Post-partum DepressionNCT05077644
Mobile Application in the Management of Mild to Moderate Postpartum Depression (PPD)
A study testing Stella (TM) Mobile Application in people with Post-partum Depression, run by Curio Digital Therapeutics, Inc. at 1 site in United States.
Trial summary
Primary Objective: Evaluate the user experience with the Stella (TM) app for the management of Postpartum Depression in an observed population for 8 calendar weeks. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-partum Depression
- What is being tested?
- Stella (TM) Mobile Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants residing in the states of New York, New Jersey or Connecticut and must be able to read, write, and speak English, and provide written informed consent prior to enrollment
- Participants must be between 18 and 50 years of age
- Participants must have given live birth within the 4 months prior to the start of study
- Participants diagnosed with mild to moderate postpartum depression (as assessed by a clinician upon enrollment) and have scored between 9 and 21 on the Edinburgh Postnatal Depression Scale (EPDS) during screening
- Participants must answer "0/Never" or "1/Hardly Ever" to the self-harm question on EPDS (Question #10)
- Participants must be willing to use a mobile app and own an iOS enabled mobile phone
- Participants must have wireless internet connectivity in the home and be willing to connect devices to their home Wi-Fi network.
Who cannot join
- Participants who do not reside in the states of New York, New Jersey or Connecticut
- Participants who are not able to read, write, and speak English, and provide written informed consent prior to enrollment
- Participants less than 18 and more than 50 years of age
- Participants who have not given birth within the 4 months prior to the start of study OR did not have a live birth in the last 4 months
- Participants who have not been diagnosed with postpartum depression upon clinical assessment OR do not have a score of between 9 and 21 on the EPDS
- Participants with a positive (2 or 3) answer on the EPDS self-harm question (Question #10)
- Participants with Serious Mental Illnesses (SMIs), severe depression, or cognitive impairments
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
HITLAB
New York, New York, 10014
Kat Marriott, PhD, 929-502-7147, kmarriott@hitlab.org
About this study
Primary Objective: Evaluate the user experience with the Stella (TM) app for the management of Postpartum Depression in an observed population for 8 calendar weeks.
Read the detailed description
Women between 18 and 50 years of age who have had a live birth within 4 months prior to study start date and have a diagnosis of mild to moderate PPD. A total of 65 women residing in the state of New York, New Jersey and Connecticut will be recruited to participate in the study. Patient reported outcomes of mild to moderate depression (using EPDS) will be verified by a behavioral health therapist using the Hamilton Depression Rating Scale (HAM-D).
- Conditions
- Post-partum Depression
- Being tested
- Stella (TM) Mobile Application
- Keywords
- post-partum depression, depression, anxiety, PPD
- Medical subject headings
- Depression, Postpartum, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stella (TM) Mobile ApplicationDevice
Treatment of mild-to-moderate postpartum depression (PPD) using Cognitive Behavioral Therapy techniques.
| Study group | Role | What they receive |
|---|---|---|
| Participants who use Stella App | Other | Participant experience in using the mobile application and EPDS results Receives: Device: Stella (TM) Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of depression as measured by Edinburgh Postpartum Depression (EPDS)
Evaluation of difference in mean change in EDPS at week 8 from baseline assessment. EPDS evaluated every 2 weeks from baseline to week 8
Measured: 8 week period
Secondary outcomes (1)
Proportion of women who reported App use for daily mood, sleep and activities of daily living
Summary reported of daily mood, hours of sleep and activities of daily living as identified through the mobile application
Measured: 8 week period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start1 Oct 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-partum 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
- Not applicable
- Intervention model
- Single group
- Model description
- Data from 65 participants (n=50 in this extended study of a piloted user study) will be collected and analyzed to assess the user experience of the Stella (TM) App. Participants will be selected if they have given birth in the four months prior to the study start date, meet eligibility criteria and and have mild-to moderate postpartum depression or have experienced depressive
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Curio Digital Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stan Kachnowski, MPA, PhD, Principal investigator, Healthcare Innovation Technology LabSarah Chokshi, DrPH, Study director, Healthcare Innovation Technology Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077644
- Sponsor's protocol ID
- CU-T-002
- Status last verified
- Oct 2021
- First submitted
- 1 Oct 2021
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Application in the Management of Mild to Moderate Postpartum Depression (PPD)
- ClinicalTrials.gov ID
- NCT05077644
- Acronym / sponsor ID
- CU-T-002
- Conditions
- Post-partum Depression
- Keywords
- post-partum depression, depression, anxiety, PPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Curio Digital Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective: Evaluate the user experience with the Stella (TM) app for the management of Postpartum Depression in an observed population for 8 calendar weeks.
Detailed description
Women between 18 and 50 years of age who have had a live birth within 4 months prior to study start date and have a diagnosis of mild to moderate PPD. A total of 65 women residing in the state of New York, New Jersey and Connecticut will be recruited to participate in the study. Patient reported outcomes of mild to moderate depression (using EPDS) will be verified by a behavioral health therapist using the Hamilton Depression Rating Scale (HAM-D).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Data from 65 participants (n=50 in this extended study of a piloted user study) will be collected and analyzed to assess the user experience of the Stella (TM) App. Participants will be selected if they have given birth in the four months prior to the study start date, meet eligibility criteria and and have mild-to moderate postpartum depression or have experienced depressive
| Arm | Type | Receives |
|---|---|---|
| Participants who use Stella App | Other | Device: Stella (TM) Mobile ApplicationParticipant experience in using the mobile application and EPDS results |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants residing in the states of New York, New Jersey or Connecticut and must be able to read, write, and speak English, and provide written informed consent prior to enrollment
- Participants must be between 18 and 50 years of age
- Participants must have given live birth within the 4 months prior to the start of study
- Participants diagnosed with mild to moderate postpartum depression (as assessed by a clinician upon enrollment) and have scored between 9 and 21 on the Edinburgh Postnatal Depression Scale (EPDS) during screening
- Participants must answer "0/Never" or "1/Hardly Ever" to the self-harm question on EPDS (Question #10)
Key exclusion criteria (7 listed)
- Participants who do not reside in the states of New York, New Jersey or Connecticut
- Participants who are not able to read, write, and speak English, and provide written informed consent prior to enrollment
- Participants less than 18 and more than 50 years of age
- Participants who have not given birth within the 4 months prior to the start of study OR did not have a live birth in the last 4 months
- Participants who have not been diagnosed with postpartum depression upon clinical assessment OR do not have a score of between 9 and 21 on the EPDS
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 |
|---|---|---|
| Stella (TM) Mobile ApplicationTreatment of mild-to-moderate postpartum depression (PPD) using Cognitive Behavioral Therapy techniques. | Device | Participants who use Stella App |
Primary outcome
Change in level of depression as measured by Edinburgh Postpartum Depression (EPDS)
Time frame: 8 week period
Evaluation of difference in mean change in EDPS at week 8 from baseline assessment. EPDS evaluated every 2 weeks from baseline to week 8
1 secondary outcome
Proportion of women who reported App use for daily mood, sleep and activities of daily living
Time frame: 8 week period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Stan Kachnowski, MPA, PhD principal investigator
Healthcare Innovation Technology Lab
Sarah Chokshi, DrPH study director
Healthcare Innovation Technology Lab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stella (TM) Mobile Application in people with Post-partum Depression, run by Curio Digital Therapeutics, Inc. at 1 site 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 7 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: status not confirmed, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eliza Ng, MPH, MD (1-800-762-9854, Eliza@Curiodigitaltx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in level of depression as measured by Edinburgh Postpartum Depression (EPDS) (time frame: 8 week period). 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 14 Oct 2021.