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

NCT04914299 | Withdrawn

• 1 other identifier: 2021P001387
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Perinatal Depression; Perinatal Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Completion of App-based intervention program

  6 weeks postpartum

• Patient Satisfaction

  6 weeks postpartum to 6 months postpartum

• Generalized Anxiety Symptoms

  3rd trimester pregnancy till 6 months postpartum

• Patient depression symptoms and severity

  3rd trimester pregnancy till 6 months postpartum

Study Arms (2)

A novel mobile-App based intervention

EXPERIMENTAL

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; Behavioral: Standard of care

Standard of Care

ACTIVE COMPARATOR

Standard prenatal care and follow up

Behavioral: Standard of care

Interventions

App-based "positive intelligence" intervention BEHAVIORAL

A 6 weeks App-guided and support-group based "positive intelligence" cognitive behavioral intervention in addition to standard prenatal and postnatal care

A novel mobile-App based intervention

Standard of care BEHAVIORAL

Standard prenatal and postnatal care(Providing psychoeducation and referral to psychotherapy or pharmacotherapy based on participant's symptoms).

A novel mobile-App based intervention; Standard of Care

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Positive Intelligence Inc.: collaborator

Related Publications (19)

• 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.

  PMID: 25932866 BACKGROUND

• ACOG Committee Opinion No. 757: Screening for Perinatal Depression. Obstet Gynecol. 2018 Nov;132(5):e208-e212. doi: 10.1097/AOG.0000000000002927.

  PMID: 30629567 BACKGROUND

• ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.

  PMID: 29683911 BACKGROUND

• Morrell CJ, Sutcliffe P, Booth A, Stevens J, Scope A, Stevenson M, Harvey R, Bessey A, Cantrell A, Dennis CL, Ren S, Ragonesi M, Barkham M, Churchill D, Henshaw C, Newstead J, Slade P, Spiby H, Stewart-Brown S. A systematic review, evidence synthesis and meta-analysis of quantitative and qualitative studies evaluating the clinical effectiveness, the cost-effectiveness, safety and acceptability of interventions to prevent postnatal depression. Health Technol Assess. 2016 May;20(37):1-414. doi: 10.3310/hta20370.

  PMID: 27184772 BACKGROUND

• 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.

  PMID: 30747971 BACKGROUND

• Zlotnick C, Johnson SL, Miller IW, Pearlstein T, Howard M. Postpartum depression in women receiving public assistance: pilot study of an interpersonal-therapy-oriented group intervention. Am J Psychiatry. 2001 Apr;158(4):638-40. doi: 10.1176/appi.ajp.158.4.638.

  PMID: 11282702 BACKGROUND

• Zlotnick C, Miller IW, Pearlstein T, Howard M, Sweeney P. A preventive intervention for pregnant women on public assistance at risk for postpartum depression. Am J Psychiatry. 2006 Aug;163(8):1443-5. doi: 10.1176/ajp.2006.163.8.1443.

  PMID: 16877662 BACKGROUND

• McFarlane E, Burrell L, Duggan A, Tandon D. Outcomes of a Randomized Trial of a Cognitive Behavioral Enhancement to Address Maternal Distress in Home Visited Mothers. Matern Child Health J. 2017 Mar;21(3):475-484. doi: 10.1007/s10995-016-2125-7.

  PMID: 27535131 BACKGROUND

• Pessagno RA, Hunker D. Using short-term group psychotherapy as an evidence-based intervention for first-time mothers at risk for postpartum depression. Perspect Psychiatr Care. 2013 Jul;49(3):202-9. doi: 10.1111/j.1744-6163.2012.00350.x. Epub 2012 Aug 17.

  PMID: 23819670 BACKGROUND

• O'Connor E, Senger CA, Henninger ML, Coppola E, Gaynes BN. Interventions to Prevent Perinatal Depression: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2019 Feb 12;321(6):588-601. doi: 10.1001/jama.2018.20865.

  PMID: 30747970 BACKGROUND

• Liu H, Yang Y. Effects of a psychological nursing intervention on prevention of anxiety and depression in the postpartum period: a randomized controlled trial. Ann Gen Psychiatry. 2021 Jan 4;20(1):2. doi: 10.1186/s12991-020-00320-4.

  PMID: 33397393 BACKGROUND

• Avalos LA, Raine-Bennett T, Chen H, Adams AS, Flanagan T. Improved Perinatal Depression Screening, Treatment, and Outcomes With a Universal Obstetric Program. Obstet Gynecol. 2016 May;127(5):917-925. doi: 10.1097/AOG.0000000000001403.

  PMID: 27054938 BACKGROUND

• Byatt N, Simas TA, Lundquist RS, Johnson JV, Ziedonis DM. Strategies for improving perinatal depression treatment in North American outpatient obstetric settings. J Psychosom Obstet Gynaecol. 2012 Dec;33(4):143-61. doi: 10.3109/0167482X.2012.728649.

  PMID: 23194018 BACKGROUND

• Sockol LE. A systematic review and meta-analysis of interpersonal psychotherapy for perinatal women. J Affect Disord. 2018 May;232:316-328. doi: 10.1016/j.jad.2018.01.018. Epub 2018 Feb 1.

  PMID: 29501991 BACKGROUND

• Sockol LE. A systematic review of the efficacy of cognitive behavioral therapy for treating and preventing perinatal depression. J Affect Disord. 2015 May 15;177:7-21. doi: 10.1016/j.jad.2015.01.052. Epub 2015 Feb 2.

  PMID: 25743368 BACKGROUND

• Haga SM, Drozd F, Lisoy C, Wentzel-Larsen T, Slinning K. Mamma Mia - A randomized controlled trial of an internet-based intervention for perinatal depression. Psychol Med. 2019 Aug;49(11):1850-1858. doi: 10.1017/S0033291718002544. Epub 2018 Sep 7.

  PMID: 30191779 BACKGROUND

• Shorey S, Ng YPM, Ng ED, Siew AL, Morelius E, Yoong J, Gandhi M. Effectiveness of a Technology-Based Supportive Educational Parenting Program on Parental Outcomes (Part 1): Randomized Controlled Trial. J Med Internet Res. 2019 Feb 13;21(2):e10816. doi: 10.2196/10816.

  PMID: 30758289 BACKGROUND

• Goodman JH. Women's attitudes, preferences, and perceived barriers to treatment for perinatal depression. Birth. 2009 Mar;36(1):60-9. doi: 10.1111/j.1523-536X.2008.00296.x.

  PMID: 19278385 BACKGROUND

• Smith-Nielsen J, Matthey S, Lange T, Vaever MS. Validation of the Edinburgh Postnatal Depression Scale against both DSM-5 and ICD-10 diagnostic criteria for depression. BMC Psychiatry. 2018 Dec 20;18(1):393. doi: 10.1186/s12888-018-1965-7.

  PMID: 30572867 BACKGROUND

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Shay Erisson, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Obstetrics and Gynecology

Model Details: 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).

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 4, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share