Prospective Study Evaluating a Novel Mobile App Based Preventive Behavioral Intervention for Perinatal Mood Disorders
NCT ID: NCT04914299
Last Updated: 2025-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2021-07-01
2022-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
New Moms Mood Tracking & Wellbeing
NCT05056454
Mobile App for Mood in Pregnancy (Ginger iO)
NCT02761720
How Does Mindful Mood Balance for Moms Work?
NCT05000879
A Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women With Depression
NCT04495166
Accelerating Implementation of Mindful Mood Balance for Moms
NCT04846504
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A novel mobile-App based intervention
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.
App-based "positive intelligence" intervention
A 6 weeks App-guided and support-group based "positive intelligence" cognitive behavioral intervention in addition to standard prenatal and postnatal care
Standard of care
Standard prenatal and postnatal care(Providing psychoeducation and referral to psychotherapy or pharmacotherapy based on participant's symptoms).
Standard of Care
Standard prenatal care and follow up
Standard of care
Standard prenatal and postnatal care(Providing psychoeducation and referral to psychotherapy or pharmacotherapy based on participant's symptoms).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
App-based "positive intelligence" intervention
A 6 weeks App-guided and support-group based "positive intelligence" cognitive behavioral intervention in addition to standard prenatal and postnatal care
Standard of care
Standard prenatal and postnatal care(Providing psychoeducation and referral to psychotherapy or pharmacotherapy based on participant's symptoms).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Positive Intelligence Inc.
UNKNOWN
Massachusetts General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Shay Erisson
Physician, Obstetrics and Gynecology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shay Erisson, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
ACOG Committee Opinion No. 757: Screening for Perinatal Depression. Obstet Gynecol. 2018 Nov;132(5):e208-e212. doi: 10.1097/AOG.0000000000002927.
ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2021P001387
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.