Principal Investigator: Gwen Latendresse
Keywords: depression , prevention , mindfulness-based cognitive behavioral therapy Department: College of Nursing
IRB Number: 00071041 Co Investigator: Barbara  Wilson
Specialty: OB/Gyn, General
Sub Specialties: General Obstetrics
Recruitment Status: Recruiting

Contact Information

Gwen Latendresse
gwen.latendresse@nurs.utah.edu
801-587-9636

Simple Summary

Study Aims:1)Evaluate the feasibility of a modified Project UPLIFT program which includes videoconference delivery of an 8 week MBCBT course and participant engagement in online health assessment and resource/educational modules2)Evaluate measures of stress, depression and anxiety at the beginning and end of the project3)Develop recommendations for designing a randomized controlled trial of the modified UPLIFT program to be included in an R01 funding application to the NIH/NIMH or NICHD

Detailed Description

Purpose and ObjectivesThe overall purpose of this proposed pilot study is to test the feasibility, use and acceptability of a modified Project UPLIFT program, which will target and address modifiable psychosocial factors associated with maternal depression early in pregnancy and empowers pregnant women to engage in preventive measures (self-management). Study Aims:1)Evaluate the feasibility of a modified Project UPLIFT program which includes videoconference delivery of an 8 week MBCBT course and participant engagement in online health assessment and resource/educational modules2)Evaluate measures of stress, depression and anxiety at the beginning and end of the project3)Develop recommendations for designing a randomized controlled trial of the modified UPLIFT program to be included in an R01 funding application to the NIH/NIMH or NICHDMethodologyDuring the proposed pilot project, a total of 18 women will be enrolled into one of 3 groups (6 per group). Participants in all groups will have access to standard-of-care, evidence-based, educational modules and resource links via a dedicated and secure website (University of Utah Canvas platform). These online modules enable women to learn about and self-manage modifiable psychosocial and behavioral risk factors associated with maternal depression. The website offers modules in stress reduction, downloadable MBSR and MBCT practice recordings and exercises, nutrition, obesity, prenatal weight gain, physical exercise during pregnancy, and links to related online resources. These evidence-based education and resource links address topics often discussed by prenatal care providers within the context of standard prenatal care. The modules would be available online for all patients to self-select. A discussion board is also available should participants choose to interact with one another. Online “pen” names can be used to maintain anonymity.While the study participants in Group One will be provided the “standard-of-care” online modules and discussion board, participants in Group Two will also be invited to complete confidential health assessments online and will receive a one-time personalized health promotion and prevention recommendation based on the completed assessment. The assessment is adapted from the Centers for Disease Control and Prevention (CDC) Pregnancy Risk and Monitoring Survey (PRAMS)13 questions (see Appendix A for CDC PRAMS core and standard questions) and the PHQ-9 assessment for depression.14 Women who score 15 or higher on the PHQ-9 will be immediately contacted by the mental health professional involved in the study to ascertain the participant's safety and to make a referral to an appropriate mental health professional for ongoing mental health eval and treatment. The subsequent recommendations are meant to empower women to address the modifiable psychosocial and behavioral factors unique to each individual woman in a “self-management” approach. A Certified Nurse-Midwife and a Mental Health Professional (MHP), both credentialed and licensed to practice in the state of Utah, will jointly develop the recommendations and return them to the participant. The recommendations are tailored to each individual’s unique risk factors as a personalized approach to risk reduction, and then delivered to the participant via secure links within the Canvas online platform.Participants in Group Three, in addition to having access to the standard-of-care modules, will be invited to participate in the UPLIFT intervention in which group MBCT is delivered via SecureVideo, a HIPAA-compliant videoconferencing platform with capacity for multiple participants to simultaneously access the weekly one hour group sessions. Access can be achieved via webcam, computer VOIP (Voice Over Internet Protocol), electronic tablet, smartphone, or standard telephone, whichever format is available to the individual participant. The MBCT group meets for 1 hour, once weekly, for 8 weeks. A qualified and credentialed Mental Health Professional who is licensed in the state of Utah and trained specifically for delivery of the UPLIFT intervention (a program approved and funded by the CDC and provided by a clinical psychologist at Emory University) will deliver the MBCT sessions.

Inclusion Criteria

Intervention:

The study will include women 18 years of age and older who, at time of enrollment (1) have a viable pregnancy or have given birth within the previous 12 months, (2) have an Edinburgh Postnatal Depression Scale (EPDS) score of 9–20; (3) are English- or Spanish-speaking; and (4) are attending a collaborating prenatal or public health clinic associated with the University of Utah or Utah Department of Health.

Focus Groups:

Pregnant women and women up to 1 year postpartum will be recruited to participate in focus groups to collect qualitative input regarding the potential for a future videoconferencing MBCBT group intervention among Latina women at risk for perinatal depression. We plan to recruit 6 participants into each of two focus groups consisting of Latinas from our U of U study sites for a total of 12 women. These women will not participate in the MBCBT intervention.

Additionally, we will recruit pregnant and postpartum women from Public Health Clinics in rural Utah who have completed the telementalhealth intervention program to participate in separate focus groups.

Exclusion Criteria

The study will exclude women who, at time of enrollment

(1) have an EPDS score <9 or >20; and/or

(2) have a current diagnosis of a serious mental illness, such as psychosis, schizophrenia, bipolar disorder, severe depression, or suicidality.

Participant Reimbursement

$20 gift card for each of 2 questionnaires ($40 total).