ISRCTN11284870已完成未知
Cluster randomised trial to evaluate an integrated behavioural activation and parenting intervention for depressed HIV-positive women in the perinatal period, to enhance child cognitive development at 24 months of age and reduce maternal depression at 12 months postnatal
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 320
研究概览
简要总结
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39097310/ (added 09/08/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Current inclusion criteria as of 14/12/2022:
- •1. Pregnant women, 23-33 weeks gestation at the time of enrolment
- •2. Participant is willing and able to give informed consent for participation in the trial
- •3. Aged 16 years and above
- •4. Diagnosed HIV-positive
- •5. Mother meets criteria for antenatal depression as defined by 9 and greater on the EPDS
- •6. Living, or planning to live, within the study area at the time of delivery and for at least 9 months after delivery (the intensive therapy period)
- •7. Mother conversant in isiZulu or English
- •Current inclusion criteria as of 25/01/2019 to 14/12/2022:
- •1. Pregnant women, <33 weeks gestation at time of enrolment
- •2. Participant is willing and able to give informed consent for participation in the trial
- •3. Aged 16 years and above
- •4. Diagnosed HIV-positive
- •5. Mother meets criteria for antenatal depression as defined by 9 and greater on the EPDS
- •6. Living, or planning to live, within the study area at the time of delivery and for at least 9 months after delivery (the intensive therapy period)
- •7. Mother conversant in isiZulu or English
- •Previous inclusion criteria:
- •1. Pregnant women, <33 weeks gestation at time of enrolment
- •2. Participant is willing and able to give informed consent for participation in the trial
- •3. Aged 16 years and above
- •4. Diagnosed HIV-positive
- •5. Mother meets criteria for antenatal depression as defined by 13 and greater on the EPDS
- •6. Living, or planning to live, within the study area at the time of delivery and for at least 9 months after delivery (the intensive therapy period)
- •7. Mother conversant in isiZulu or English
排除标准
- •1. Any significant disease, disorder or disability which, in the opinion of the Principal Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial. This includes hospitalisation for at least three days for severe psychiatric illness (specifically bipolar disorder, schizophrenia and any other psychoses), or a life-threatening or other serious physical illness (excluding HIV and tuberculosis)
- •2. Current suicidal ideation/thoughts with specific plans and means identified
- •3. Substance or alcohol use disorder
- •4. Currently receiving a psychological treatment for mental health problems
- •5. Participant planning to move away from the study area before 9 months postnatal
- •6. Mother not planning to cohabit with the infant
研究者
相似试验
进行中（未招募）
不适用
Autologous stem cell transplantation versus alemtuzumab, ocrelizumab, ofatumumab or cladribine in relapsing-remitting multiple sclerosisMultiple sclerosisRelapsing-remitting multiple sclerosisNervous System DiseasesISRCTN88667898Sheffield Teaching Hospitals NHS Foundation Trust198
进行中（未招募）
Unknown
A study regarding rest, recreation and spending time outdoors as support for health and well-being of young cancer survivorsISRCTN93856392Mid Sweden University150
已完成
不适用
PACT: cluster randomised controlled trial of the ‘Your Care Needs You!’ interventioCare transitionsISRCTN17062524Bradford Teaching Hospitals NHS Foundation Trust1,000
已完成
不适用
Impact and cost-effectiveness of integrated care and results-based financing intervention on adherence among pulmonary tuberculosis patients in GeorgiaISRCTN14667607Curatio International Foundation1,153
已完成
不适用
The effectiveness and cost-effectiveness of a structured health intervention for truckers (The SHIFT Study)ISRCTN10483894oughborough University382