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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Positive Intelligence - Prospective Study Evaluating a Novel Mobile App Based Preventive Behavioral Intervention for Perinatal Mood Disorders

Conditions
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Perinatal Depression, Perinatal Anxiety

Intervention / Treatment
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* Behavioral: App-based positive intelligence intervention
* Behavioral: Standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A novel mobile-App based intervention<br>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. | Behavioral: App-based positive intelligence intervention<br>* A 6 weeks App-guided and support-group based positive intelligence cognitive behavioral intervention in addition to standard prenatal and postnatal care<br>Behavioral: Standard of care<br>* Standard prenatal and postnatal care(Providing psychoeducation and referral to psychotherapy or pharmacotherapy based on participant's symptoms).<br>|
| Active Comparator: Standard of Care<br>Standard prenatal care and follow up | Behavioral: Standard of care<br>* Standard prenatal and postnatal care(Providing psychoeducation and referral to psychotherapy or pharmacotherapy based on participant's symptoms).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum Depression Symptoms | Postpartum Depression Symptoms measured by Edinburgh Postnatal Depression Scale postpartum. Scale 1-30,with 0 indicating no symptoms, and 30 indicating the highest severity of symptoms. | 3rd trimester pregnancy till 6 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of App-based intervention program | Self reported completion of App based 6 weeks training program. | 6 weeks postpartum | 
| Patient Satisfaction | Patient satisfaction measured by Client Satisfaction Questionnaire scale. scale 8-32, with higher scores indicate greater satisfaction. | 6 weeks postpartum to 6 months postpartum | 
| Generalized Anxiety Symptoms | Anxiety Symptoms measured by Generalized Anxiety Scale. scale 0-21, with with 0 indicating no symptoms, and 21 indicating the highest severity of symptoms. | 3rd trimester pregnancy till 6 months postpartum | 
| Patient depression symptoms and severity | Depression Symptoms measured by Patient Health Questionnaire scale. Scale 0-27, with 0 indicating no symptoms, and 27 indicating the highest severity of symptoms. | 3rd trimester pregnancy till 6 months postpartum |