Clinical trial NCT05077644: Mobile Application in the Management of Mild to Moderate Postpartum Depression (PPD)
Official title: Mobile Application in the Management of Mild to Moderate Postpartum Depression (PPD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-partum Depression
Keywords: post-partum depression, depression, anxiety, PPD
Lead sponsor: Curio Digital Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-14
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

1. 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
2. Participants must be between 18 and 50 years of age
3. Participants must have given live birth within the 4 months prior to the start of study
4. 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
5. Participants must answer "0/Never" or "1/Hardly Ever" to the self-harm question on EPDS (Question #10)
6. Participants must be willing to use a mobile app and own an iOS enabled mobile phone
7. Participants must have wireless internet connectivity in the home and be willing to connect devices to their home Wi-Fi network.

Exclusion Criteria:

1. Participants who do not reside in the states of New York, New Jersey or Connecticut
2. Participants who are not able to read, write, and speak English, and provide written informed consent prior to enrollment
3. Participants less than 18 and more than 50 years of age
4. 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
5. 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
6. Participants with a positive (2 or 3) answer on the EPDS self-harm question (Question #10)
7. Participants with Serious Mental Illnesses (SMIs), severe depression, or cognitive impairments

Primary outcomes:
measure: Change in level of depression as measured by Edinburgh Postpartum Depression (EPDS)
timeFrame: 8 week period
Secondary outcomes:
measure: Proportion of women who reported App use for daily mood, sleep and activities of daily living
timeFrame: 8 week period
Other outcomes:
Locations:
city: New York
country: United States
facility: HITLAB
state: New York
Study officials:
affiliation: Healthcare Innovation Technology Lab
name: Stan Kachnowski, MPA, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Healthcare Innovation Technology Lab
name: Sarah Chokshi, DrPH
role: STUDY_DIRECTOR
References: