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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
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Perinatal Depression

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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

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

    First Posted
    May 31, 2021
    Last Updated
    June 5, 2021
    Sponsor
    Massachusetts General Hospital
    Collaborators
    Positive Intelligence Inc.
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    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
    The American College of Obstetricians and Gynecologists Committee Opinion no. 630. Screening for perinatal depression. Obstet Gynecol. 2015 May;125(5):1268-1271. doi: 10.1097/01.AOG.0000465192.34779.dc.
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    30629567
    Citation
    ACOG Committee Opinion No. 757: Screening for Perinatal Depression. Obstet Gynecol. 2018 Nov;132(5):e208-e212. doi: 10.1097/AOG.0000000000002927.
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    PubMed Identifier
    29683911
    Citation
    ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.
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    Citation
    US Preventive Services Task Force; Curry SJ, Krist AH, Owens DK, Barry MJ, Caughey AB, Davidson KW, Doubeni CA, Epling JW Jr, Grossman DC, Kemper AR, Kubik M, Landefeld CS, Mangione CM, Silverstein M, Simon MA, Tseng CW, Wong JB. Interventions to Prevent Perinatal Depression: US Preventive Services Task Force Recommendation Statement. JAMA. 2019 Feb 12;321(6):580-587. doi: 10.1001/jama.2019.0007.
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