Perinatal Depression
Conditions
Keywords
Depression, Anxiety, Maternal mental health, Behavioral Activation
Brief 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). 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: 1. 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. 2. 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. 3. 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. 4. 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.
Interventions
BEHAVIORALBrief Behavioral Activation Treatment
A manualized 6-8 session BA treatment delivered individually to each participant.
Sponsors
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
Mount Sinai Hospital, Canada
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Investigators and outcome assessors are independent from type of treatment delivery and allocation status.
Intervention 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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* EPDS≥10 * ≥18 years * Pregnant up to 36 weeks or 4-30 weeks postpartum * Speaks English or (US sites) Spanish
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms: Edinburgh Postnatal Depression Scale (EPDS) Mean Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms: Edinburgh Postnatal Depression Scale (EPDS) Mean Score | 6- and 12-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. |
| Anxiety Symptoms: Generalized Anxiety Disorder Scale (GAD-7) Mean Score | 3-months post-randomization | 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. |
| Child Mental Health Development | 6 to 24 months post child birth (extended due to COVID-19) | 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. |
Countries
Canada, United States
Participant flow
Recruitment details
Participants were recruited from January 2020 to October 2023 from five clinical sites (Mount Sinai Hospital, Women's College Hospital, St. Michael's Hospital, University of North Carolina and Endeavor Health).
Pre-assignment details
A total of 3,629 individuals were approached. 1,543 agreed to participate by completing the consent form and 1,512 completed a second, more detailed screening. A total of 1,230 participants were enrolled and randomized into the trial.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Telemedicine Non-Specialist The participants in this group were randomly assigned to receive Telemedicine, with a Non-Specialist provider. | 472 |
| Arm 2: In-Person Non-Specialist The participants in this group were randomly assigned to receive In-Person care, with a Non-Specialist provider | 145 |
| Arm 3: Telemedicine Specialist The participants in this group were randomly assigned to receive Telemedicine, with a Specialist provider. | 469 |
| Arm 4: In-Person Specialist The participants in this group were randomly assigned to receive In-Person care, with a Specialist provider. | 144 |
| Total | 1,230 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Did not complete 3-month follow-up assessment but continued in the trial | 28 | 10 | 26 | 8 |
| Overall Study | Lost to Follow-up | 4 | 0 | 3 | 0 |
| Overall Study | Withdrawal by Subject | 21 | 7 | 23 | 2 |
Baseline characteristics
| Characteristic | Arm 1: Telemedicine Non-Specialist | Arm 2: In-Person Non-Specialist | Arm 3: Telemedicine Specialist | Arm 4: In-Person Specialist | Total |
|---|---|---|---|---|---|
| Age, Continuous | 33.08 years STANDARD_DEVIATION 5.1 | 33.84 years STANDARD_DEVIATION 4.79 | 33.04 years STANDARD_DEVIATION 4.79 | 34.10 years STANDARD_DEVIATION 5.01 | 33.27 years STANDARD_DEVIATION 4.95 |
| Baseline EPDS | 15.63 units on a scale STANDARD_DEVIATION 3.76 | 15.68 units on a scale STANDARD_DEVIATION 3.83 | 15.96 units on a scale STANDARD_DEVIATION 3.92 | 15.72 units on a scale STANDARD_DEVIATION 3.96 | 15.77 units on a scale STANDARD_DEVIATION 3.85 |
| Baseline GAD-7 | 11.92 units on a scale STANDARD_DEVIATION 4.76 | 12.00 units on a scale STANDARD_DEVIATION 4.54 | 11.72 units on a scale STANDARD_DEVIATION 5.11 | 11.87 units on a scale STANDARD_DEVIATION 5.08 | 11.85 units on a scale STANDARD_DEVIATION 4.9 |
| Race/Ethnicity, Customized American Indian/Alaska Native | 1 Participants | 0 Participants | 3 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian | 87 Participants | 27 Participants | 73 Participants | 22 Participants | 209 Participants |
| Race/Ethnicity, Customized Black/African American | 40 Participants | 19 Participants | 46 Participants | 19 Participants | 124 Participants |
| Race/Ethnicity, Customized Hawaiian/Pacific Islander | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic (Latino/Latina) | 38 Participants | 10 Participants | 39 Participants | 14 Participants | 101 Participants |
| Race/Ethnicity, Customized Multi-race | 34 Participants | 10 Participants | 45 Participants | 11 Participants | 100 Participants |
| Race/Ethnicity, Customized Not reported | 1 Participants | 0 Participants | 3 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 15 Participants | 4 Participants | 14 Participants | 2 Participants | 35 Participants |
| Race/Ethnicity, Customized Prefer not to answer | 13 Participants | 5 Participants | 14 Participants | 2 Participants | 34 Participants |
| Race/Ethnicity, Customized White | 242 Participants | 69 Participants | 231 Participants | 72 Participants | 614 Participants |
| Sex/Gender, Customized Different Identity | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Sex/Gender, Customized Female | 441 Participants | 144 Participants | 440 Participants | 143 Participants | 1168 Participants |
| Sex/Gender, Customized Genderqueer/Gender non-confirming | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Sex/Gender, Customized Not reported | 27 Participants | 1 Participants | 28 Participants | 1 Participants | 57 Participants |
| Sex/Gender, Customized Prefer not to answer | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 472 | 0 / 145 | 0 / 469 | 0 / 144 |
| other Total, other adverse events | 1 / 472 | 0 / 145 | 0 / 469 | 1 / 144 |
| serious Total, serious adverse events | 10 / 472 | 2 / 145 | 6 / 469 | 0 / 144 |
Outcome results
Primary
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.
Time frame: 3-months post-randomization
Population: 1\. The groups shown below are non-mutually exclusive, as participants were included in two arms (as reflected in the four arms described in the Participant Flow table). This overlap occurred because the study used a 2 × 2 factorial design, in which participants simultaneously received a combination of two interventions.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Specialist | Depressive Symptoms: Edinburgh Postnatal Depression Scale (EPDS) Mean Score | 9.27 score on a scale |
| Specialist | Depressive Symptoms: Edinburgh Postnatal Depression Scale (EPDS) Mean Score | 8.91 score on a scale |
| Telemedicine | Depressive Symptoms: Edinburgh Postnatal Depression Scale (EPDS) Mean Score | 9.15 score on a scale |
| In-Person | Depressive Symptoms: Edinburgh Postnatal Depression Scale (EPDS) Mean Score | 8.92 score on a scale |
Comparison: Behavioral Activation (BA) delivered by Non-Specialists will be non-inferior to BA delivered by Specialists if the upper limit of the 95% confidence interval for the estimated mean difference in EPDS scores is less than the pre-specified 10% non-inferiority margin (NIM).p-value: <0.05t-test, 1 sided
Comparison: Behavioral Activation (BA) delivered via Telemedicine will be non-inferior to BA delivered In-Person if the upper limit of the 95% confidence interval for the estimated mean difference in EPDS scores is less than the pre-specified 13% non-inferiority margin (NIM). Please note, this presents the Intention to Treat (ITT) analysis.p-value: <0.05t-test, 1 sided
Comparison: Behavioral Activation (BA) delivered via Telemedicine will be non-inferior to BA delivered In-Person if the upper limit of the 95% confidence interval for the estimated mean difference in EPDS scores is less than the pre-specified 13% non-inferiority margin (NIM). Please note, this is per protocol analysis. Due to institutional pandemic-related restrictions, 21 participants were switched from In-Person to Telemedicine and met criteria for the per protocol analyses.p-value: <0.05t-test, 1 sided
Secondary
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.
Time frame: 3-months post-randomization
Population: 1. The groups shown below are non-mutually exclusive, as participants were included in two arms (the four arms described in the Participant Flow table). This overlap occurred because the study used a 2 × 2 factorial design, in which participants simultaneously received combinations of two interventions.~2. At 3-months post-randomization, GAD-7 data were missing for some participants; the numbers presented above reflect only those with available data and used for analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Non-Specialist | Anxiety Symptoms: Generalized Anxiety Disorder Scale (GAD-7) Mean Score | 6.44 units on a scale |
| Specialist | Anxiety Symptoms: Generalized Anxiety Disorder Scale (GAD-7) Mean Score | 6.36 units on a scale |
| Telemedicine | Anxiety Symptoms: Generalized Anxiety Disorder Scale (GAD-7) Mean Score | 6.43 units on a scale |
| In-Person | Anxiety Symptoms: Generalized Anxiety Disorder Scale (GAD-7) Mean Score | 6.29 units on a scale |
Comparison: Behavioral Activation (BA) delivered by Non-Specialists will be non-inferior to BA delivered by Specialists if the upper limit of the 95% confidence interval for the estimated mean difference in GAD-7 scores is less than the pre-specified 10% non-inferiority margin (NIM).This analysis was performed on 3-months post-randomization scores.p-value: <0.05t-test, 1 sided
Comparison: Behavioral Activation (BA) delivered via Telemedicine will be non-inferior to BA delivered In-Person if the upper limit of the 95% confidence interval for the estimated mean difference in GAD-7 scores is less than the pre-specified 13% non-inferiority margin (NIM). Please note, this presents the Intention to Treat (ITT) analysis.p-value: <0.05t-test, 1 sided
Secondary
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.
Time frame: 6 to 24 months post child birth (extended due to COVID-19)
Secondary
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.
Time frame: 6- and 12-months post-randomization