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PRogram In Support of Moms (PRISM): a pilot group randomized controlled trial of two approaches to improving depression among perinatal women.

ABSTRACT: PURPOSE:This pilot study was designed to inform a larger effectiveness trial by: (1) assessing the feasibility of the PRogram In Support of Moms (PRISM) and our study procedures; and, (2) determining the extent to which PRISM as compared to an active comparison group, the Massachusetts Child Access Psychiatry Program (MCPAP) for Moms alone, improves depression among perinatal women. METHODS:Four practices were randomized to either PRISM or MCPAP for Moms alone, a state-wide telephonic perinatal psychiatry program. PRISM includes MCPAP for Moms plus implementation assistance with local champions, training, and implementation of office prompts and procedures to enhance depression screening, assessment and treatment. Patients with Edinburgh Postnatal Depression Scales (EPDS)???10 were recruited during pregnancy, and completed the EPDS and a structured interview at baseline and 3-12 weeks' postpartum. RESULTS:Among MCPAP for Moms alone practices, patients' (n?=?9) EPDS scores improved from 15.22 to 10.11 (p?=?0.010), whereas in PRISM practices patients' (n?=?21) EPDS scores improved from 13.57 to 6.19 (p?=?0.001); the between groups difference-of-differences was 2.27 (p?=?0.341). CONCLUSIONS:PRISM was beneficial for patients, clinicians, and support staff. Both PRISM and MCPAP for Moms alone improve depression symptom severity and the percentage of women with an EPDS >10. The improvement difference between groups was not statistically significant due to limited power associated with small sample size.

SUBMITTER: Byatt N

PROVIDER: S-EPMC5893445 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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PRogram In Support of Moms (PRISM): a pilot group randomized controlled trial of two approaches to improving depression among perinatal women.

Byatt Nancy N Moore Simas Tiffany A TA Biebel Kathleen K Sankaran Padma P Pbert Lori L Weinreb Linda L Ziedonis Douglas D Allison Jeroan J

Journal of psychosomatic obstetrics and gynaecology 20171010 4

<h4>Purpose</h4>This pilot study was designed to inform a larger effectiveness trial by: (1) assessing the feasibility of the PRogram In Support of Moms (PRISM) and our study procedures; and, (2) determining the extent to which PRISM as compared to an active comparison group, the Massachusetts Child Access Psychiatry Program (MCPAP) for Moms alone, improves depression among perinatal women.<h4>Methods</h4>Four practices were randomized to either PRISM or MCPAP for Moms alone, a state-wide teleph ...[more]

PMID: 28994626

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Project description:BackgroundPerinatal depression, the most common pregnancy complication, is associated with negative maternal-offspring outcomes. Despite existence of effective treatments, it is under-recognized and under-treated. Professional organizations recommend universal screening, yet multi-level barriers exist to ensuring effective diagnosis, treatment, and follow-up. Integrating mental health and obstetric care holds significant promise for addressing perinatal depression. The overall study goal is to compare the effectiveness of two active interventions: (1) the Massachusetts Child Psychiatry Access Program (MCPAP) for Moms, a state-wide, population-based program, and (2) the PRogram In Support of Moms (PRISM) which includes MCPAP for Moms plus a proactive, multifaceted, practice-level intervention with intensive implementation support.MethodsThis study is conducted in two phases: (1) a run-in phase which has been completed and involved practice and patient participant recruitment to demonstrate feasibility for the second phase, and (2) a cluster randomized controlled trial (RCT), which is ongoing, and will compare two active interventions 1:1 with ten Ob/Gyn practices as the unit of randomization. In phase 1, rates of depressive symptoms and other demographic and clinical features among patients were examined to inform practice randomization. Patient participants to be recruited in phase 2 will be followed longitudinally until 13 months postpartum; they will have 3-5 total study visits depending on whether their initial recruitment and interview was at 4-24 or 32-40 weeks gestation, or 1-3 months postpartum. Sampling throughout pregnancy and postpartum will ensure participants with different depressive symptom onset times. Differences in depression symptomatology and treatment participation will be compared between patient participants by intervention arm.DiscussionThis manuscript describes the full two-phase study protocol. The study design is innovative because it combines effectiveness with implementation research designs and integrates critical components of participatory action research. Our approach assesses the feasibility, acceptance, efficacy, and sustainability of integrating a stepped-care approach to perinatal depression care into ambulatory obstetric settings; an approach that is flexible and can be tailored and adapted to fit unique workflows of real-world practices.Trial registrationClinicalTrials.gov Identifier: NCT02760004, registered prospectively on May 3, 2016.

Project description:BackgroundPerinatal depression (depression during pregnancy or the first year postpartum) affects 10%-25% of perinatal individuals, with a higher risk among youths aged <25 years. The Mothers and Babies Course (MB) is an evidence-based intervention for the prevention of perinatal depression, grounded in cognitive behavioral therapy, attachment theory, and psychoeducation.ObjectiveWe developed a digital adaptation of MB (Interactive Maternal Group for Information and Emotional Support [IMAGINE]) and evaluated it in a pre-post mixed methods pilot among young perinatal people in the United States.MethodsIMAGINE was a structured digital group of up to 7 participants, with scheduled MB content and open discussion for 12 weeks, facilitated by a social worker. Scheduled content included asynchronous SMS text messages, graphics, prerecorded videos, mood polls, and optional weekly synchronous video calls. Eligible participants were pregnant or ≤80 days postpartum, aged 16 to 24 years, had access to a smartphone, spoke English, and had a Patient Health Questionnaire score <10. Participants were recruited throughout the United States from August 2020 to January 2021 through paid social media ads, in-person outreach at clinics, and respondent-driven sampling. Participants completed quantitative questionnaires at enrollment and 3 months, and qualitative interviews at 3 months. We determined uptake, acceptability (by Acceptability of Intervention Measure score), and utility (by use of cognitive behavioral therapy skills). We compared depression symptoms (by Patient Health Questionnaire score), social support (by abbreviated Social Support Behavior score), and perceived stress (by Perceived Stress Score) between enrollment and follow-up by paired 2-tailed t test.ResultsAmong 68 individuals who contacted this study, 22 were screened, 13 were eligible, and 10 enrolled, for an uptake of 76.9%. Furthermore, 4 (40%) participants were pregnant at enrollment. Participants had a median age of 17.9 (IQR 17.4-21.7) years, 6 (67%) identified as Black, 5 (56%) Latinx, and 6 (67%) using Medicaid health insurance. Further, 9 (90%) participants completed follow-up. Among these, the mean acceptability score was 4.3 out of 5 (SD 0.6) and all participants said they would recommend IMAGINE to a friend. Participants reported using a median of 7 of 11 skills (IQR 5-7 skills) at least half the days. We found no significant changes in depression symptoms, perceived stress, or social support. Qualitatively, participants reported one-to-one support from the facilitator, connection with other parents, and regular mood reflection were especially helpful aspects of the intervention. Additionally, participants reported that the intervention normalized their mental health challenges, improved their ability to manage their mood, and increased their openness to mental health care.ConclusionsThis pilot study provides promising evidence of the acceptability and utility of IMAGINE among perinatal youths. Our study's small sample size did not detect changes in clinical outcomes; our findings suggest IMAGINE warrants larger-scale evaluation.

Project description:BACKGROUND:Perinatal depression is a prevalent public health concern. Although preventive interventions exist, there is limited literature on the acceptability and appropriateness of these interventions, especially those delivered by paraprofessionals. The Mothers and Babies Program (MB) is a group-based perinatal depression preventive intervention delivered prenatally. A cluster-randomized controlled trial examined the acceptability, appropriateness, and effectiveness of MB delivered by mental health professionals compared to paraprofessional staff from home visiting programs. METHODS:The full study enrolled 874 pregnant women. Fifty-three facilitators were trained and delivered the MB intervention to women in one of seven states in the United States. Semi-structured interviews were attempted with a randomly-selected subset of the full sample of pregnant women who received the MB intervention and with all facilitators. Specifically, interviews were conducted with 88 women who received the MB group intervention (45 in the paraprofessional-led arm and 43 in the mental health professional-led arm) and 46 women who facilitated the groups (27 home visiting staff and 19 mental health professionals). Interviews were conducted over the phone in English or Spanish and audio recorded. The recordings were translated into English, as needed, and transcribed. Thematic analysis was conducted using NVIVO to identify key themes related to intervention acceptability and appropriateness. Similarities and differences between study arms were explored. RESULTS:Clients and facilitators found the MB content and group format acceptable. Challenges included maintaining group attendance, transportation issues, and managing group discussion. Overall, facilitators found the intervention appropriate for pregnant clients with some challenges presented for clients in crisis situations, experiencing housing instability, and with literacy and learning challenges. Participants provided suggestions for improvement, both for the course content and implementation. There were no significant differences found between study arms. CONCLUSIONS:Overall, clients and facilitators enjoyed MB irrespective of study arm, and facilitators found the intervention appropriate for the population. These findings add to the qualitative literature on perinatal depression preventive interventions, specifically those delivered by paraprofessionals. TRIAL REGISTRATION:This trial is registered on ClinicalTrials.gov (Initial post: December 1, 2016; identifier: NCT02979444).

Dataset Information

PRogram In Support of Moms (PRISM): a pilot group randomized controlled trial of two approaches to improving depression among perinatal women.

Publications

PRogram In Support of Moms (PRISM): a pilot group randomized controlled trial of two approaches to improving depression among perinatal women.

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