Back to results[Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to TAU in Postpartum Depression]
Primary Purpose
Postpartum Depression
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WB001
ED001
Sponsored by
About this trial
This is an interventional treatment trial for Postpartum Depression focused on measuring Postpartum Depression, PPD, Postpartum Depression Treatment, PPD Treatment, Smartphone application, Digital therapeutic
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Woebot Investigational Site
- Woebot Investigational Site
- Woebot Investigational Site
- Woebot Investigational Site
- Woebot Investigational Site
- Woebot Investigational Site
- Woebot Investigational Site
- Woebot Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
WB001 with adjunctive Treatment as Usual
Educational Control (ED001) with adjunctive Treatment as Usual
Arm Description
Participants randomized to the WB001 + TAU group will be asked to download and use the study application.
Participants randomized to the ED001 + TAU group will be asked to download and use the study application.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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.
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.
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).
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).
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).
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.
Full Information
NCT ID
NCT05551195
First Posted
September 19, 2022
Last Updated
July 18, 2023
Sponsor
Woebot Health
Collaborators
Iqvia Pty Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05551195
Brief Title
[Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to TAU in Postpartum Depression]
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Internal company decision
Study Start Date
November 16, 2022 (Actual)
Primary Completion Date
May 10, 2023 (Actual)
Study Completion Date
May 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Woebot Health
Collaborators
Iqvia Pty Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
Postpartum Depression, PPD, Postpartum Depression Treatment, PPD Treatment, Smartphone application, Digital therapeutic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 randomization
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WB001 with adjunctive Treatment as Usual
Arm Type
Other
Arm Description
Participants randomized to the WB001 + TAU group will be asked to download and use the study application.
Arm Title
Educational Control (ED001) with adjunctive Treatment as Usual
Arm Type
Other
Arm Description
Participants randomized to the ED001 + TAU group will be asked to download and use the study application.
Intervention Type
Device
Intervention Name(s)
WB001
Intervention Description
WB001 is a digital therapeutic for postpartum depression.
Intervention Type
Device
Intervention Name(s)
ED001
Intervention Description
ED001 is a digital therapeutic for postpartum depression.
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression (HAM-D)
Description
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.
Time Frame
Change from Baseline to Post-treatment at Week 8
Secondary Outcome Measure Information:
Title
Edinburgh Postpartum Depression Scale (EPDS)
Description
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 Baseline to Post-treatment at Week 8
Title
Patient Health Questionnaire (PHQ-9)
Description
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 Baseline to Post-treatment at Week 8
Title
Generalized Anxiety Disorder Questionnaire (GAD-7)
Description
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 Post-treatment at Week 8
Title
Mother-to-Infant Bonding Scale (MIBS)
Description
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.
Time Frame
Change from Baseline to Post-treatment at Week 8
Title
Clinical Global Impressions Scale - Severity of Illness (CGI-S)
Description
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).
Time Frame
Change Baseline to Post-treatment at Week 8
Title
Clinical Global Impressions Scale - Global Improvement (CGI-I)
Description
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).
Time Frame
Change from Mid-treatment at Week 4 to Post-treatment at Week 8
Title
Patient Global Impression Scale (PGI)
Description
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).
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
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
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.
Time Frame
Post-treatment at Week 8
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Facility Information:
Facility Name
Woebot Investigational Site
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Facility Name
Woebot Investigational Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
Country
United States
Facility Name
Woebot Investigational Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Woebot Investigational Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Woebot Investigational Site
City
Seminole
State/Province
Florida
ZIP/Postal Code
33777
Country
United States
Facility Name
Woebot Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Woebot Investigational Site
City
Glen Oaks
State/Province
New York
ZIP/Postal Code
11004
Country
United States
Facility Name
Woebot Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
12. IPD Sharing Statement
Learn more about this trial
[Study Evaluating the Efficacy and Safety of a Digital Therapeutic as an Adjunct to TAU in Postpartum Depression]
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