Mobile Application in the Management of Mild to Moderate... | NCT05077644

Studies
Mobile Application in the Management of Mild to Moderate Postpartum Depression (PPD)

NCT05077644

Sponsor

Curio Digital Therapeutics, Inc.

Status

Unknown status

Last Update Posted

Oct 14, 2021Actual

Enrollment

65Estimated

Phase

Not Applicable

Conditions

Post-partum Depression

Interventions

Stella (TM) Mobile Application

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2021Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Oct 1, 2021

First Submission Date that Met QC Criteria

Oct 1, 2021

First Posted Date

Oct 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2021

Last Update Posted Date

Oct 14, 2021Actual

Description Module

Brief 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.

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants who use Stella App	Other	Participant experience in using the mobile application and EPDS results	Device: Stella (TM) Mobile Application

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stella (TM) Mobile Application	Device	Treatment of mild-to-moderate postpartum depression (PPD) using Cognitive Behavioral Therapy techniques.	Participants who use Stella App

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	8 week period

Secondary Outcomes

Measure	Description	Time Frame
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	8 week period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Adult females who delivered live births in the 4 months prior to study start and reported depressive symptoms after child birth

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eliza Ng, MPH, MD	Contact	1-800-762-9854		Eliza@Curiodigitaltx.com
Melva Covington, MPH, PhD	Contact	1-800-762-9854		Melva@Curiodigitaltx.com

Overall Officials

Name	Affiliation	Role
Stan Kachnowski, MPA, PhD	Healthcare Innovation Technology Lab	Principal Investigator
Sarah Chokshi, DrPH	Healthcare Innovation Technology Lab	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HITLAB	Recruiting	New York	New York	10014	United States

ID	Term
D019052	Depression, Postpartum
D003863	Depression
D001008	Anxiety Disorders

ID	Term
D011644	Puerperal Disorders
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Intervention 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