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

Perinatal Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04914299
• Other study ID #: 2021P001387
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: June 2021
• Source: Massachusetts General Hospital
• Contact: Shay Erisson, MD
• Phone: 6173322345
• Email: serisson[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Mood Disorders
• Perinatal Anxiety
• Perinatal Depression

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Positive Intelligence Inc.

References & Publications (19)

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

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

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. — View Citation

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. Review. — View Citation

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. — View Citation

Haga SM, Drozd F, Lisøy 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Shorey S, Ng YPM, Ng ED, Siew AL, Mörelius 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. — View Citation

Smith-Nielsen J, Matthey S, Lange T, Væver 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. — View Citation

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. Review. — View Citation

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. Review. — View 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. — View 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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Completion of App-based intervention program	Self reported completion of App based 6 weeks training program.	6 weeks postpartum
Secondary	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
Secondary	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
Secondary	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