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临床试验/NCT02310529
NCT02310529已完成不适用

Randomized Control Trial of an Interpersonal Psychotherapy for Maternal Depression

Pakistan Institute of Living and Learning4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
4
主要终点
Edinberg Postnatal Depression Scale (EPDS) To test the feasibility and acceptability of interpersonal psychotherapy in women suffering from postnatal depression.

研究概览

简要总结

Depression related to pregnancy frequently presents postpartum depression, which has deteriorating and lasting negative effects, not only on infant and child well being but also on mother's and father's mental health (Nancy K et al 2009). It is therefore important to introduce interventions aiming to improve mental health of mothers that could minimize the risk of diseases, and have positive effect child's on physical and psychological developmental wellbeing.

Therefore, this project has been designed to assess the effectiveness of Interpersonal Psychotherapy for Postnatal Depression in Pakistan.

详细描述

Prevalence of depression in the postnatal period is 10% to 17 % in western world ( O 'Hara and Swain 1996; Josseffson et al 2001; Yoshida et al 2001) and 23% to 36% in the developing world (Rahman et al 2003; Patel et al 2002; Husain et al 2006).

In developed countries, studies indicate that maternal depression is associated with long-term emotional, cognitive and behavioral problem in children. There is evidence of link between maternal psychopathology to physical health of child. Research evidence also indicates that long-term negative impact of postnatal depression is on the mother's mental health, on infant's development and on the marital relationship (Reay, Fisher, Robertson, Adams and Owen 2005).

because of high prevalence of maternal depression in low income countries like Pakistan, the present study is designed to test the effectiveness of Interpersonal Psychotherapy for women with maternal depression. The participants will be recruited from Civil hospital Karachi and also from three different communities. total 50 participants will be recruited and randomized to 2 groups: either intervention or TAU group. Assessment will be done on baseline, after completion of intervention and 3 months after completion of intervention. Assessment will include Edinburg Postnatal depression scale, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7 and Rosenberg Self Esteem scale. Participants in intervention group will receive 12 sessions of Interpersonal Psychotherapy (IPT)

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Mothers age 18 years and above older with child below 3 years of age
  • •Meet the criteria for mild to moderate depressive symptoms on (EPDS (cut off score above 10) and
  • •Were resident of trial catchment area were included in the study.

排除标准

  • •Mothers who were suffering from severe depression, with diagnosed learning or physical disability or
  • •Any major psychiatric illness other than maternal depression, with Alcohol and substance dependent or
  • •Actively suicidal were excluded from the study.

研究组 & 干预措施

Interpersonal Psychotherapy

Experimental

Interpersonal Psychotherapy will be delivered to Intervention group. The intervention group will be further divided into 3 groups (8 depressed mothers in each group). IPT is 12-16 week treatment, contains a supportive element, an educational element, parenting element and an interpersonal relationship element. Its goals include helping mothers feel supportive, empowered and confident about their parenting abilities, which will directly influence in reducing their depressive symptoms as well as resolution of interpersonal conflicts. Groups will assist people who have become withdrawn, isolated and disconnected. Intervention will be delivered by trained clinical psychologists.

干预措施: Interpersonal Psychotherapy (Behavioral)

Treatment as usual

No Intervention

Patients including in this group will be taking only treatment as usual (in Pakistan it means that participants attending in outpatients' clinic at regular intervals and may or may not be taking prescribed medication).

结局指标

主要结局

Edinberg Postnatal Depression Scale (EPDS) To test the feasibility and acceptability of interpersonal psychotherapy in women suffering from postnatal depression.

时间窗: 3 months

EPDS will be used to assess depression

次要结局

  • Generalized Anxiety Disorder-7 (GAD-7)(3 and 6 Months)
  • Rosenberg Self Esteem Scale (RSES)(3 and 6 Months)
  • Patient Health Questionnaire-9 (PHQ-9)(3 and 6 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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