Clinical trial NCT04914299: Prospective Study Evaluating a Novel Mobile App Based Preventive Behavioral Intervention for Perinatal Mood Disorders
Official title: Positive Intelligence - Prospective Study Evaluating a Novel Mobile App Based Preventive Behavioral Intervention for Perinatal Mood Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Perinatal Depression
Perinatal Anxiety
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Positive Intelligence Inc.
First posted: 2021-06-04
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: One receives a novel mobile-App based intervention and the other groups receives standard of care (psychoeducation about postpartum depression, referral and monitoring).
Primary purpose: PREVENTION

Brief summary: The primary aim of the study is to investigate whether a novel mobile App-based behavioral intervention in pregnant women can: (1) prevent and/or decrease the incidence of perinatal mood disorders (2) decrease the severity and/or duration of perinatal mood disorders in affected participants (3) increase access of pregnant women to behavioral intervention and support tools (4) increase the satisfaction of pregnant women with their prenatal care.

Detailed description: Perinatal depression is an episode of major or minor depression that occurs during pregnancy or in the 12 months after birth; it affects about 10% of new mothers. Postpartum depression accounts for 12.5% of psychologically related hospitalizations among women.

In 2019, the United States Preventive Services Task Force (USPSTF) recommended screening pregnant women to identify those at risk for perinatal depression and refer them for counseling. The USPSTF recommendation is based on growing literature indicating that counseling women at risk for perinatal depression reduce the risk of having an episode of major depression by 40%.

Supporting that, multiple studies have shown that cognitive-behavioral intervention and mental health care adjuvant therapy can effectively improve the condition of patients with postpartum depression. Finally, access to care has also been shown to be an important factor in determining the success of any intervention. Women across high and low-risk groups often have barriers to treatment due to stigma, shame, and fear to disclose symptoms to health providers

In this research, the investigators aim to investigate whether a novel mobile App-based behavioral intervention can meaningfully increase access and demonstrate a beneficial effect in preventing anxiety and depression in the postpartum period. Furthermore and adding to the existing literature in post-partum depression, this study aims to investigate the role of "positive intelligence", an integrative positive cognitive behavioral therapy, as a tool in the prevention and treatment of perinatal mood disorders.

Eligibility criteria: Inclusion Criteria:

* Able to read and speak English
* Have a low-risk singleton pregnancy with more than 24 weeks of gestation
* Have smartphone with internet access
* Failure to meet criteria for a diagnosis of MDD in the last two months

Exclusion Criteria:

* Physical or mental disorders which would interfere with their ability to participate in the study
* High-risk pregnancy
* Give birth to a newborn at still-birth or a newborn with congenital anomalies and/or Medical complications that require special care in hospital
* Infant has a birth weight lower than 2,500 grams
* Infant has a 5-minute Apgar score lower than 7

Primary outcomes:
measure: Postpartum Depression Symptoms
timeFrame: 3rd trimester pregnancy till 6 months postpartum
Secondary outcomes:
measure: Completion of App-based intervention program
timeFrame: 6 weeks postpartum
measure: Patient Satisfaction
timeFrame: 6 weeks postpartum to 6 months postpartum
measure: Generalized Anxiety Symptoms
timeFrame: 3rd trimester pregnancy till 6 months postpartum
measure: Patient depression symptoms and severity
timeFrame: 3rd trimester pregnancy till 6 months postpartum
Other outcomes:
Locations:
Study officials:
affiliation: Mass General Brigham
name: Shay Erisson, MD
role: PRINCIPAL_INVESTIGATOR
References:
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