Addressing Perinatal Depression in Deprived Areas of Istanbul, Turkey: a Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Change in Depression
研究概览
简要总结
In Turkey, the prevalence rate of perinatal depression has been estimated between 20%-40%, reflecting the global average of 25%. Untreated perinatal depression is of concern not only because of its effect on maternal health but also from the effect that impaired maternal role fulfilment has on the mother-infant bonding and child care and the long-term impact on the infant's physical and cognitive development. Thinking Healthy Programme (THP) is an evidence-based intervention incorporated into the World Health Organization's flagship Mental Health Gap Action Programme, tailored to the perinatal period that has been shown to be effective for depressed or stressed mothers. Turkey prioritize antenatal care, and this provides an opportunity to integrate mental health care into an existing antenatal care programme. Public hospitals operate 'antenatal pregnancy schools' where women are invited to attend 5 weekly group sessions that incorporate education about pregnancy and newborn care. We have developed an on-line group version of the Thinking Healthy Programme which has been designed to be integrated into the routine on-line antenatal pregnancy classes. The intervention has been designed so it is suitable for all women (universal) rather than depressed mothers only (targeted).
The aim of this study is to pilot this adapted on-line group intervention in selected hospitals' pregnancy schools.
The study will be a two-arm pilot individual randomised controlled trial comparing the Thinking Healthy group intervention integrated into antenatal pregnancy school classes with antenatal pregnancy school classes alone. Our sample size of 60 pregnant women (that is 30 participants in each arm of the pilot trial), who are over 18 years old, between 12-30 weeks' gestation, and intend to attend all 5 sessions of the online antenatal classes. Participants in both arms will be assessed for depression and anxiety symptoms, levels of disability, quality of sleep, perceived social support, coping skills, and relationship with partner. All one hundred and twenty women will get a detailed assessment initially and 4-6 weeks after the intervention. Some of the study participants and antenatal nurses delivering these sessions will be approached for in-depth qualitative interviews to explore the acceptability, feasibility and perceptions of the study participants' receiving the intervention sessions.
详细描述
Systematic reviews provide robust evidence that perinatal depression can be treated effectively in low to middle income countries with psychological treatments delivered by non-specialists. The intervention with the strongest demonstrated effect size is the Thinking Healthy Programme, the first psychological intervention to be incorporated into the World Health Organization's flagship Mental Health Gap Action Programme (mhGAP). Turkey prioritize antenatal care, and this provides an opportunity to integrate mental health care into an existing antenatal care programme.
Public hospitals operate 'antenatal pregnancy schools' where women are invited to attend 5 weekly group sessions that incorporate education about pregnancy and newborn care. The groups usually consist of 8-10 mothers and are run by antenatal nurses. During the COVID19 pandemic, these classes have been adapted into an on-line platform. Group interventions are less resource-intensive per person helped than individual interventions and are possibly more cost-effective. We have developed an on-line group version of the Thinking Healthy Programme which has been designed to be integrated into the routine on-line antenatal pregnancy classes. The intervention has been designed so it is suitable for all women (universal) rather than depressed mothers only (targeted).
Our objectives are to conduct a pilot/feasibility study of the on-line group intervention in a socioeconomically deprived population in Istanbul, Turkey.
The primary aim of this pilot study is not to test a specific hypothesis but to:
- test all operational elements including: the acceptability and feasibility of the intervention including training and supervision; the materials developed such as the manual, visual aids, and added activities to promote perinatal mental health and psychosocial well-being;
- test the willingness of women, and antenatal nurses to participate (recruitment rates), respond to questionnaires, and be followed up (attrition rates); and
- test the procedures for outcome measures as well as training and supervision. Quantitative methods will closely follow the procedures for a future definitive trial. The results will be used to finalise the intervention content and structure, to establish appropriate support systems, and to finalize all materials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The main outcomes will be recorded by outcome assessors blinded to treatment allocation. It will not be possible to blind antenatal nurses delivering the intervention in participating centres or the participants themselves to intervention allocation.
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnant women over 18 years between 12-30 weeks' gestation have access to internet, intend to attend all 5 sessions of the antenatal classes
排除标准
- •currently receiving any form of counselling or mental health care, who report suicidal ideation women who have a miscarriage, stillbirth or preterm birth will also be excluded from the follow-up assessment
结局指标
主要结局
Change in Depression
时间窗: Baseline and at 4-6 weeks after the intervention
Edinburgh Postnatal Depression Scale. This is a 10-item self-administered scale, each item is rated on a four-point scale, giving maximum scores of 30. A score of 13 or more is considered to be a significant case of postnatal depression, while scores of 10 to 12 represent borderline. It is developed for detection of symptoms of psychosocial distress during pregnancy and in the postnatal period.
次要结局
- Change in Anxiety(Baseline and 4-6 weeks after the intervention)
- Change in Sleep quality(Baseline and 4-6 weeks after the intervention)
- Change in Disability(Baseline and at 4-6 weeks after the intervention)
- Change in Perceived social support(Baseline and 4-6 weeks after the intervention)
- Change in Depression(Baseline and at 4-6 weeks after the intervention)
- Change in relationship with partner(Baseline and 4-6 weeks after the intervention)
- Change in Coping skills(Baseline and 4-6 weeks after the intervention)
研究者
Perran Boran
Professor of Pediatrics
Marmara University