DepressionPRISMNCT02760004
PRogram In Support of Moms: An Innovative Stepped-Care Approach for Obstetrics and Gynecology Clinics
A study testing PRogram In Support of Moms (PRISM) and MCPAP for Moms in people with Depression, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The primary goal of this study is to develop, evaluate, and share a new low-cost program for Obstetrics/Gynecology (Ob/Gyn) practices which will help to improve depression treatment for women during pregnancy and after childbirth. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Depression
- What is being tested?
- PRogram In Support of Moms (PRISM) and MCPAP for Moms
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2017to 31 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- Age 18-55 years
- English speaking
- >4 weeks Gestational age (GA) until 4 months postpartum
- Receiving care from one of the 10 participating practices (five will participate in PRISM (intervention group) and five will have access to MCPAP For Moms (comparison group)
- Edinburgh Postnatal Depression Scale score (EPDS) ≥10
- Able to communicate in written and spoken English; and
- Cognitively able to participate in informed verbal consent
Who cannot join
- Lack of verbal and written English fluency
- Under age 18 or over age 55
- substance use disorder as determined by the questions in 4 Ps questionnaire
- Screen positive for bipolar disorder via the Mood Disorder Questionnaire (MDQ)
- Prisoner
- Women participating in 'Moms do care' study
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Medical School/UMass Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
The primary goal of this study is to develop, evaluate, and share a new low-cost program for Obstetrics/Gynecology (Ob/Gyn) practices which will help to improve depression treatment for women during pregnancy and after childbirth.
Read the detailed description
Upwards of 1 in 5 women suffer from depression during pregnancy or within a year after giving birth. It has negative effects on birth outcomes, infant attachment, and children's behavior/development. Maternal suicide causes 20% of postpartum deaths in depressed women. Although the vast majority of perinatal women are amenable to being screened for depression, screening alone does not improve treatment rates or patient outcomes. Ob/Gyn practices need supports in place to adequately address depression in their patient populations. Thus, the Investigators developed and pilot tested the PRogram In Support of Moms (PRISM), to create a comprehensive intervention that is proactive, multifaceted, and practical. PRISM aims to improve perinatal depression treatment and treatment response rates through: (1) access to immediate resource provision/referrals and psychiatric telephone consultation for Ob/Gyn providers; (2) clinic-specific implementation of stepped care, including training support and toolkits; and, (3) proactive treatment engagement, patient monitoring, and stepped treatment response to depression screening/assessment. PRISM builds on a low-cost and widely disseminated population-based model for delivering psychiatric care in primary care settings developed by our team. Because it uses existing infrastructure and resources, PRISM, has the potential to be feasible, sustainable, and transportable to other practice settings. The Investigators will compare PRISM vs. MCPAP for Moms which provides access to resource provision/referrals and psychiatric telephone consultation, in a clinical trial in which Investigators will randomize 10 Ob/Gyn practices to either PRISM or MCPAP for Moms (Massachusetts Child Psychiatry Access Program for Moms) - intervention. Patient participants will participate in either PRISM or MCPAP for Moms, depending on what intervention their practice is assigned to. The Investigators will compare the effectiveness of PRISM vs. MCPAP for Moms to improve depression severity and treatment participation in pregnancy through 13 months postpartum among 340 patients (n=170/group).
- Conditions
- Depression
- Being tested
- PRogram In Support of Moms (PRISM), MCPAP for Moms
- Keywords
- Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRogram In Support of Moms (PRISM)Behavioural
Also called Rapid Access to Perinatal Psychiatric care in Depression
- Access to MCPAP for Moms
- PRogram In Support of Moms Toolkit with Stepped Care Algorithms
- Support clinic specific implementation using the Addressing Problems Through Organizational Change (APTOC) platform
- Customization of depression screening for each practice
- Proactively engage and track all women who screen +ve on the Edinburgh Postnatal Depression Scale(EPDS)
- Employ psychoeducation and Motivational Interviewing to engage patients with depression
- medical assistant champion and psychiatrist contact bi-weekly to review cases
- Stepped care treatment to depression screening/assessment
MCPAP for MomsBehavioural
- 30-60 minute presentation on perinatal depression
- Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns
- Access to Ob/Gyn provider assessment and treatment recommendations via one-time face-face MCPAP for Moms psychiatrist patient evaluation
- Access to assessment and treatment protocols in Provider Toolkit
- Resource provision/referrals
| Study group | Role | What they receive |
|---|---|---|
| Prism Intervention | Experimental | PRogram In Support of Moms (PRISM) Receives: Behavioral: PRogram In Support of Moms (PRISM) |
| MCPAP for Moms Intervention | Experimental | MCPAP for Moms (Massachusetts Child Psychiatry Access Program for Moms) Receives: Behavioral: MCPAP for Moms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Edinburgh Postnatal Depression Scale Score (EPDS)
EPDS - Edinburgh Postnatal Depression Scale is an instrument used to measure depression. The score range is 0 to 30. A higher score means more depressed. Depressed perinatal patients receiving care from practices enrolled in PRISM will experience more improvement in depression symptoms than patients receiving care from the MCPAP for Moms practices (2 point difference-of-difference in EPDS).
Measured: Baseline up to 13 months postpartum
Secondary outcomes (2)
Participants Initiating Treatment
Number of depressed perinatal patients receiving care from practices enrolled in PRISM who initiated treatment measured by attendance (i,e. one initial mental health assessment or treatment visit) as compared to women receiving care from practices enrolled in MCPAP for Moms.
Measured: Baseline to up to 13 months postpartum
Participants Sustaining Mental Health Treatment
Sustainment of mental health treatment for depressed perinatal patients receiving care from practices enrolled in PRISM. as measured an average ≥1 mental health visit every 1 month until remission of symptoms or study assessment) as compared to women receiving care from practices enrolled in MCPAP for Moms.
Measured: Baseline to up to 13 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study start11 Oct 2017
- Primary completion16 Mar 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Nancy Byatt, University of Massachusetts, Worcester
- Investigators
- Nancy Byatt, DO, MS, MBA, Principal investigator, University of Massachusetts Medical School/UMass Memorial Health CareTiffany A Moore Simas, MD, MPH, MEd, Principal investigator, University of Massachusetts Medical School/UMass Memorial Health CareJeroan J Allison, MD, MS, Principal investigator, University of Massachusetts Medical School/UMass Memorial Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760004
- Sponsor's protocol ID
- H00009163
- Other IDs
- 1U01DP006093
- Acronym
- PRISM
- Status last verified
- Jun 2024
- First submitted
- 27 Apr 2016
- Last updated
- 10 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD sharing plan is as applicable with CDC requirements and policy. All IPD that underlie results in a publication will be shared. Analysis of the data by approved researchers will only be conducted as delineated in the approved proposal. Only the minimum amount of data necessary to accomplish the proposed analysis will be released and must be destroyed after the specified analysis has been completed. All analyses will be subjected to independent verification.
Publications
Hirschfeld RM, Williams JB, Spitzer RL, Calabrese JR, Flynn L, Keck PE Jr, Lewis L, McElroy SL, Post RM, Rapport DJ, Russell JM, Sachs GS, Zajecka J. Development and validation of a screening instrument for bipolar spectrum disorder: the Mood Disorder Questionnaire. Am J Psychiatry. 2000 Nov;157(11):1873-5. doi: 10.1176/appi.ajp.157.11.1873.
PubMed 11058490Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
PubMed 3651732Chen H, Wang J, Ch'ng YC, Mingoo R, Lee T, Ong J. Identifying mothers with postpartum depression early: integrating perinatal mental health care into the obstetric setting. ISRN Obstet Gynecol. 2011;2011:309189. doi: 10.5402/2011/309189. Epub 2011 Sep 15.
PubMed 21941662Flynn HA, O'Mahen HA, Massey L, Marcus S. The impact of a brief obstetrics clinic-based intervention on treatment use for perinatal depression. J Womens Health (Larchmt). 2006 Dec;15(10):1195-204. doi: 10.1089/jwh.2006.15.1195.
PubMed 17199460Burton A, Patel S, Kaminsky L, Rosario GD, Young R, Fitzsimmons A, Canterino JC. Depression in pregnancy: time of screening and access to psychiatric care. J Matern Fetal Neonatal Med. 2011 Nov;24(11):1321-4. doi: 10.3109/14767058.2010.547234. Epub 2011 Jan 24.
PubMed 21261444Goodman JH, Tyer-Viola L. Detection, treatment, and referral of perinatal depression and anxiety by obstetrical providers. J Womens Health (Larchmt). 2010 Mar;19(3):477-90. doi: 10.1089/jwh.2008.1352.
PubMed 20156110Glavin K, Smith L, Sorum R, Ellefsen B. Redesigned community postpartum care to prevent and treat postpartum depression in women--a one-year follow-up study. J Clin Nurs. 2010 Nov;19(21-22):3051-62. doi: 10.1111/j.1365-2702.2010.03332.x. Epub 2010 Aug 19.
PubMed 20726926Glavin K, Smith L, Sorum R. Prevalence of postpartum depression in two municipalities in Norway. Scand J Caring Sci. 2009 Dec;23(4):705-10. doi: 10.1111/j.1471-6712.2008.00667.x. Epub 2009 Aug 29.
PubMed 19490523Chaudron LH, Kitzman HJ, Peifer KL, Morrow S, Perez LM, Newman MC. Prevalence of maternal depressive symptoms in low-income Hispanic women. J Clin Psychiatry. 2005 Apr;66(4):418-23. doi: 10.4088/jcp.v66n0402.
PubMed 15816782Delucchi KL, Tajima B, Guydish J. Development of the Smoking Knowledge, Attitudes, and Practices (S-KAP) Instrument. J Drug Issues. 2009 Mar;39(2):347-364. doi: 10.1177/002204260903900207.
PubMed 20717496McDonald SD, Calhoun PS. The diagnostic accuracy of the PTSD checklist: a critical review. Clin Psychol Rev. 2010 Dec;30(8):976-87. doi: 10.1016/j.cpr.2010.06.012. Epub 2010 Jul 6.
PubMed 20705376Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Swanson LM, Flynn HA, Wilburn K, Marcus S, Armitage R. Maternal mood and sleep in children of women at risk for perinatal depression. Arch Womens Ment Health. 2010 Dec;13(6):531-4. doi: 10.1007/s00737-010-0177-z. Epub 2010 Jul 14.
PubMed 20628772Clement S, Brohan E, Jeffery D, Henderson C, Hatch SL, Thornicroft G. Development and psychometric properties the Barriers to Access to Care Evaluation scale (BACE) related to people with mental ill health. BMC Psychiatry. 2012 Jun 20;12:36. doi: 10.1186/1471-244X-12-36.
PubMed 22546012Cooper LA, Brown C, Vu HT, Palenchar DR, Gonzales JJ, Ford DE, Powe NR. Primary care patients' opinions regarding the importance of various aspects of care for depression. Gen Hosp Psychiatry. 2000 May-Jun;22(3):163-73. doi: 10.1016/s0163-8343(00)00073-6.
PubMed 10880709
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRogram In Support of Moms: An Innovative Stepped-Care Approach for Obstetrics and Gynecology Clinics
- ClinicalTrials.gov ID
- NCT02760004
- Acronym / sponsor ID
- PRISM / H00009163
- Conditions
- Depression
- Keywords
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 3 May 2016 (estimated)
- Results
- Posted 10 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of this study is to develop, evaluate, and share a new low-cost program for Obstetrics/Gynecology (Ob/Gyn) practices which will help to improve depression treatment for women during pregnancy and after childbirth.
Detailed description
Upwards of 1 in 5 women suffer from depression during pregnancy or within a year after giving birth. It has negative effects on birth outcomes, infant attachment, and children's behavior/development. Maternal suicide causes 20% of postpartum deaths in depressed women. Although the vast majority of perinatal women are amenable to being screened for depression, screening alone does not improve treatment rates or patient outcomes. Ob/Gyn practices need supports in place to adequately address depression in their patient populations. Thus, the Investigators developed and pilot tested the PRogram In Support of Moms (PRISM), to create a comprehensive intervention that is proactive, multifaceted, and practical. PRISM aims to improve perinatal depression treatment and treatment response rates through: (1) access to immediate resource provision/referrals and psychiatric telephone consultation for Ob/Gyn providers; (2) clinic-specific implementation of stepped care, including training support and toolkits; and, (3) proactive treatment engagement, patient monitoring, and stepped treatment response to depression screening/assessment. PRISM builds on a low-cost and widely disseminated population-based model for delivering psychiatric care in primary care settings developed by our team. Because it uses existing infrastructure and resources, PRISM, has the potential to be feasible, sustainable, and transportable to other practice settings. The Investigators will compare PRISM vs. MCPAP for Moms which provides access to resource provision/referrals and psychiatric telephone consultation, in a clinical trial in which Investigators will randomize 10 Ob/Gyn practices to either PRISM or MCPAP for Moms (Massachusetts Child Psychiatry Access Program for Moms) - intervention. Patient participants will participate in either PRISM or MCPAP for Moms, depending on what intervention their practice is assigned to. The Investigators will compare the effectiveness of PRISM vs. MCPAP for Moms to improve depression severity and treatment participation in pregnancy through 13 months postpartum among 340 patients (n=170/group).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prism Intervention | Experimental | Behavioral: PRogram In Support of Moms (PRISM)PRogram In Support of Moms (PRISM) |
| MCPAP for Moms Intervention | Experimental | Behavioral: MCPAP for MomsMCPAP for Moms (Massachusetts Child Psychiatry Access Program for Moms) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Female
- Age 18-55 years
- English speaking
- >4 weeks Gestational age (GA) until 4 months postpartum
- Receiving care from one of the 10 participating practices (five will participate in PRISM (intervention group) and five will have access to MCPAP For Moms (comparison group)
Key exclusion criteria (6 listed)
- Lack of verbal and written English fluency
- Under age 18 or over age 55
- substance use disorder as determined by the questions in 4 Ps questionnaire
- Screen positive for bipolar disorder via the Mood Disorder Questionnaire (MDQ)
- Prisoner
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 |
|---|---|---|
| PRogram In Support of Moms (PRISM)Also: Rapid Access to Perinatal Psychiatric care in Depression* Access to MCPAP for Moms * PRogram In Support of Moms Toolkit with Stepped Care Algorithms * Support clinic specific implementation using the Addressing Problems Through Organizational Change (APTOC) platform * Customization of depression screening for each practice * Proactively engage and track all women who screen +ve on the Edinburgh Postnatal Depression Scale(EPDS) * Employ psychoeducation and Motivational Interviewing to engage patients with depression * medical assistant champion and psychiatrist contact bi-weekly to review cases * Stepped care treatment to depression screening/assessment | Behavioural | Prism Intervention |
| MCPAP for Moms* 30-60 minute presentation on perinatal depression * Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns * Access to Ob/Gyn provider assessment and treatment recommendations via one-time face-face MCPAP for Moms psychiatrist patient evaluation * Access to assessment and treatment protocols in Provider Toolkit * Resource provision/referrals | Behavioural | MCPAP for Moms Intervention |
Primary outcome
Change in Edinburgh Postnatal Depression Scale Score (EPDS)
Time frame: Baseline up to 13 months postpartum
EPDS - Edinburgh Postnatal Depression Scale is an instrument used to measure depression. The score range is 0 to 30. A higher score means more depressed. Depressed perinatal patients receiving care from practices enrolled in PRISM will experience more improvement in depression symptoms than patients receiving care from the MCPAP for Moms practices (2 point difference-of-difference in EPDS).
2 secondary outcomes
Participants Initiating Treatment
Time frame: Baseline to up to 13 months postpartum
Participants Sustaining Mental Health Treatment
Time frame: Baseline to up to 13 months postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11058490Hirschfeld RM, Williams JB, Spitzer RL, Calabrese JR, Flynn L, Keck PE Jr, Lewis L, McElroy SL, Post RM, Rapport DJ, Russell JM, Sachs GS, Zajecka J. Development and validation of a screening instrument for bipolar spectrum disorder: the Mood Disorder Questionnaire. Am J Psychiatry. 2000 Nov;157(11):1873-5. doi: 10.1176/appi.ajp.157.11.1873.
- Background: PubMed 3651732Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
- Background: PubMed 21941662Chen H, Wang J, Ch'ng YC, Mingoo R, Lee T, Ong J. Identifying mothers with postpartum depression early: integrating perinatal mental health care into the obstetric setting. ISRN Obstet Gynecol. 2011;2011:309189. doi: 10.5402/2011/309189. Epub 2011 Sep 15.
- Background: PubMed 17199460Flynn HA, O'Mahen HA, Massey L, Marcus S. The impact of a brief obstetrics clinic-based intervention on treatment use for perinatal depression. J Womens Health (Larchmt). 2006 Dec;15(10):1195-204. doi: 10.1089/jwh.2006.15.1195.
- Background: PubMed 21261444Burton A, Patel S, Kaminsky L, Rosario GD, Young R, Fitzsimmons A, Canterino JC. Depression in pregnancy: time of screening and access to psychiatric care. J Matern Fetal Neonatal Med. 2011 Nov;24(11):1321-4. doi: 10.3109/14767058.2010.547234. Epub 2011 Jan 24.
- Background: PubMed 20156110Goodman JH, Tyer-Viola L. Detection, treatment, and referral of perinatal depression and anxiety by obstetrical providers. J Womens Health (Larchmt). 2010 Mar;19(3):477-90. doi: 10.1089/jwh.2008.1352.
- Background: PubMed 20726926Glavin K, Smith L, Sorum R, Ellefsen B. Redesigned community postpartum care to prevent and treat postpartum depression in women--a one-year follow-up study. J Clin Nurs. 2010 Nov;19(21-22):3051-62. doi: 10.1111/j.1365-2702.2010.03332.x. Epub 2010 Aug 19.
- Background: PubMed 19490523Glavin K, Smith L, Sorum R. Prevalence of postpartum depression in two municipalities in Norway. Scand J Caring Sci. 2009 Dec;23(4):705-10. doi: 10.1111/j.1471-6712.2008.00667.x. Epub 2009 Aug 29.
- Background: PubMed 15816782Chaudron LH, Kitzman HJ, Peifer KL, Morrow S, Perez LM, Newman MC. Prevalence of maternal depressive symptoms in low-income Hispanic women. J Clin Psychiatry. 2005 Apr;66(4):418-23. doi: 10.4088/jcp.v66n0402.
- Background: PubMed 20717496Delucchi KL, Tajima B, Guydish J. Development of the Smoking Knowledge, Attitudes, and Practices (S-KAP) Instrument. J Drug Issues. 2009 Mar;39(2):347-364. doi: 10.1177/002204260903900207.
- Background: PubMed 20705376McDonald SD, Calhoun PS. The diagnostic accuracy of the PTSD checklist: a critical review. Clin Psychol Rev. 2010 Dec;30(8):976-87. doi: 10.1016/j.cpr.2010.06.012. Epub 2010 Jul 6.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Individual participant dataSharing planned: Yes. IPD sharing plan is as applicable with CDC requirements and policy. All IPD that underlie results in a publication will be shared. Analysis of the data by approved researchers will only be conducted as delineated in the approved proposal. Only the minimum amount of data necessary to accomplish the proposed analysis will be released and must be destroyed after the specified analysis has been completed. All analyses will be subjected to independent verification.
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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.
Nancy Byatt, DO, MS, MBA principal investigator
University of Massachusetts Medical School/UMass Memorial Health Care
Tiffany A Moore Simas, MD, MPH, MEd principal investigator
University of Massachusetts Medical School/UMass Memorial Health Care
Jeroan J Allison, MD, MS principal investigator
University of Massachusetts Medical School/UMass Memorial Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRogram In Support of Moms (PRISM) and MCPAP for Moms in people with Depression, run by University of Massachusetts, Worcester at 1 site in United States.
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 8 inclusion and 6 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: finished, as of the sponsor's last update on 10 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 10 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Edinburgh Postnatal Depression Scale Score (EPDS) (time frame: Baseline up to 13 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 NCT02760004, which also lists 27 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 10 Jun 2024.