Post Partum DepressionNCT03221556
Improving Outcomes for Low-Income Mothers With Depression
A study testing Engagement-Focused Care Coordination (EFCC) and Problem Solving Education (PSE) in people with Post Partum Depression, run by Boston Medical Center at 1 site in United States.
Trial summary
This is a randomized comparative effectiveness trial to improve outcomes among pregnant and post-partum women with symptoms of depression. Both interventions under study will be based in the patient-centered medical home setting at Boston Medical Center - specifically, in prenatal clinic or in the general pediatrics… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post Partum Depression
- What is being tested?
- Engagement-Focused Care Coordination (EFCC) and Problem Solving Education (PSE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2018to 16 Jun 2020
- 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
- Woman is pregnant and receives prenatal care at BMC; or is biological mother of 0 to 18-month-old child receiving care at BMC pediatric primary care clinic
- Woman has EPDS score ≥ 10
- Woman comfortable speaking and receiving information in English or Spanish
- Woman has no current source of mental health care, defined as having no more than one mental health care appointment in the last 3 months; OR, if more than one appointment, woman has no upcoming appointment
Who cannot join
- Woman under 18 years of age
- Woman endorses suicidality
- Woman exhibits signs of psychosis or is cognitively limited*
- As part of the informed consent process, we will administer the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), which has been validated in populations of depressed and schizophrenic adults
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Outcomes for Low-Income Mothers With Depression: A Comparative Effectiveness Trial of Two Brief Interventions in the Patient-Centered Medical Home.
This is a randomized comparative effectiveness trial to improve outcomes among pregnant and post-partum women with symptoms of depression. Both interventions under study will be based in the patient-centered medical home setting at Boston Medical Center - specifically, in prenatal clinic or in the general pediatrics clinic. The study is a type 1 hybrid effectiveness-implementation trial of 230 mothers with clinically significant depressive symptomatology. Of the 230 subjects, half will receive the Engagement-Focused Care Coordination intervention; the other half will receive the Problem Solving Education intervention. Outcomes for mothers will be assessed every 2 months throughout a 12 month follow-up period. This trial is funded by a contract with PCORI, the Patient-Centered Outcomes Research Institute.
Read the detailed description
This is a type 1 hybrid effectiveness-implementation trial of 230 mothers with clinically significant depressive symptomatology being conducted at Boston Medical Center (BMC). The effectiveness component of the study (which is the trial registered on ClinicalTrials.gov) is a pragmatic, parallel group randomized trial that measures patient-reported outcomes over 12 months of follow-up. The implementation portion comprises a series of qualitative interviews to discern barriers and facilitators to intervention implementation.
The investigators will enroll 230 mothers with clinically significant depressive symptomatology according to the Edinburgh Postnatal Depression Scale (EPDS), a widely used screening instrument valid during pregnancy and in the postpartum period.
Engagement-Focused Care Coordination will be compared to Problem Solving Education (PSE). Whereas Engagement-Focused Care Coordination emphasizes referral to formal depression services following a brief engagement session, PSE offers initial depression treatment onsite, followed by referral to further care if depressive symptoms persist or worsen. Patients in both arms will have access to the same array of community-based mental health services upon referral. Both intervention arms are designed to be peer-delivered; thus, the investigators will enlist their existing team of PCMH family advocates - a group of women (approximately age-matched with our study participants) - to serve as intervention providers. To minimize contamination across comparators, this team will be divided into those trained in Engagement Interviewing and those trained in PSE.
- Conditions
- Post Partum Depression
- Being tested
- Engagement-Focused Care Coordination (EFCC), Problem Solving Education (PSE)
- Keywords
- Comparative effectiveness research, Patient-centered medical home, Shared decision-making
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engagement-Focused Care Coordination (EFCC)Behavioural
Engagement interviewing is embedded within a traditional PCMH structure using motivational interviewing and shared decision making; it explores treatment options in the context of a patient's life circumstances, and helps her work through ambivalence to receiving care. In one to two sessions, providers disclose the probable diagnosis of depression, provide psycho-education, present treatment options, and engage clients in shared decision making to determine the most appropriate referral.
Problem Solving Education (PSE)Behavioural
Problem solving sessions are one-on-one, workbook-based interactions. Sessions comprise seven sequential steps: 1-defining a problem, 2-establishing goals for problem resolution, 3-generating multiple solution alternatives, 4-Implementing decision making guidelines, 5-evaluating and choosing solutions, 6-Implementing the preferred solutions, and 7-evaluating the outcome.
| Study group | Role | What they receive |
|---|---|---|
| Engagement-Focused Care Coordination (EFCC) | Active comparator | The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services. Receives: Behavioral: Engagement-Focused Care Coordination (EFCC) |
| Problem Solving Education (PSE) | Active comparator | The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist. Receives: Behavioral: Problem Solving Education (PSE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Symptoms at 2 Months (QIDS SR-16 ≥ 11)
Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
Measured: 2 months
Depression Symptoms at 4 Months (QIDS SR-16 ≥ 11)
Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
Measured: 4 months
Depression Symptoms at 6 Months (QIDS SR-16 ≥ 11)
Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
Measured: 6 months
Depression Symptoms at 8 Months (QIDS SR-16 ≥ 11)
Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
Measured: 8 months
Depression Symptoms at 10 Months (QIDS SR-16 ≥ 11)
Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
Measured: 10 months
Depression Symptoms at 12 Months (QIDS SR-16 ≥ 11)
Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
Measured: 12 months
Secondary outcomes (18)
Anxiety Symptoms at 2 Months
Assessed by the Beck Anxiety Inventory (BAI).This scale is a 21-item self-report measure of anxiety in the past 7 days. Each item is scored 0-3 (0 = not at all; 3 = severely - it bothered me a lot), yielding a total score range of 0 to 63. The lower the score the less self-reported anxiety.
Measured: 2 months
Anxiety Symptoms at 4 Months
Assessed by the Beck Anxiety Inventory (BAI).This scale is a 21-item self-report measure of anxiety in the past 7 days. Each item is scored 0-3 (0 = not at all; 3 = severely - it bothered me a lot), yielding a total score range of 0 to 63. The lower the score the less self-reported anxiety.
Measured: 4 months
Anxiety Symptoms at 6 Months
Assessed by the Beck Anxiety Inventory (BAI).This scale is a 21-item self-report measure of anxiety in the past 7 days. Each item is scored 0-3 (0 = not at all; 3 = severely - it bothered me a lot), yielding a total score range of 0 to 63. The lower the score the less self-reported anxiety.
Measured: 6 months
Anxiety Symptoms at 8 Months
Assessed by the Beck Anxiety Inventory (BAI).This scale is a 21-item self-report measure of anxiety in the past 7 days. Each item is scored 0-3 (0 = not at all; 3 = severely - it bothered me a lot), yielding a total score range of 0 to 63. The lower the score the less self-reported anxiety.
Measured: 8 months
Anxiety Symptoms at 10 Months
Assessed by the Beck Anxiety Inventory (BAI).This scale is a 21-item self-report measure of anxiety in the past 7 days. Each item is scored 0-3 (0 = not at all; 3 = severely - it bothered me a lot), yielding a total score range of 0 to 63. The lower the score the less self-reported anxiety.
Measured: 10 months
Anxiety Symptoms at 12 Months
Assessed by the Beck Anxiety Inventory (BAI).This scale is a 21-item self-report measure of anxiety in the past 7 days. Each item is scored 0-3 (0 = not at all; 3 = severely - it bothered me a lot), yielding a total score range of 0 to 63. The lower the score the less self-reported anxiety.
Measured: 12 months
Engaged With Care at 2 Months
Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.
Measured: 2 months
Engaged With Care at 4 Months
Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.
Measured: 4 months
Engaged With Care at 6 Months
Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.
Measured: 6 months
Engaged With Care at 8 Months
Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.
Measured: 8 months
Engaged With Care at 10 Months
Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.
Measured: 10 months
Engaged With Care at 12 Months
Assessed by the Collaborative Psychiatric Epidemiology Survey (CPES). This 9-item survey records all primary, specialty, and alternative sources of care.
Measured: 12 months
Parenting Behaviors at 6 Months
Assessed by the Parenting Stress Index Short Form (PSI). This 36-item scale yields scores on three subscales - "parental distress", "parent-child dysfunctional interaction", and "difficult child" - which combine to form the total stress scale. Each item is scored 1-5 (1 = strongly agree; 5 = strongly disagree), yielding a scoring range of 36 to 180. Higher scores reflect more parent stress.
Measured: 6 months
Parenting Behaviors at 12 Months
Assessed by the Parenting Stress Index Short Form (PSI). This 36-item scale yields scores on three subscales - "parental distress", "parent-child dysfunctional interaction", and "difficult child" - which combine to form the total stress scale. Each item is scored 1-5 (1 = strongly agree; 5 = strongly disagree), yielding a scoring range of 36 to 180. Higher scores reflect more parent stress.
Measured: 12 months
Coping With Stress at 6 Months
Assessed by the Problem Focused Subscale of the Brief Coping Orientation to Problems Experienced Inventory (COPE). The overall COPE scale is a 28-item self-report measuring ways of coping with stress. Each item is scored 1-4 (1= I haven't been doing this at all; 4 = I've been doing this a lot). The Problem Focused Subscale includes 6 items focused on active coping, positive reframing, and planning. The scores for each question are added to total the subscale score, which ranges between 6-24 with lower scores indicating less problem-focused coping and higher scores indicating more problem focused coping.
Measured: 6 months
Coping With Stress at 12 Months
Assessed by the Problem Focused Subscale of the Brief COPE. The overall COPE scale is a 28-item self-report measuring ways of coping with stress. Each item is scored 1-4 (1= I haven't been doing this at all; 4 = I've been doing this a lot). The Problem Focused Subscale includes 6 items focused on active coping, positive reframing, and planning. The scores for each question are added to total the subscale score, which ranges between 6-24 with lower scores indicating less problem-focused coping and higher scores indicating more problem focused coping.
Measured: 12 months
Behavioral Activation for Depression at 6 Months
Assessed by the Behavioral Activation for Depression Scale (BADS). This 25-item self-reported measure is used to track changes weekly in the behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation. The BADS subscales include activation, avoidance/rumination, work/school impairment, and social impairment. Each item is scored 0-6 (0=not at all; 6=completely), yielding a total score range of 0 to 150. High scores indicate greater levels of activation. For all the subscores, high scores are consistent with the subscale name.
Measured: 6 months
Behavioral Activation for Depression at 12 Months
Assessed by the Behavioral Activation for Depression Scale (BADS). This 25-item self-reported measure is used to track changes weekly in the behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation. The BADS subscales include activation, avoidance/rumination, work/school impairment, and social impairment. Each item is scored 0-6 (0=not at all; 6=completely), yielding a total score range of 0 to 150. High scores indicate greater levels of activation. For all the subscores, high scores are consistent with the subscale name.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start5 Feb 2018
- Primary completion16 Jun 2020
- Study completion16 Jun 2020
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 (1)Papers the sponsor has linked to this study.
- Other trials for Post Partum DepressionStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Boston University
- Responsible party
- Sponsor
- Investigators
- Michael Silverstein, MD MPH, Study director, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221556
- Sponsor's protocol ID
- H-36434
- Other IDs
- AD-1603-34662
- Status last verified
- Sep 2024
- First submitted
- 17 Jul 2017
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the conclusion of the project study staff will create de-identified datasets and accompanying documentation (data dictionaries, annotated forms and manuals) to be used for data sharing. We will work in collaboration with the Boston University Center for Clinical Translational Epidemiology and Comparative Effectiveness Research, which has a goal of maintaining datasets and collaborating on secondary analyses of clinical trials data.
Publications
Elansary M, Kistin CJ, Antonio J, Fernandez-Pastrana I, Lee-Parritz A, Cabral H, Miller ES, Silverstein M. Effect of Immediate Referral vs a Brief Problem-solving Intervention for Screen-Detected Peripartum Depression: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2313151. doi: 10.1001/jamanetworkopen.2023.13151.
PubMed 37171819
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes for Low-Income Mothers With Depression: A Comparative Effectiveness Trial of Two Brief Interventions in the Patient-Centered Medical Home.
- ClinicalTrials.gov ID
- NCT03221556
- Acronym / sponsor ID
- H-36434
- Conditions
- Post Partum Depression
- Keywords
- Comparative effectiveness research, Patient-centered medical home, Shared decision-making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Boston University
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 16 Jun 2020 (actual)
- Study completion
- 16 Jun 2020 (actual)
- First posted
- 18 Jul 2017 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized comparative effectiveness trial to improve outcomes among pregnant and post-partum women with symptoms of depression. Both interventions under study will be based in the patient-centered medical home setting at Boston Medical Center - specifically, in prenatal clinic or in the general pediatrics clinic. The study is a type 1 hybrid effectiveness-implementation trial of 230 mothers with clinically significant depressive symptomatology. Of the 230 subjects, half will receive the Engagement-Focused Care Coordination intervention; the other half will receive the Problem Solving Education intervention. Outcomes for mothers will be assessed every 2 months throughout a 12 month follow-up period. This trial is funded by a contract with PCORI, the Patient-Centered Outcomes Research Institute.
Detailed description
This is a type 1 hybrid effectiveness-implementation trial of 230 mothers with clinically significant depressive symptomatology being conducted at Boston Medical Center (BMC). The effectiveness component of the study (which is the trial registered on ClinicalTrials.gov) is a pragmatic, parallel group randomized trial that measures patient-reported outcomes over 12 months of follow-up. The implementation portion comprises a series of qualitative interviews to discern barriers and facilitators to intervention implementation.
The investigators will enroll 230 mothers with clinically significant depressive symptomatology according to the Edinburgh Postnatal Depression Scale (EPDS), a widely used screening instrument valid during pregnancy and in the postpartum period.
Engagement-Focused Care Coordination will be compared to Problem Solving Education (PSE). Whereas Engagement-Focused Care Coordination emphasizes referral to formal depression services following a brief engagement session, PSE offers initial depression treatment onsite, followed by referral to further care if depressive symptoms persist or worsen. Patients in both arms will have access to the same array of community-based mental health services upon referral. Both intervention arms are designed to be peer-delivered; thus, the investigators will enlist their existing team of PCMH family advocates - a group of women (approximately age-matched with our study participants) - to serve as intervention providers. To minimize contamination across comparators, this team will be divided into those trained in Engagement Interviewing and those trained in PSE.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Engagement-Focused Care Coordination (EFCC) | Active comparator | Behavioral: Engagement-Focused Care Coordination (EFCC)The brief intervention in Engagement-Focused Care Coordination is the Engagement Interview. In this model, providers meet one to two times with mothers who screen positive for depression, and use techniques of shared decision-making to help mothers process the results of the screen; explore treatment options; and connect with formal mental health services. Engagement-Focused Care Coordination emphasizes referral to formal mental health services. |
| Problem Solving Education (PSE) | Active comparator | Behavioral: Problem Solving Education (PSE)The brief Problem Solving Education (PSE) is a six-session cognitive-behavioral program. PSE offers immediate intervention in the PCMH, followed by referral to further treatment if symptoms persist. |
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)
- Woman is pregnant and receives prenatal care at BMC; or is biological mother of 0 to 18-month-old child receiving care at BMC pediatric primary care clinic
- Woman has EPDS score ≥ 10
- Woman comfortable speaking and receiving information in English or Spanish
- Woman has no current source of mental health care, defined as having no more than one mental health care appointment in the last 3 months; OR, if more than one appointment, woman has no upcoming appointment
Key exclusion criteria (4 listed)
- Woman under 18 years of age
- Woman endorses suicidality
- Woman exhibits signs of psychosis or is cognitively limited*
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 |
|---|---|---|
| Engagement-Focused Care Coordination (EFCC)Engagement interviewing is embedded within a traditional PCMH structure using motivational interviewing and shared decision making; it explores treatment options in the context of a patient's life circumstances, and helps her work through ambivalence to receiving care. In one to two sessions, providers disclose the probable diagnosis of depression, provide psycho-education, present treatment options, and engage clients in shared decision making to determine the most appropriate referral. | Behavioural | Engagement-Focused Care Coordination (EFCC) |
| Problem Solving Education (PSE)Problem solving sessions are one-on-one, workbook-based interactions. Sessions comprise seven sequential steps: 1-defining a problem, 2-establishing goals for problem resolution, 3-generating multiple solution alternatives, 4-Implementing decision making guidelines, 5-evaluating and choosing solutions, 6-Implementing the preferred solutions, and 7-evaluating the outcome. | Behavioural | Problem Solving Education (PSE) |
Primary outcome
Depression Symptoms at 2 Months (QIDS SR-16 ≥ 11)
Time frame: 2 months
Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
Depression Symptoms at 4 Months (QIDS SR-16 ≥ 11)
Time frame: 4 months
Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
Depression Symptoms at 6 Months (QIDS SR-16 ≥ 11)
Time frame: 6 months
Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
Depression Symptoms at 8 Months (QIDS SR-16 ≥ 11)
Time frame: 8 months
Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
Depression Symptoms at 10 Months (QIDS SR-16 ≥ 11)
Time frame: 10 months
Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
Depression Symptoms at 12 Months (QIDS SR-16 ≥ 11)
Time frame: 12 months
Assessed by the Quick Inventory of Depressive Symptoms (QIDS SR-16). This scale is a 16-item self-report measure of depressive symptoms over the past 7 days. Each item is scored 0-3 (0 = no presence of the symptom; 3 = high burden of the symptom), yielding a total score range of 0 to 27. QIDS scores ≥11 suggest moderate depression.
18 secondary outcomes
Anxiety Symptoms at 2 Months
Time frame: 2 months
Anxiety Symptoms at 4 Months
Time frame: 4 months
Anxiety Symptoms at 6 Months
Time frame: 6 months
Anxiety Symptoms at 8 Months
Time frame: 8 months
Anxiety Symptoms at 10 Months
Time frame: 10 months
Anxiety Symptoms at 12 Months
Time frame: 12 months
Engaged With Care at 2 Months
Time frame: 2 months
Engaged With Care at 4 Months
Time frame: 4 months
Engaged With Care at 6 Months
Time frame: 6 months
Engaged With Care at 8 Months
Time frame: 8 months
Engaged With Care at 10 Months
Time frame: 10 months
Engaged With Care at 12 Months
Time frame: 12 months
Parenting Behaviors at 6 Months
Time frame: 6 months
Parenting Behaviors at 12 Months
Time frame: 12 months
Coping With Stress at 6 Months
Time frame: 6 months
Coping With Stress at 12 Months
Time frame: 12 months
Behavioral Activation for Depression at 6 Months
Time frame: 6 months
Behavioral Activation for Depression at 12 Months
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37171819Elansary M, Kistin CJ, Antonio J, Fernandez-Pastrana I, Lee-Parritz A, Cabral H, Miller ES, Silverstein M. Effect of Immediate Referral vs a Brief Problem-solving Intervention for Screen-Detected Peripartum Depression: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2313151. doi: 10.1001/jamanetworkopen.2023.13151.
- Individual participant dataSharing planned: Yes. At the conclusion of the project study staff will create de-identified datasets and accompanying documentation (data dictionaries, annotated forms and manuals) to be used for data sharing. We will work in collaboration with the Boston University Center for Clinical Translational Epidemiology and Comparative Effectiveness Research, which has a goal of maintaining datasets and collaborating on secondary analyses of clinical trials data.
Related trials for Post Partum Depression
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Restoring Emotional Needs With Exogenous Ketones for Women With Postpartum Depression
Postpartum Depression (PPD)
Recruiting
Treatment With Repetitive Transcranial Magnetic Stimulation in Peripartal Depression
Depression During Pregnancy, Postpartum Depression (PPD)
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
RecruitingEarly Phase 1
A Web-based Intervention Program for Postpartum Depression
Postpartum Depression (PPD), Web-based Intervention
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.
Michael Silverstein, MD MPH study director
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Engagement-Focused Care Coordination (EFCC) and Problem Solving Education (PSE) in people with Post Partum Depression, run by Boston Medical Center 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 4 inclusion and 4 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 19 Sep 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 19 Sep 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?
Depression Symptoms at 2 Months (QIDS SR-16 ≥ 11) (time frame: 2 months). The study lists 6 primary outcomes in all. 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 NCT03221556, which also lists 1 linked publication.
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 19 Sep 2024.