Telehealth Group Intervention for Perinatal Depressive Symptoms (TePOP)
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|ClinicalTrials.gov Identifier: NCT03932760|
Recruitment Status : Not yet recruiting
First Posted : May 1, 2019
Last Update Posted : May 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Perinatal Depression||Behavioral: UPLIFT Program Behavioral: Attention Control Group||Not Applicable|
Perinatal depression (PD) affects 12-15% of women and contributes to adverse outcomes, e.g. preterm birth, low birth weight, and impaired cognitive development of the child. Screening optimizes the detection of PD, but does not reduce barriers to mental health services (MHS) encountered by women who screen positive. A known shortage of MHS across the nation is a significant barrier, particularly in low resource and rural settings. Telehealth is a promising approach to reducing barriers, but there is little research on the effectiveness of telehealth to reduce perinatal depressive symptoms (PDS). There is high potential for telehealth to deliver effective, lower cost MHS to childbearing women, particularly those in low resource settings.
The proposed project is a randomized controlled trial among women with mild to moderate PDS. The project aims to evaluate; 1) the effectiveness of a group mental health videoconference intervention (VCI) to reduce PDS across pregnancy and postpartum, and (2) differences in PDS between diverse groups of childbearing women: rural and urban-dwelling, and Latina and predominantly North European Descent (NED) populations. We hypothesize that women participating in the VCI will have significantly lower PDS across pregnancy and postpartum than women in an equivalent attention control (AC) group, and the results will differ between diverse groups. A total of 192 women will be enrolled; 48 in each study group. Participants are randomly assigned to study groups: VCI +¬¬ standard of care, or AC + standard of care. Sessions are delivered via Utah Telehealth Network (UTN). Women in both groups attend weekly one-hour group sessions for 8 weeks using any electronic device (laptop, tablet, smart phone) from their own home. PDS is measured at 3 time points in pregnancy and 3 time points in postpartum.
Our study is the first to use a VCI to engage women in a facilitated group approach to reducing PDS, and to evaluate the impact among diverse groups. The approach is cost effective and reduces barriers to access to MHS, particularly for women living in low-resource, and minority communities, and those without adequate transportation, childcare, or work release time. The VCI can be replicated in any setting (e.g. rural or urban), and can be adapted to the needs of diverse communities. The study advances the field by establishing whether a group telehealth intervention reduces PDS, and whether this differs based on the population. If effective and implemented broadly, far fewer women and families would suffer the negative consequences of depression. The proposed project is in line with NINR's high priority areas, including the use of technology to promote health, and a focus on self-management and symptom science.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||192 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||randomized controlled trial|
|Masking:||None (Open Label)|
|Official Title:||Randomized Trial of Telehealth Group Intervention to Reduce Perinatal Depressive Symptoms in Diverse Populations|
|Estimated Study Start Date :||April 22, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 15, 2021|
Experimental: UPLIFT Program
Weekly one-hour group sessions for 10 weeks facilitated by a mental health professional.
Behavioral: UPLIFT Program
UPLIFT is based on cognitive behavioral therapy and mindfulness-based practices. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.
Active Comparator: Pregnancy Skills Group
Weekly one-hour group sessions for 10 weeks facilitated by a registered nurse.
Behavioral: Attention Control Group
Program is based on standard prenatal, childbirth, infant feeding, and parenting education curriculum. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.
- Change in Depressive Symptoms Over Time [ Time Frame: Time 1 = pre-intervention; T2 = post-intervention, approximately 12 weeks after pre-intervention; T3= 35 weeks gestations; T4 = 2 months postpartum; T5 = 4 months postpartum; T6 = 6 months postpartum ]Self-completed: Edinburgh Postnatal Depression Scale measures depression symptoms during pregnancy and postpartum. The instrument will measure depressive symptoms at 6 time points during pregnancy and postpartum. The instrument is on a scale of 0-30, with 0 indicating no symptoms, and 30 indicating the highest severity of symptoms. Scores < 10 = no depressive symptoms; 10-15 = mild; 16-20 = moderate; > 20 = severe.
- Change in Anxiety Symptoms Over Time [ Time Frame: Time 1 = pre-intervention; T2 = post-intervention, approximately 12 weeks after pre-intervention; T3= 35 weeks gestations; T4 = 2 months postpartum; T5 = 4 months postpartum; T6 = 6 months postpartum ]Self-completed: Generalized Anxiety Disorder - 7 Item scale measures symptoms of anxiety. The instrument will measures anxiety symptoms at 6 time points during pregnancy and postpartum. The instrument is on a scale of 0-21, with 0 indicating no symptoms, and 21 indicating the highest severity of symptoms. Scores of < 5 = no anxiety; 5-9 = mild; 10-14 = moderate; > 15 = severe.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03932760
|Contact: Susan Dearden, MPHemail@example.com|
|Contact: Ryoko Pentecost, BSN, MSfirstname.lastname@example.org|
|Principal Investigator:||Gwen Latendresse, PhD||University of Utah|