and includes follow-up visits, medication, psychotherapy, or some combination thereof
- TAU must be regularly scheduled or stable for at least 4 weeks prior to baseline (BL) visit
Who cannot join
- Gestation less than 28 weeks
- HAMD-6 score ≤7 or ≥13 (severe depression) at screening
- Currently pregnant or plans to become pregnant within the next 8 weeks
- History of drug and/or alcohol use disorder within the past 12 months
- Lifetime history of suicide attempt or ideation with a plan and intent to harm oneself during the current episode of PPD
- Current or lifetime psychosis
Show all 10Show fewer
- Current or lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, and/or homicidal or infanticidal ideation
- History of antidepressant treatment with ketamine/esketamine, electroconvulsive therapy, vagal nerve stimulation, or a deep brain stimulation device
- History of treatment-resistant depression (TRD)
- Fetal demise within the past 18 months
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Woebot Investigational Site
Cleveland, Ohio, 44122
Woebot Investigational Site
Decatur, Georgia, 30033
Woebot Investigational Site
DeLand, Florida, 32720
Woebot Investigational Site
Glen Oaks, New York, 11004
Woebot Investigational Site
Lafayette, California, 94549
Woebot Investigational Site
Miami Lakes, Florida, 33016
Woebot Investigational Site
Santa Ana, California, 92704
Woebot Investigational Site
Seminole, Florida, 33777
About this study
Official title: A Multicenter, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to Treatment as Usual Among Women With Mild to Moderate Postpartum Depression
This study evaluates the efficacy of two digital therapeutics, WB001 and ED001, on depressive symptoms among women diagnosed with postpartum depression.
Read the detailed description
This randomized, double-blind, controlled trial evaluates the efficacy and safety of 8 weeks of treatment of two digital therapeutics in a population of women with mild to moderate postpartum depression. Patients will be referred by an obstetrician, pediatrician, or other healthcare professional, or by other digital and site based recruitment methods and, if interested, will complete the pre-screening process. Those confirmed as eligible will be scheduled to attend a screening/baseline onsite visit. Eligible participants will be randomized to one of the two groups and will receive instructions on downloading and using the smartphone application to which they were randomized. Participants will use the app as instructed and will attend telehealth visits to complete assessments for the primary and safety endpoints at Weeks 4 and 8 (EOT).
- Conditions
- Postpartum Depression
- Being tested
- WB001, ED001
- Keywords
- Postpartum Depression, PPD, Postpartum Depression Treatment, PPD Treatment, Smartphone application, Digital therapeutic
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WB001Device
WB001 is a digital therapeutic for postpartum depression.
ED001Device
ED001 is a digital therapeutic for postpartum depression.
| Study group | Role | What they receive |
|---|---|---|
| WB001 with adjunctive Treatment as Usual | Other | Participants randomized to the WB001 + TAU group will be asked to download and use the study application. Receives: Device: WB001 |
| Educational Control (ED001) with adjunctive Treatment as Usual | Other | Participants randomized to the ED001 + TAU group will be asked to download and use the study application. Receives: Device: ED001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression (HAM-D)
Measure of depression. This is a 6-item questionnaire, where total scores range from 0 to 22, with higher scores indicating greater severity of depression.
Measured: Change from Baseline to Post-treatment at Week 8
Secondary outcomes (8)
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.
Measured: Change Baseline to Post-treatment at 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
Measured: Change Baseline to Post-treatment at Week 8
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.
Measured: Change from Baseline to Post-treatment at Week 8
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.
Measured: Change from Baseline to Post-treatment at Week 8
Clinical Global Impressions Scale - Severity of Illness (CGI-S)
Measure of overall severity of current clinical presentation and symptomatology. A single item, 7-point Likert scale on which the investigator will rate patients' severity of illness based on clinical interviews and assessments relative to their experience with other patients with the same diagnosis. Responses include 0 (not assessed) and range from 1 (Normal, not at all ill) to 7 (Among the most extremely ill).
Measured: Change Baseline to Post-treatment at Week 8
Clinical Global Impressions Scale - Global Improvement (CGI-I)
Measure of improvement. A single item, 7-point Likert scale that assesses the overall improvement in patients' condition at the end of treatment. The investigator will rate whether the participant's total improvement was due entirely to the intervention. Responses include 0 (not assessed) and range from 1 (very much improved) to 7 (very much worse).
Measured: Change from Mid-treatment at Week 4 to Post-treatment at Week 8
Patient Global Impression Scale (PGI)
Measure of change in clinical status. A single item scale based on the CGI and adapted to the patient that mainly measures change in clinical status (PGI-C) but can also measure disease severity (PGI-S) or disease improvement (PGI-I). PGI-S responses for current illness severity range from "I Feel Fine (1)" to "I Feel Extremely Ill (4)". PGI-C responses range from "Very Much Improved (1) to "Very Much Worse (7)" since starting the trial. For both scales, lower scores indicate better outcomes.
Measured: PGI-S: Change from Baseline to Post-treatment at Week 8; PGI-C: Change from Mid-treatment at Week 4 to Post-treatment at Week 8
Client Satisfaction Questionnaire (CSQ-8)
An 8-item measure used to assess client's satisfaction with treatment.Total scores range from 8-32, with high scores indicating greater satisfaction with the treatment.
Measured: Post-treatment at Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start16 Nov 2022
- Primary completion10 May 2023
- Study completion10 May 2023
Why it stopped: Internal company decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postpartum DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woebot Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551195
- Sponsor's protocol ID
- WB001-001
- Status last verified
- Jan 2025
- First submitted
- 19 Sep 2022
- Last updated
- 24 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to Treatment as Usual Among Women With Mild to Moderate Postpartum Depression
- ClinicalTrials.gov ID
- NCT05551195
- Acronym / sponsor ID
- WB001-001
- Conditions
- Postpartum Depression
- Keywords
- Postpartum Depression, PPD, Postpartum Depression Treatment, PPD Treatment, Smartphone application, Digital therapeutic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Internal company decision
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Woebot HealthIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 10 May 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 22 Sep 2022 (actual)
- Results
- Posted 24 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the efficacy of two digital therapeutics, WB001 and ED001, on depressive symptoms among women diagnosed with postpartum depression.
Detailed description
This randomized, double-blind, controlled trial evaluates the efficacy and safety of 8 weeks of treatment of two digital therapeutics in a population of women with mild to moderate postpartum depression. Patients will be referred by an obstetrician, pediatrician, or other healthcare professional, or by other digital and site based recruitment methods and, if interested, will complete the pre-screening process. Those confirmed as eligible will be scheduled to attend a screening/baseline onsite visit. Eligible participants will be randomized to one of the two groups and will receive instructions on downloading and using the smartphone application to which they were randomized. Participants will use the app as instructed and will attend telehealth visits to complete assessments for the primary and safety endpoints at Weeks 4 and 8 (EOT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| WB001 with adjunctive Treatment as Usual | Other | Device: WB001Participants randomized to the WB001 + TAU group will be asked to download and use the study application. |
| Educational Control (ED001) with adjunctive Treatment as Usual | Other | Device: ED001Participants randomized to the ED001 + TAU group will be asked to download and use the study application. |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Must have primary residence in the United States
- Must be ≤ 92 days postpartum
- Must be women aged 22-45 years who had onset of a major depressive episode any time during pregnancy or within 4 weeks following delivery
- Must own or have regular access to a smartphone (Android or iOS smartphone with a recent, supported operating system), and has reliable Wi-Fi access or sufficient data plan to engage with assigned treatment condition for the duration of the study
- Participants must have current mild-moderate depression as measured by the HAMD-6 score >7 and <13 at screening
Key exclusion criteria (10 listed)
- Gestation less than 28 weeks
- HAMD-6 score ≤7 or ≥13 (severe depression) at screening
- Currently pregnant or plans to become pregnant within the next 8 weeks
- History of drug and/or alcohol use disorder within the past 12 months
- Lifetime history of suicide attempt or ideation with a plan and intent to harm oneself during the current episode of PPD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WB001WB001 is a digital therapeutic for postpartum depression. | Device | WB001 with adjunctive Treatment as Usual |
| ED001ED001 is a digital therapeutic for postpartum depression. | Device | Educational Control (ED001) with adjunctive Treatment as Usual |
Primary outcome
Hamilton Rating Scale for Depression (HAM-D)
Time frame: Change from Baseline to Post-treatment at Week 8
Measure of depression. This is a 6-item questionnaire, where total scores range from 0 to 22, with higher scores indicating greater severity of depression.
8 secondary outcomes
Edinburgh Postpartum Depression Scale (EPDS)
Time frame: Change Baseline to Post-treatment at Week 8
Patient Health Questionnaire (PHQ-9)
Time frame: Change Baseline to Post-treatment at Week 8
Generalized Anxiety Disorder Questionnaire (GAD-7)
Time frame: Change from Baseline to Post-treatment at Week 8
Mother-to-Infant Bonding Scale (MIBS)
Time frame: Change from Baseline to Post-treatment at Week 8
Clinical Global Impressions Scale - Severity of Illness (CGI-S)
Time frame: Change Baseline to Post-treatment at Week 8
Clinical Global Impressions Scale - Global Improvement (CGI-I)
Time frame: Change from Mid-treatment at Week 4 to Post-treatment at Week 8
Patient Global Impression Scale (PGI)
Time frame: PGI-S: Change from Baseline to Post-treatment at Week 8; PGI-C: Change from Mid-treatment at Week 4 to Post-treatment at Week 8
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Post-treatment at Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WB001 and ED001 in people with Postpartum Depression, run by Woebot Health at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Rating Scale for Depression (HAM-D) (time frame: Change from Baseline to Post-treatment at Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.