Perinatal DepressionSUMMITNCT04153864
Scaling Up Maternal Mental Healthcare by Increasing Access to Treatment (SUMMIT)
A study testing Brief Behavioral Activation Treatment in people with Perinatal Depression, run by Mount Sinai Hospital, Canada at 5 sites in 2 countries.
Trial summary
SUMMIT's (Scaling Up Maternal Mental health care by Increasing access to Treatment) overarching goal is to examine the scalability and patient-centered provision of brief, evidence-based psychological treatments for perinatal depression and anxiety (N=1226). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perinatal Depression
- What is being tested?
- Brief Behavioral Activation Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,230 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 6 Jan 2020to 13 Feb 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- EPDS≥10
- ≥18 years
- Pregnant up to 36 weeks or 4-30 weeks postpartum
- Speaks English or (US sites) Spanish
Who cannot join
- Active suicidal intent (ideation and plan), active symptoms of psychosis or mania
- Psychotropic medication dose or medication change within two weeks of enrollment or beginning treatment
- Ongoing psychotherapy (no more than once every 8 weeks or during the duration of the intervention)
- Active substance abuse or dependence
- Severe fetal anomalies, stillbirth or infant death at time of enrollment for index pregnancy
- Non-English, non-Spanish speakers
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Canada3 sites
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Sinai Health System
Toronto, Ontario, M5G 1X5
Women's College Hospital
Toronto, Ontario, M5S 1B2
United States2 sites
University of North Carolina
Chapel Hill, North Carolina, 27514
NorthShore University Health System
Evanston, Illinois, 60201
About this study
Official title: Scaling Up Maternal Mental Healthcare by Increasing Access to Treatment (SUMMIT): A Pragmatic, Non-inferiority Trial for Perinatal Depression and Anxiety
SUMMIT's (Scaling Up Maternal Mental health care by Increasing access to Treatment) overarching goal is to examine the scalability and patient-centered provision of brief, evidence-based psychological treatments for perinatal depression and anxiety (N=1226). Specifically, and through a multi-site, randomized, pragmatic trial, the trial examines whether a brief, behavioral activation (BA) treatment delivered via telemedicine is as effective as the same treatment delivered in person; and whether BA delivered by non-mental health providers (e.g., nurses), with appropriate training is as effective as when delivered by specialist providers (psychiatrists, psychologists and social workers) in reducing perinatal depressive and anxiety symptoms. The study will be conducted in Toronto, NorthShore University HealthSystem in Evanston and surrounding areas including Chicago, and North Carolina. The trial will also identify relevant underlying implementation processes and determine whether, and to what extent, these strategies work differentially for certain women over others.
Read the detailed description
Eligible participants are randomly assigned to the same BA treatment for perinatal depressive and anxiety symptoms in one of four arms: 1) In-person specialist; 2) Telemedicine specialist; 3) In-person non-specialist; 4) Telemedicine non-specialist. However, due to the COVID-19 pandemic, recruitment was adjusted as below:
- March 2020-July 2021: For the duration of the COVID-19 pandemic period participants were only randomized 1:1 to 1) Telemedicine non-specialist; 2) Telemedicine specialist.
- July 2021 to January 2022: Randomization of participants to all 4 arms resumed, using a raking approach (weight ratio of 3:1 favoring In-Person to Telemedicine), to rebalance the arms.
- January 2022 to April 2022: In light of the COVID-19 Omicron variant, participants were only randomized 1:1 to 1) Telemedicine non-specialist; 2) Telemedicine specialist.
- April 2022 to present: Randomization of participants to all 4 arms resumed at all sites (ratio 1:1:1:1) to 1) In-person specialist; 2) Telemedicine specialist; 3) In-person non-specialist; 4) Telemedicine non-specialist. Randomization to all 4 arms will be followed until in-person arms are fully enrolled after which randomization 1:1 to the two telemedicine arms will be followed. A flexible study design was established at each site based on site-specific COVID restrictions.
This approach was verified by the study statistician, an independent methodologist and the study funder. All analyses will be run as both intent-to-treat and per protocol.
- Conditions
- Perinatal Depression
- Being tested
- Brief Behavioral Activation Treatment
- Keywords
- Depression, Anxiety, Maternal mental health, Behavioral Activation
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Behavioral Activation TreatmentBehavioural
Also called Brief evidence-based Psychological Treatment of BA for perinatal depressive and anxiety symptoms
A manualized 6-8 session BA treatment delivered individually to each participant.
| Study group | Role | What they receive |
|---|---|---|
| Non-specialist | Experimental | Trained non-mental health providers (e.g., nurses or midwives) with general healthcare professional skills (as assessed during recruitment) with no previous experience delivering psychological treatments implementing a brief, manualized behavioral activation treatment Receives: Behavioral: Brief Behavioral Activation Treatment |
| Specialist | Active comparator | Psychiatrists, psychologists and social workers with experience in treating perinatal mental illness and a minimum of 5 years of experience delivering psychological treatments delivering a brief, manualized behavioral activation treatment Receives: Behavioral: Brief Behavioral Activation Treatment |
| Telemedicine | Experimental | A brief, manualized behavioral activation treatment delivered over Zoom™ in Toronto, via Webex™ in Chapel Hill, and via Zoom™ in NorthShore Receives: Behavioral: Brief Behavioral Activation Treatment |
| In-Person | Active comparator | A brief, manualized behavioral activation treatment delivered in-person held at participating clinical care sites within UToronto, UNC and NorthShore Receives: Behavioral: Brief Behavioral Activation Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptoms: Edinburgh Postnatal Depression Scale (EPDS) Mean Score
Edinburgh Postnatal Depression Scale (EPDS) is a brief, 10-item self-administered questionnaire used to help identify perinatal depressive symptoms. Each item is scored from 0 to 3, with a total summed score ranging from 0-30. Higher EPDS total scores indicates higher severity of depressive symptoms.
Measured: 3-months post-randomization
Secondary outcomes (3)
Depressive Symptoms: Edinburgh Postnatal Depression Scale (EPDS) Mean Score
Edinburgh Postnatal Depression Scale (EPDS) is a brief, 10-item self-administered questionnaire used to help identify perinatal depressive symptoms. Each item is scored from 0 to 3, with a total summed score ranging from 0-30. Higher EPDS total scores indicates higher severity of depressive symptoms.
Measured: 6- and 12-months post-randomization
Anxiety Symptoms: Generalized Anxiety Disorder Scale (GAD-7) Mean Score
Generalized Anxiety Disorder (GAD-7) is a brief, 7-item self-administered questionnaire used to screen for and assess the anxiety symptoms. Each item is scored from 0 to 3, with a total summed score ranging from 0-21. Higher GAD-7 total scores indicates a greater severity of anxiety symptoms.
Measured: 3-months post-randomization
Child Mental Health Development
Child mental development was measured by Bayley Mental Developmental Scale IV and the provision of psychosocial stimulation by the mother (study participant) as measured by the Home Observation Measurement Evaluation. The Bayley Mental Developmental Scale IV was used to measure cognitive development and expressive and receptive language in participants' children. The composite scores are scaled to a metric, with a mean of 100, standard deviation of 15, and range of 40 to 160. Higher scaled scores are associated with higher mental health development in children. The minimum and maximum values for the Home Observation Measurement Evaluation scale scores are 0 and 45 respectively. Higher scores are associated with a more enriched environment.
Measured: 6 to 24 months post child birth (extended due to COVID-19)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start6 Jan 2020
- Primary completion26 Feb 2024
- Study completion13 Feb 2025
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 (13)Papers the sponsor has linked to this study.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The intervention modules include: 1. Brief BA psychological treatment delivered by a non-specialist provider 2. Brief BA psychological treatment delivered through telemedicine
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Endeavor Health, Women's College Hospital, Unity Health Toronto, Sunnybrook Health Sciences Centre, University of Colorado, Boulder, Harvard Medical School (HMS and HSDM), Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Daisy R Singla, PhD, Principal investigator, Sinai Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153864
- Sponsor's protocol ID
- PCS-2018C1-10621
- Acronym
- SUMMIT
- Status last verified
- Jul 2025
- First submitted
- 4 Nov 2019
- Last updated
- 14 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cox 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 3651732Spitzer 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 16717171Bradley RH, Caldwell BM. The HOME Inventory and family demographics. Developmental Psychology 1984; 20(2): 315.
Bayley N. Bayley Scales of Infant Development and Toddler Development: Technical Manual: The PsychCorp; 2006.
McCabe-Beane JE, Segre LS, Perkhounkova Y, Stuart S, O'Hara MW. The identification of severity ranges for the Edinburgh Postnatal Depression Scale. Journal of Reproductive and Infant Psychology. 2016;34(3):293-303.
Simpson W, Glazer M, Michalski N, Steiner M, Frey BN. Comparative efficacy of the generalized anxiety disorder 7-item scale and the Edinburgh Postnatal Depression Scale as screening tools for generalized anxiety disorder in pregnancy and the postpartum period. Can J Psychiatry. 2014 Aug;59(8):434-40. doi: 10.1177/070674371405900806.
PubMed 25161068Andrejek N, Lea Z, Cussons A, Sandeep S, Dennis CL, La Porte LM, Vigod SN, Silver RK, Meltzer-Brody S, Singla DR. Advancing telemedicine and task-sharing to improve access to psychotherapy for perinatal populations. Commun Med (Lond). 2025 Sep 30;5(1):406. doi: 10.1038/s43856-025-01099-9.
PubMed 41028222Zaidan M, Lawson AS, Andrejek N, Walsh K, Dennis CL, Meltzer-Brody S, Silver RK, Stuebe AM, Vigod SN, Singla DR. Bridges to treatment satisfaction: the roles of trauma, social support, race and ethnicity among perinatal women receiving behavioural activation therapy. BMC Med. 2025 Aug 20;23(1):489. doi: 10.1186/s12916-025-04272-y.
PubMed 40835941Kaliush PR, Molina NC, Berenbaum TS, Dennis CL, Gaynes BN, Meltzer-Brody S, Reyes-Rodriguez ML, Silver RK, Stuebe AM, Vigod SN, Schiller CE, Singla DR. Behavioral Activation for Perinatal Suicide Ideation: Secondary Analysis of a Noninferiority Randomized Clinical Trial. JAMA Psychiatry. 2025 Dec 1;82(12):1234-1239. doi: 10.1001/jamapsychiatry.2025.2116.
PubMed 40833774Andrejek N, Ravitz P, Mikelsteins K, La Porte L, Kim JJ, Schiller CE, Reyes-Rodriguez ML, Barker LC, Dennis CL, Silver RK, Meltzer-Brody S, Singla DR. Clinical Supervision Models for Non-specialist Providers Delivering Psychotherapy: A Qualitative Analysis. Adm Policy Ment Health. 2025 Sep;52(5):932-949. doi: 10.1007/s10488-025-01450-1. Epub 2025 Jun 3.
PubMed 40459806Singla DR, Silver RK, Vigod SN, Schoueri-Mychasiw N, Kim JJ, La Porte LM, Ravitz P, Schiller CE, Lawson AS, Kiss A, Hollon SD, Dennis CL, Berenbaum TS, Krohn HA, Gibori JE, Charlebois J, Clark DM, Dalfen AK, Davis W, Gaynes BN, Leszcz M, Katz SR, Murphy KE, Naslund JA, Reyes-Rodriguez ML, Stuebe AM, Zlobin C, Mulsant BH, Patel V, Meltzer-Brody S. Task-sharing and telemedicine delivery of psychotherapy to treat perinatal depression: a pragmatic, noninferiority randomized trial. Nat Med. 2025 Apr;31(4):1214-1224. doi: 10.1038/s41591-024-03482-w. Epub 2025 Mar 3.
PubMed 40033113Singla DR, Hossain S, Andrejek N, Cohen MJ, Dennis CL, Kim J, La Porte L, Meltzer-Brody SE, Puerto Nino A, Ravitz P, Schoueri-Mychasiw N, Silver R, Vigod SN, Zibaman M, Schiller CE. Culturally sensitive psychotherapy for perinatal women: A mixed methods study. J Consult Clin Psychol. 2022 Oct;90(10):770-786. doi: 10.1037/ccp0000754. Epub 2022 Sep 29.
PubMed 36174135Singla DR, Meltzer-Brody SE, Silver RK, Vigod SN, Kim JJ, La Porte LM, Ravitz P, Schiller CE, Schoueri-Mychasiw N, Hollon SD, Kiss A, Clark D, Dalfen AK, Dimidjian S, Gaynes BN, Katz SR, Lawson A, Leszcz M, Maunder RG, Mulsant BH, Murphy KE, Naslund JA, Reyes-Rodriguez ML, Stuebe AM, Dennis CL, Patel V. Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) through non-specialist providers and telemedicine: a study protocol for a non-inferiority randomized controlled trial. Trials. 2021 Mar 5;22(1):186. doi: 10.1186/s13063-021-05075-1.
PubMed 33673867
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling Up Maternal Mental Healthcare by Increasing Access to Treatment (SUMMIT): A Pragmatic, Non-inferiority Trial for Perinatal Depression and Anxiety
- ClinicalTrials.gov ID
- NCT04153864
- Acronym / sponsor ID
- SUMMIT / PCS-2018C1-10621
- Conditions
- Perinatal Depression
- Keywords
- Depression, Anxiety, Maternal mental health, Behavioral Activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,230 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, Endeavor Health, Women's College Hospital, Unity Health Toronto, Sunnybrook Health Sciences Centre, University of Colorado, Boulder, Harvard Medical School (HMS and HSDM), Patient-Centered Outcomes Research Institute
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 13 Feb 2025 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Posted 14 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SUMMIT's (Scaling Up Maternal Mental health care by Increasing access to Treatment) overarching goal is to examine the scalability and patient-centered provision of brief, evidence-based psychological treatments for perinatal depression and anxiety (N=1226). Specifically, and through a multi-site, randomized, pragmatic trial, the trial examines whether a brief, behavioral activation (BA) treatment delivered via telemedicine is as effective as the same treatment delivered in person; and whether BA delivered by non-mental health providers (e.g., nurses), with appropriate training is as effective as when delivered by specialist providers (psychiatrists, psychologists and social workers) in reducing perinatal depressive and anxiety symptoms. The study will be conducted in Toronto, NorthShore University HealthSystem in Evanston and surrounding areas including Chicago, and North Carolina. The trial will also identify relevant underlying implementation processes and determine whether, and to what extent, these strategies work differentially for certain women over others.
Detailed description
Eligible participants are randomly assigned to the same BA treatment for perinatal depressive and anxiety symptoms in one of four arms: 1) In-person specialist; 2) Telemedicine specialist; 3) In-person non-specialist; 4) Telemedicine non-specialist. However, due to the COVID-19 pandemic, recruitment was adjusted as below:
- March 2020-July 2021: For the duration of the COVID-19 pandemic period participants were only randomized 1:1 to 1) Telemedicine non-specialist; 2) Telemedicine specialist.
- July 2021 to January 2022: Randomization of participants to all 4 arms resumed, using a raking approach (weight ratio of 3:1 favoring In-Person to Telemedicine), to rebalance the arms.
- January 2022 to April 2022: In light of the COVID-19 Omicron variant, participants were only randomized 1:1 to 1) Telemedicine non-specialist; 2) Telemedicine specialist.
- April 2022 to present: Randomization of participants to all 4 arms resumed at all sites (ratio 1:1:1:1) to 1) In-person specialist; 2) Telemedicine specialist; 3) In-person non-specialist; 4) Telemedicine non-specialist. Randomization to all 4 arms will be followed until in-person arms are fully enrolled after which randomization 1:1 to the two telemedicine arms will be followed. A flexible study design was established at each site based on site-specific COVID restrictions.
This approach was verified by the study statistician, an independent methodologist and the study funder. All analyses will be run as both intent-to-treat and per protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The intervention modules include: 1. Brief BA psychological treatment delivered by a non-specialist provider 2. Brief BA psychological treatment delivered through telemedicine
| Arm | Type | Receives |
|---|---|---|
| Non-specialist | Experimental | Behavioral: Brief Behavioral Activation TreatmentTrained non-mental health providers (e.g., nurses or midwives) with general healthcare professional skills (as assessed during recruitment) with no previous experience delivering psychological treatments implementing a brief, manualized behavioral activation treatment |
| Specialist | Active comparator | Behavioral: Brief Behavioral Activation TreatmentPsychiatrists, psychologists and social workers with experience in treating perinatal mental illness and a minimum of 5 years of experience delivering psychological treatments delivering a brief, manualized behavioral activation treatment |
| Telemedicine | Experimental | Behavioral: Brief Behavioral Activation TreatmentA brief, manualized behavioral activation treatment delivered over Zoom™ in Toronto, via Webex™ in Chapel Hill, and via Zoom™ in NorthShore |
| In-Person | Active comparator | Behavioral: Brief Behavioral Activation TreatmentA brief, manualized behavioral activation treatment delivered in-person held at participating clinical care sites within UToronto, UNC and NorthShore |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- EPDS≥10
- ≥18 years
- Pregnant up to 36 weeks or 4-30 weeks postpartum
- Speaks English or (US sites) Spanish
Key exclusion criteria (6 listed)
- Active suicidal intent (ideation and plan), active symptoms of psychosis or mania
- Psychotropic medication dose or medication change within two weeks of enrollment or beginning treatment
- Ongoing psychotherapy (no more than once every 8 weeks or during the duration of the intervention)
- Active substance abuse or dependence
- Severe fetal anomalies, stillbirth or infant death at time of enrollment for index pregnancy
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 |
|---|---|---|
| Brief Behavioral Activation TreatmentAlso: Brief evidence-based Psychological Treatment of BA for perinatal depressive and anxiety symptomsA manualized 6-8 session BA treatment delivered individually to each participant. | Behavioural | In-Person, Non-specialist, Specialist, Telemedicine |
Primary outcome
Depressive Symptoms: Edinburgh Postnatal Depression Scale (EPDS) Mean Score
Time frame: 3-months post-randomization
Edinburgh Postnatal Depression Scale (EPDS) is a brief, 10-item self-administered questionnaire used to help identify perinatal depressive symptoms. Each item is scored from 0 to 3, with a total summed score ranging from 0-30. Higher EPDS total scores indicates higher severity of depressive symptoms.
3 secondary outcomes
Depressive Symptoms: Edinburgh Postnatal Depression Scale (EPDS) Mean Score
Time frame: 6- and 12-months post-randomization
Anxiety Symptoms: Generalized Anxiety Disorder Scale (GAD-7) Mean Score
Time frame: 3-months post-randomization
Child Mental Health Development
Time frame: 6 to 24 months post child birth (extended due to COVID-19)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 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.
- BackgroundBradley RH, Caldwell BM. The HOME Inventory and family demographics. Developmental Psychology 1984; 20(2): 315.
- BackgroundBayley N. Bayley Scales of Infant Development and Toddler Development: Technical Manual: The PsychCorp; 2006.
- BackgroundMcCabe-Beane JE, Segre LS, Perkhounkova Y, Stuart S, O'Hara MW. The identification of severity ranges for the Edinburgh Postnatal Depression Scale. Journal of Reproductive and Infant Psychology. 2016;34(3):293-303.
- Background: PubMed 25161068Simpson W, Glazer M, Michalski N, Steiner M, Frey BN. Comparative efficacy of the generalized anxiety disorder 7-item scale and the Edinburgh Postnatal Depression Scale as screening tools for generalized anxiety disorder in pregnancy and the postpartum period. Can J Psychiatry. 2014 Aug;59(8):434-40. doi: 10.1177/070674371405900806.
- Derived from this study: PubMed 41028222Andrejek N, Lea Z, Cussons A, Sandeep S, Dennis CL, La Porte LM, Vigod SN, Silver RK, Meltzer-Brody S, Singla DR. Advancing telemedicine and task-sharing to improve access to psychotherapy for perinatal populations. Commun Med (Lond). 2025 Sep 30;5(1):406. doi: 10.1038/s43856-025-01099-9.
- Derived from this study: PubMed 40835941Zaidan M, Lawson AS, Andrejek N, Walsh K, Dennis CL, Meltzer-Brody S, Silver RK, Stuebe AM, Vigod SN, Singla DR. Bridges to treatment satisfaction: the roles of trauma, social support, race and ethnicity among perinatal women receiving behavioural activation therapy. BMC Med. 2025 Aug 20;23(1):489. doi: 10.1186/s12916-025-04272-y.
- Derived from this study: PubMed 40833774Kaliush PR, Molina NC, Berenbaum TS, Dennis CL, Gaynes BN, Meltzer-Brody S, Reyes-Rodriguez ML, Silver RK, Stuebe AM, Vigod SN, Schiller CE, Singla DR. Behavioral Activation for Perinatal Suicide Ideation: Secondary Analysis of a Noninferiority Randomized Clinical Trial. JAMA Psychiatry. 2025 Dec 1;82(12):1234-1239. doi: 10.1001/jamapsychiatry.2025.2116.
- Derived from this study: PubMed 40459806Andrejek N, Ravitz P, Mikelsteins K, La Porte L, Kim JJ, Schiller CE, Reyes-Rodriguez ML, Barker LC, Dennis CL, Silver RK, Meltzer-Brody S, Singla DR. Clinical Supervision Models for Non-specialist Providers Delivering Psychotherapy: A Qualitative Analysis. Adm Policy Ment Health. 2025 Sep;52(5):932-949. doi: 10.1007/s10488-025-01450-1. Epub 2025 Jun 3.
- Derived from this study: PubMed 40033113Singla DR, Silver RK, Vigod SN, Schoueri-Mychasiw N, Kim JJ, La Porte LM, Ravitz P, Schiller CE, Lawson AS, Kiss A, Hollon SD, Dennis CL, Berenbaum TS, Krohn HA, Gibori JE, Charlebois J, Clark DM, Dalfen AK, Davis W, Gaynes BN, Leszcz M, Katz SR, Murphy KE, Naslund JA, Reyes-Rodriguez ML, Stuebe AM, Zlobin C, Mulsant BH, Patel V, Meltzer-Brody S. Task-sharing and telemedicine delivery of psychotherapy to treat perinatal depression: a pragmatic, noninferiority randomized trial. Nat Med. 2025 Apr;31(4):1214-1224. doi: 10.1038/s41591-024-03482-w. Epub 2025 Mar 3.
- Derived from this study: PubMed 36174135Singla DR, Hossain S, Andrejek N, Cohen MJ, Dennis CL, Kim J, La Porte L, Meltzer-Brody SE, Puerto Nino A, Ravitz P, Schoueri-Mychasiw N, Silver R, Vigod SN, Zibaman M, Schiller CE. Culturally sensitive psychotherapy for perinatal women: A mixed methods study. J Consult Clin Psychol. 2022 Oct;90(10):770-786. doi: 10.1037/ccp0000754. Epub 2022 Sep 29.
- 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.
Daisy R Singla, PhD principal investigator
Sinai Health System
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Behavioral Activation Treatment in people with Perinatal Depression, run by Mount Sinai Hospital, Canada at 5 sites in 2 countries.
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 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 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada, 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 14 Aug 2025). 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?
Depressive Symptoms: Edinburgh Postnatal Depression Scale (EPDS) Mean Score (time frame: 3-months post-randomization). 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 NCT04153864, which also lists 13 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 14 Aug 2025.