Dataset Information

Delivering the Thinking Healthy Programme as a universal group intervention integrated into routine antenatal care: a randomized-controlled pilot study.

ABSTRACT:

Background

Women with perinatal depression and their children are at increased risk of poor health outcomes. There is a need to implement non-stigmatizing interventions into existing health systems which reduce psychosocial distress during pregnancy and prevent perinatal depression. We adapted the WHO-endorsed Thinking Healthy Programme (THP) to be delivered universally to all women attending routine online pregnancy schools in Istanbul, Turkey. This study aimed to evaluate the feasibility and acceptability of this intervention.

Methods

This mixed-methods study incorporated a two-arm pilot randomized controlled trial and qualitative evaluation of the feasibility and acceptability of the adapted THP - Brief Group version (THP-BGV) to a range of stakeholders. We recruited pregnant women at 12-30 weeks' gestation through pregnancy schools within the University Hospital's catchment area. Women in the intervention arm received five online sessions of the THP-BGV delivered by antenatal nurses. The intervention employed principles of cognitive behaviour therapy to provide psychoeducation, behaviour activation, problem-solving strategies and group support to participants. In the control arm, women received usual care consisting of routine online educational pregnancy classes aided by the antenatal nurses. The women were assessed for depressive symptoms with the Edinburgh Postnatal Depression Scale at baseline and 4-6 weeks post-intervention and also evaluated for anxiety, perceived social support, partner relationship, level of disability and sleep quality. In-depth interviews were conducted with women and other key stakeholders.

Results

Of the 99 consecutive women referred to the pregnancy schools, 91 (91.9%) were eligible and 88 (88.8%) consented to participate in the study and were randomized. Eighty-two (83%) completed the final assessments. Our main findings were that this preventive group intervention was feasible to be integrated into routine antenatal educational classes and it was valued by the women and delivery-agents. While the study was not powered to detect differences between intervention and control conditions, we found small trends towards reduction in anxiety and depressive symptoms favoring the intervention arm. No serious adverse events were reported.

Conclusions

Given the paucity of preventive interventions for perinatal depression in low and middle-income countries, a fully powered definitive randomized controlled trial of this feasible and acceptable intervention should be conducted.

Trial registration

The study was registered at Clinical Trails.gov ( NCT04819711 ) (Registration Date: 29/03/2021).

SUBMITTER: Boran P

PROVIDER: S-EPMC9816542 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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Publications

Delivering the Thinking Healthy Programme as a universal group intervention integrated into routine antenatal care: a randomized-controlled pilot study.

Boran Perran P Dönmez Melike M Barış Ezgi E Us Mahmut Caner MC Altaş Zeynep Meva ZM Nisar Anum A Atif Najia N Sikander Siham S Hıdıroğlu Seyhan S Save Dilşad D Rahman Atif A

BMC psychiatry 20230106 1

<h4>Background</h4>Women with perinatal depression and their children are at increased risk of poor health outcomes. There is a need to implement non-stigmatizing interventions into existing health systems which reduce psychosocial distress during pregnancy and prevent perinatal depression. We adapted the WHO-endorsed Thinking Healthy Programme (THP) to be delivered universally to all women attending routine online pregnancy schools in Istanbul, Turkey. This study aimed to evaluate the feasibili ...[more]

PMID: 36604685

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Project description:BackgroundWomen with perinatal depression and their children are at increased risk of poor health outcomes. Integrating evidence based non-stigmatizing interventions within existing health systems is crucial to reducing psychosocial distress during pregnancy and preventing perinatal depression. This study aimed to evaluate the feasibility of the World Health Organization (WHO) endorsed cognitive-behavior therapy-based Thinking Healthy Programme (THP), delivered by antenatal nurses in China.MethodsA two-arm pilot randomized controlled pilot trial was conducted to assess the feasibility and of the adapted Chinese version of the Thinking Healthy Programme (THP) among various stakeholders. We recruited pregnant women between 25- and 34-weeks' gestation from two pregnancy schools within the two public sector Hospitals in Xian. Participants in the intervention group attended five face to face sessions of THP facilitated by antenatal nurses. This intervention used cognitive behavior therapy principles to offer psychoeducation, behavioral activation, problem-solving strategies, and social support. In the control group, participants received standard care, which included routine pregnancy education classes led by antenatal nurses. We assessed depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9) at baseline, after the intervention and 4-6 weeks post-intervention, along with evaluations of anxiety, perceived social support, and health-related quality of life.ResultsAmong the 737 pregnant women screened, 267 (30.26%) scored ≥5 on the PHQ-9. Out of these, 85 were eligible and consented to participate, with 42 assigned to the intervention group and 43 to the control group. Eighty participants (94.1%) completed the final assessments. Our primary findings indicated that this nurse-delivered intervention was feasible to integrate into routine antenatal care and was well-received by both the women and the delivery agents. Although the study was not designed to detect differences between the intervention and control groups, we observed positive trends towards reductions in anxiety and depressive symptoms favoring the intervention arm. No serious adverse events were reported. This trial is registered in the Chinese Clinical Trial Registry with the registration number ChiCTR1900028114.ConclusionsWe conclude that this intervention, grounded in the well-established WHO Thinking Healthy Programme, is both feasible and acceptable to stakeholders. It merits a definitive randomized trial to assess its effectiveness and cost-effectiveness across various settings.Clinical trial registrationChiCTR1900028114.

Project description:Optimal maternal nutrition, including adequate intake and status of essential micronutrients, is important for the health of women and developing infants. Currently, the World Health Organization (WHO) Antenatal care recommendations for a positive pregnancy experience recommend daily iron and folic acid (IFA) supplementation as the standard of care. The use of multiple micronutrient supplements (MMS) is recommended in the context of rigorous research as more evidence was needed regarding the impact of switching from IFA supplements to MMS, including evaluation of critical clinical maternal and perinatal outcomes, acceptability, feasibility, sustainability, equity and cost-effectiveness. WHO convened a technical consultation of key stakeholders to discuss research priorities with the objective of providing guidance and clarity to donors, implementers and researchers about this recommendation. The overarching principles of the research agenda include the use of clinical indicators and impact measures that are applicable across studies and settings and the inclusion of outcomes that are important to women. Future studies should consider using standardized protocols based on current best practices to measure critical outcomes such as gestational age (GA) and birthweight (BW) in studies. As GA and BW are influenced by multiple factors, more research is needed to understand the biological impact pathways, and how initiation and considerations for timing of MMS influence these outcomes. A set of core clinical indicators was agreed upon during the technical consultation. For implementation research, the Evidence-to-Decision framework was used as a resource for discussing components of implementation research. The implementation research questions, key indicators and performance measures will depend on country-specific context and bottlenecks that require further research and improved solutions to enable the successful implementation of iron-containing supplements.

Project description:IntroductionThe J9 Plus (J9) maternal-child accompaniment program is based on four pillars: group antenatal care (GANC), group pediatric care, psychosocial support, and community-based care. We aimed to evaluate the impact of the J9 model of care on perinatal outcomes.MethodologyWe conducted a convergent mixed methods study of maternal-newborn dyads born in 2019 at Hôpital Universitaire de Mirebalais. Quantitative data was collected retrospectively to compare dyads receiving J9 care to usual care. A secondary analysis of qualitative data described patient perspectives of J9 care.ResultsAntenatal care attendance was significantly higher among women in J9 (n = 524) compared to usual care (n = 523), with 490(93%) and 189(36%) having >4 visits, respectively; p <0.001, as was post-partum visit attendance [271(52%) compared to 84(16%), p<0.001] and use of post-partum family planning methods [98(19%) compared to 47(9%), p = 0.003]. Incidence of pre-eclampsia with severe features was significantly lower in the J9 group [44(9%)] compared to the usual care group [73(14%)], p <0.001. Maternal and neonatal mortality and low birth weight did not differ across groups. Cesarean delivery [103(20%) and 82(16%), p<0.001] and preterm birth [118 (24%)] and 80 (17%), p <0.001] were higher in the J9 group compared to usual care, respectively. In the qualitative analysis, ease of access to high-quality care, meaningful social support, and maternal empowerment through education were identified as key contributors to these outcomes.ConclusionCompared to usual care, the J9 Plus maternal-child accompaniment model of care is associated with increased engagement in antenatal and postpartum care, increased utilization of post-partum family planning, and lower incidence of pre-eclampsia with severe features, which remains a leading cause of maternal mortality in Haiti. The J9 accompaniment approach to care is an empowering model that has the potential to be replicated in similar settings to improve quality of care and outcomes globally.

Project description:Trial sponsorBangor University, Brigantia Building, College Road, Bangor, LL57 2AS, UK INTRODUCTION: The COPING parent online universal programme is a web-based parenting intervention for parents of children aged 3-8 years with an interest in positive parenting. The programme focuses on strengthening parent-child relationships and encouraging positive child behaviour. This trial will evaluate whether the intervention is effective in increasing the use of positive parenting strategies outlined in the programme using parent report and blind observation measures.Methods and analysisThis is a pilot randomised controlled trial with intervention and wait-list control conditions. The intervention is a 10-week online parenting programme to promote positive parent-child relations by teaching core social learning theory principles that encourage positive child behaviour, primarily through the use of praise and rewards. Health visitors and school nurses will circulate a recruitment poster to parents of children aged 3-8 years on their current caseloads. Recruitment posters will also be distributed via local primary schools and nurseries. Parents recruited to the trial will be randomised on a 2:1 ratio to intervention or wait-list control conditions (stratified according to child gender and age). The primary outcome measure is positive parenting as measured by a behavioural observation of parent-child interactions using the Dyadic Parent-Child Interaction Coding System. Secondary outcomes include parent report of child behaviour, and self-reported parental sense of competence, parenting behaviour and parental mental health. Data will be collected at baseline and 3 months later (postintervention) for all participants and 6 months postbaseline for the intervention group only. Analysis of covariance will be the main statistical method used.Ethics and disseminationThe trial has received ethical approval from the NHS Betsi Cadwaladr University Health Board Ethics Committee (REC) and the School of Psychology, Bangor University REC (15/WA/0463). Publication of all outcomes will be in peer-reviewed journals and conference presentations.Trial registration numberCurrent Controlled Trials ISRCTN89370147 (5 May 2016).

Project description:BackgroundPerinatal depression is highly prevalent in South Asia. Although effective and culturally feasible interventions exist, a key bottleneck for scaled-up delivery is lack of trained human resource. The aim of this study was to adapt an evidence-based intervention so that local women from the community (peers) could be trained to deliver it, and to test the adapted intervention for feasibility in India and Pakistan.MethodsThe study was conducted in Rawalpindi, Pakistan and Goa, India. To inform the adaptation process, qualitative data was collected through 7 focus groups (four in Pakistan and three in India) and 61 in-depth interviews (India only). Following adaptation, the intervention was delivered to depressed mothers (20 in Pakistan and 24 in India) for six months through 8 peers in Pakistan and nine in India. Post intervention data was collected from depressed mothers and peers through 41 in-depth interviews (29 in Pakistan and 12 in India) and eight focus groups (one in Pakistan and seven in India). Data was analysed using Framework Analysis approach.ResultsMost mothers perceived the intervention to be acceptable, useful, and viewed the peers as effective delivery-agents. The simple format using vignettes, pictures and everyday terms to describe distress made the intervention easy to understand and deliver. The peers were able to use techniques for behavioural activation with relative ease. Both the mothers and peers found that shared life-experiences and personal characteristics greatly facilitated the intervention-delivery. A minority of mothers had concerns about confidentiality and stigma related to their condition, and some peers felt the role was emotionally challenging.ConclusionsThe study demonstrates the feasibility of using peers to provide interventions for perinatal depression in two South Asian settings. Peers can be a potential resource to deliver evidence-based psychosocial interventions.Trial registrationPakistan Trial: ClinicalTrials.gov Identifier: NCT02111915 (9 April 2014), India Trial: ClinicalTrials.gov Identifier: NCT02104232 (1 April 2014).

Dataset Information

Delivering the Thinking Healthy Programme as a universal group intervention integrated into routine antenatal care: a randomized-controlled pilot study.

Background

Methods

Results

Conclusions

Trial registration

Publications

Delivering the Thinking Healthy Programme as a universal group intervention integrated into routine antenatal care: a randomized-controlled pilot study.

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