Prospective Study Evaluating a Novel Mobile App Based Preventive Behavioral Intervention for Perinatal Mood Disorders

Mass General Brigham

Status: Withdrawn

Conditions: Perinatal Depression; Perinatal Anxiety

Treatments: Behavioral: Standard of care; Behavioral: App-based "positive intelligence" intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04914299

2021P001387

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

A novel mobile-App based intervention

Experimental group

Description:

An App-based "positive intelligence" intervention consisting of 6 weeks of weekly videos and support group sessions, and 6 weeks of daily App-guided practices.

Treatment:

Behavioral: App-based "positive intelligence" intervention

Behavioral: Standard of care

Standard of Care

Active Comparator group

Description:

Standard prenatal care and follow up

Treatment:

Behavioral: Standard of care