Clinical and Cost-effectiveness of Learning Through Play Plus Culturally Adapted Cognitive Behaviour Therapy for Postnatal Depression in Nigeria
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 432
- 主要终点
- Change in postnatal depression is being assessed
研究概览
简要总结
Background: We aim to examine the effectiveness of Learning Through Play and Cognitive Behaviour Therapy (LTP+CaCBT), a culturally appropriate psychosocial intervention to address postnatal depression among Nigerian women and improve the well-being of their children. Women of reproductive age (ages 16 to 49) comprise about 60 million of Nigeria's 230 million people. About 30% of these mothers experience postnatal depression. The global health challenge our research addresses is that one in three women worldwide experience postnatal depression and suicidal thoughts after childbirth, with long-term negative consequences on their children and families. Since 30% of Nigerian mothers suffer from postnatal depression, they have significant risks of transferring intergenerational mental health problems to their children. Over 250 million children are at risk of lacking developmental support in low- or middle-income countries, including Nigeria, due to postnatal depression, and this limits the children from reaching their full potential in life. The treatment gap for postnatal depression in Nigeria is huge due to a shortage of mental health specialists. Culturally appropriate, nonspecialist-delivered interventions are very limited in Nigeria. Our proposal aims to address this gap in treating postnatal depression using non-specialists called Indigenous Community Health Workers (CHWs), who are more culturally knowledgeable, as the World Health Organisation recommended in their task-shifting strategy.
Methods: We will evaluate the treatment, costs and implementation outcomes of LTP+CaCBT with 432 depressed mothers. Eligible participants (mother-child pairs) will be randomly selected to receive LTP+CaCBT and Treatment As Usual (TAU) or TAU alone. Our LTP+CaCBT intervention is a manualised 12-session (90-minute each) of mother-child play activities delivered in-person by CHWs under the supervision of clinical psychologists/psychiatrists. The eligible mothers (aged 16-49 years who have children between ages 0-36 months) will be assessed for depression before the intervention and then again at 4 months and 6 months afterwards. We will conduct interviews and focus group discussions to understand participants' and CHWs' experiences of the intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years and above
- •A mother with a child (0-3 years)
- •Able to provide full consent for their participation
- •A resident of the trial catchment areas
- •Able to complete a baseline assessment
- •Score 5 or above on Patient Health Questionnaire (PHQ-9)
- •available for follow-up at 4 and 6 months post-enrolment
排除标准
- •Less than 18 years
- •Medical disorder that would prevent participation in a clinical trial, such as Tuberculosis or heart failure
- •Temporary residents are unlikely to be available for follow-up
- •Active suicidal ideation or any other severe mental disorder
- •Patients currently undergoing severe mental health treatment
- •Non-residents of the trial environs
- •Unable to consent
- •Unable to speak and understand English language
- •Other significant physical or learning disability
研究组 & 干预措施
LTP+CaCBT and TAU
The LTP+CaCBT comprises 12 in-person sessions (90 minutes each) of intervention, which is the recommended duration for psychological interventions. LTP+CaCBT is manualised, and sessions will be delivered 'in-person' by non-specialist Community Health Workers (CHWs) in Nigeria. The CHWs will be trained to deliver the LTP+CaCBT under the supervision of Nigerian clinical psychologists and psychiatrists on a weekly basis. The proposed project adopts the World Health Organisation's (WHO) recommendations of task-shifting strategies to use non-specialists to tackle shortages of culturally knowledgeable mental health workforce in LMiCs, hence using CHWs.
The experimental group will also receive Treatment As Usual (TAU). This includes participating services' regular treatment routine for postnatal depression. This is a standard patient care pathway, such as the service providers' routine assessment, management, and antidepressant prescriptions.
干预措施: Learning Through Play plus Culturally adapted Cognitive Behaviour Therapy (LTP+CaCBT) (Behavioral)
LTP+CaCBT and TAU
The LTP+CaCBT comprises 12 in-person sessions (90 minutes each) of intervention, which is the recommended duration for psychological interventions. LTP+CaCBT is manualised, and sessions will be delivered 'in-person' by non-specialist Community Health Workers (CHWs) in Nigeria. The CHWs will be trained to deliver the LTP+CaCBT under the supervision of Nigerian clinical psychologists and psychiatrists on a weekly basis. The proposed project adopts the World Health Organisation's (WHO) recommendations of task-shifting strategies to use non-specialists to tackle shortages of culturally knowledgeable mental health workforce in LMiCs, hence using CHWs.
The experimental group will also receive Treatment As Usual (TAU). This includes participating services' regular treatment routine for postnatal depression. This is a standard patient care pathway, such as the service providers' routine assessment, management, and antidepressant prescriptions.
干预措施: Treatment as Usual (TAU) (Drug)
TAU alone
Treatment As Usual (TAU) alone group will receive the participating services' regular treatment routine for postnatal depression. This is a standard patient care pathway, such as the service providers' routine assessment, management, and antidepressant prescriptions which is entirely different from LTP+CaCBT.
干预措施: Treatment as Usual (TAU) (Drug)
结局指标
主要结局
Change in postnatal depression is being assessed
时间窗: Change is being assessed from baseline, end of intervention at 4 and at 6 months post-intervention
Primary outcome measure would be assessed using the Patient Health Questionnaire (PHQ-9)
次要结局
- Change in child physio-emotional development is being assessed(Change is being assessed from baseline, end of intervention at 4 and 6 months post-intervention)
- Change in mother-child attachedment is being assessed(Change is being assessed from baseline, end of intervention at 4 and 6 months post-intervention)
- Change in postnatal anxiety is being assessed(Change is being assessed from baseline, end of intervention at 4 and at 6 months post-intervention)
- Change in health-related quality of life is being assessed(Change is being assessed from baseline, end of intervention at 4 and at 6 months post-intervention)
- Change in social support is being assessed(Change is being assessed from baseline, end of intervention at 4 and 6 months post-intervention)
- Change in service satisfaction is being assessed(Change is being assessed at end of intervention at 4 months post-intervention)
研究者
Dr Dung Jidong, PhD
Dr
University of Manchester