Prospective Study Evaluating a Novel Mobile App Based Preventive Behavioral Intervention for Perinatal Mood Disorders
Primary Purpose
Perinatal Depression, Perinatal Anxiety
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
App-based "positive intelligence" intervention
Standard of care
Sponsored by
About this trial
This is an interventional prevention trial for Perinatal Depression
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A novel mobile-App based intervention
Standard of Care
Arm 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.
Standard prenatal care and follow up
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Completion of App-based intervention program
Self reported completion of App based 6 weeks training program.
Patient Satisfaction
Patient satisfaction measured by Client Satisfaction Questionnaire scale. scale 8-32, with higher scores indicate greater satisfaction.
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.
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.
Full Information
NCT ID
NCT04914299
First Posted
May 31, 2021
Last Updated
June 5, 2021
Sponsor
Massachusetts General Hospital
Collaborators
Positive Intelligence Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04914299
Brief Title
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Anticipated)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Positive Intelligence Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Depression, Perinatal Anxiety
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A novel mobile-App based intervention
Arm Type
Experimental
Arm 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.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Standard prenatal care and follow up
Intervention Type
Behavioral
Intervention Name(s)
App-based "positive intelligence" intervention
Intervention Description
A 6 weeks App-guided and support-group based "positive intelligence" cognitive behavioral intervention in addition to standard prenatal and postnatal care
Intervention Type
Behavioral
Intervention Name(s)
Standard of care
Intervention Description
Standard prenatal and postnatal care(Providing psychoeducation and referral to psychotherapy or pharmacotherapy based on participant's symptoms).
Primary Outcome Measure Information:
Title
Postpartum Depression Symptoms
Description
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.
Time Frame
3rd trimester pregnancy till 6 months postpartum
Secondary Outcome Measure Information:
Title
Completion of App-based intervention program
Description
Self reported completion of App based 6 weeks training program.
Time Frame
6 weeks postpartum
Title
Patient Satisfaction
Description
Patient satisfaction measured by Client Satisfaction Questionnaire scale. scale 8-32, with higher scores indicate greater satisfaction.
Time Frame
6 weeks postpartum to 6 months postpartum
Title
Generalized Anxiety Symptoms
Description
Anxiety Symptoms measured by Generalized Anxiety Scale. scale 0-21, with with 0 indicating no symptoms, and 21 indicating the highest severity of symptoms.
Time Frame
3rd trimester pregnancy till 6 months postpartum
Title
Patient depression symptoms and severity
Description
Depression Symptoms measured by Patient Health Questionnaire scale. Scale 0-27, with 0 indicating no symptoms, and 27 indicating the highest severity of symptoms.
Time Frame
3rd trimester pregnancy till 6 months postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shay Erisson, MD
Phone
6173322345
Email
serisson@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shay Erisson, MD
Organizational Affiliation
Mass General Brigham
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25932866
Citation
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Results Reference
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29683911
Citation
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Prospective Study Evaluating a Novel Mobile App Based Preventive Behavioral Intervention for Perinatal Mood Disorders
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