No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
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At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Supportive Care
Participants needed
120 (estimated)
Sponsor
University of Utah · Other
Who this trial is looking for
This trial is looking for pregnant and postpartum women at risk for depression. Participants will engage in a remote mindfulness program linked to their healthcare that aims to help improve their mental health.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old
I am currently pregnant or have given birth within the last year
I am identified as at-risk for postpartum depression
I speak English or Spanish
I attend a UHealth clinic or a rural public health partner clinic
You may not be able to join if
I have a substance use disorder
I have a serious mental illness like psychosis or bipolar disorder
I have severe depression or anxiety
I have thoughts of harming myself
I am currently taking any medications for a mental health condition
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This hybrid effectiveness-implementation project will allow the team to evaluate and refine implementation in preparation for future multisite trials to ultimately move the Evidence-Based Intervention (EBI) to scale among diverse populations. The plan is to enroll 120 at-risk pregnant and postpartum women from rural, urban, and Latino populations. Using a randomized preference design to also evalu…
This hybrid effectiveness-implementation project will allow the team to evaluate and refine implementation in preparation for future multisite trials to ultimately move the Evidence-Based Intervention (EBI) to scale among diverse populations. The plan is to enroll 120 at-risk pregnant and postpartum women from rural, urban, and Latino populations. Using a randomized preference design to also evaluate patient and sociocultural factors in participation and symptom trajectory.
Using the Implementation Research Logic Model, the team will evaluate the implementation feasibility and acceptability of a remote-access and on-demand MBCT PD prevention intervention that is integrated within maternal clinical care settings using an existing patient portal. Successful achievement of the study aims will result in a refined implementation protocol for future studies that are sufficiently powered to evaluate the effectiveness of an integrated Digital Mental Health Technology and to estimate the cost/benefit ratio
Trial Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
* 18+ years of age, who at the time of screening
* Have a viable pregnancy or are postpartum (up to 1 year)
* Identified as at-risk for PD (any one of the following:
* EPDS score equal to or greater than 9 or less than 21
* History of depression/anxiety
* 2 or more significant l…
Inclusion Criteria:
* 18+ years of age, who at the time of screening
* Have a viable pregnancy or are postpartum (up to 1 year)
* Identified as at-risk for PD (any one of the following:
* EPDS score equal to or greater than 9 or less than 21
* History of depression/anxiety
* 2 or more significant life events)
* English- or Spanish-speaking
* Currently attending a UHealth clinic or rural public health partner clinic.
Exclusion Criteria:
* Have a substance use disorder
* Current diagnosis of serious mental illness, such as psychosis, schizophrenia, bipolar disorder, severe depression (including EPDS \> 20)
* Severe anxiety, suicidality, or currently taking any medications for a mental health condition.
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