Perinatal DepressionNCT04914299
Prospective Study Evaluating a Novel Mobile App Based Preventive Behavioral Intervention for Perinatal Mood Disorders
A study testing App-based "positive intelligence" intervention in people with Perinatal Depression and Perinatal Anxiety, run by Massachusetts General Hospital.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perinatal Depression, Perinatal Anxiety
- What is being tested?
- App-based "positive intelligence" intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2021to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Positive Intelligence - Prospective Study Evaluating a Novel Mobile App Based Preventive Behavioral Intervention for Perinatal Mood Disorders
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.
Read the 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.
- Conditions
- Perinatal Depression, Perinatal Anxiety
- Being tested
- App-based "positive intelligence" intervention, Standard of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based "positive intelligence" interventionBehavioural
A 6 weeks App-guided and support-group based "positive intelligence" cognitive behavioral intervention in addition to standard prenatal and postnatal care
Standard of careBehavioural
Standard prenatal and postnatal care(Providing psychoeducation and referral to psychotherapy or pharmacotherapy based on participant's symptoms).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: App-based "positive intelligence" intervention; Behavioral: Standard of care |
| Standard of Care | Active comparator | Standard prenatal care and follow up Receives: Behavioral: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3rd trimester pregnancy till 6 months postpartum
Secondary outcomes (4)
Completion of App-based intervention program
Self reported completion of App based 6 weeks training program.
Measured: 6 weeks postpartum
Patient Satisfaction
Patient satisfaction measured by Client Satisfaction Questionnaire scale. scale 8-32, with higher scores indicate greater satisfaction.
Measured: 6 weeks postpartum to 6 months postpartum
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.
Measured: 3rd trimester pregnancy till 6 months postpartum
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.
Measured: 3rd trimester pregnancy till 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start1 Jul 2021 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Why it stopped: no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Positive Intelligence Inc.
- Responsible party
- Principal investigator, Shay Erisson, Massachusetts General Hospital
- Investigators
- Shay Erisson, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914299
- Sponsor's protocol ID
- 2021P001387
- Status last verified
- Nov 2025
- First submitted
- 31 May 2021
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25932866ACOG Committee Opinion No. 757: Screening for Perinatal Depression. Obstet Gynecol. 2018 Nov;132(5):e208-e212. doi: 10.1097/AOG.0000000000002927.
PubMed 30629567ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.
PubMed 29683911Morrell 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.
PubMed 27184772US 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.
PubMed 30747971Zlotnick 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.
PubMed 11282702Zlotnick 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.
PubMed 16877662McFarlane 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.
PubMed 27535131Pessagno 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.
PubMed 23819670O'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.
PubMed 30747970Liu 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.
PubMed 33397393Avalos 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.
PubMed 27054938Byatt 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.
PubMed 23194018Sockol 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.
PubMed 29501991Sockol 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.
PubMed 25743368
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Intelligence - Prospective Study Evaluating a Novel Mobile App Based Preventive Behavioral Intervention for Perinatal Mood Disorders
- ClinicalTrials.gov ID
- NCT04914299
- Acronym / sponsor ID
- 2021P001387
- Conditions
- Perinatal Depression, Perinatal Anxiety
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Positive Intelligence Inc.
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| A novel mobile-App based intervention | Experimental | Behavioral: App-based "positive intelligence" intervention, Behavioral: Standard of careAn 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 of Care | Active comparator | Behavioral: Standard of careStandard prenatal care and follow up |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App-based "positive intelligence" interventionA 6 weeks App-guided and support-group based "positive intelligence" cognitive behavioral intervention in addition to standard prenatal and postnatal care | Behavioural | A novel mobile-App based intervention |
| Standard of careStandard prenatal and postnatal care(Providing psychoeducation and referral to psychotherapy or pharmacotherapy based on participant's symptoms). | Behavioural | A novel mobile-App based intervention, Standard of Care |
Primary outcome
Postpartum Depression Symptoms
Time frame: 3rd trimester pregnancy till 6 months postpartum
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.
4 secondary outcomes
Completion of App-based intervention program
Time frame: 6 weeks postpartum
Patient Satisfaction
Time frame: 6 weeks postpartum to 6 months postpartum
Generalized Anxiety Symptoms
Time frame: 3rd trimester pregnancy till 6 months postpartum
Patient depression symptoms and severity
Time frame: 3rd trimester pregnancy till 6 months postpartum
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Background: PubMed 25932866The 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.
- Background: PubMed 30629567ACOG Committee Opinion No. 757: Screening for Perinatal Depression. Obstet Gynecol. 2018 Nov;132(5):e208-e212. doi: 10.1097/AOG.0000000000002927.
- Background: PubMed 29683911ACOG Committee Opinion No. 736: Optimizing Postpartum Care. Obstet Gynecol. 2018 May;131(5):e140-e150. doi: 10.1097/AOG.0000000000002633.
- Background: PubMed 27184772Morrell 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.
- Background: PubMed 30747971US 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.
- Background: PubMed 11282702Zlotnick 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.
- Background: PubMed 16877662Zlotnick 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.
- Background: PubMed 27535131McFarlane 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.
- Background: PubMed 23819670Pessagno 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.
- Background: PubMed 30747970O'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.
- Background: PubMed 33397393Liu 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.
- Background: PubMed 27054938Avalos 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shay Erisson, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing App-based "positive intelligence" intervention in people with Perinatal Depression and Perinatal Anxiety, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum Depression Symptoms (time frame: 3rd trimester pregnancy till 6 months postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04914299, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.