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临床试验/CTRI/2025/05/086655
CTRI/2025/05/086655尚未招募不适用

Couple-Centred Brief Intervention (CCBI) for Common Perinatal Mental Disorders among Parental Dyads during First Year of Child Birth: A Parallel Group, Non-Inferiority Trial

NIMHANS1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
NIMHANS
入组人数
260
试验地点
1
主要终点
Reduction in depression and/or anxiety scores among participants

研究概览

简要总结

Common perinatal mental disorders CPMD like postpartum depression PPD and postpartum anxiety PPA are significant mental health concerns. They not only impact individual well-being but also strain the parental relationship. Interventions for CPMD focus solely on individual treatments, overlooking the systemic nature of the problem within the parental unit. Thus, there is a need for interventions tailored to parental dyads that address both individual and relational factors. There have been no studies focusing on the effectiveness of interventions targeting both the postpartum woman and her partner for CPMD.

This study investigates whether such an intervention will be effective in community settings. Moreover, it will facilitate brief mental health screening of postnatal women, which is a part of postnatal care yet not fully implemented, as per field experiences. Therefore, this study is carried out to investigate the effectiveness of a Couple-Centred Brief Intervention CCBI for mild to moderate PPD and PPA among parental dyads during the first year of childbirth, when compared to standard care treatment recommended by healthcare providers.

This is a randomized controlled trial with two parallel arms, CCBI and Standard Care. Parental dyads will be screened sequentially using the Patient Health Questionnaire PHQ-2, PHQ-9 and the Generalized Anxiety Disorder scales GAD-2 and GAD-7. Either member of the parental dyad with a PHQ-9 score between 10 and 19 or a GAD-7 score between 10 and 14 will be invited to participate and randomly assigned to either the intervention or standard care group. Assessments will be conducted at baseline and at end-points four weeks after the last session of the intervention or standard care.

This trial contributes to the evidence base for interventions targeting CPMD among parental dyads. If successful, it would offer a valuable addition to existing treatment approaches.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 49.00 Year(s)(—)
性别
All

入选标准

  • parental dyad postnatal woman and her husband with woman aged 18 years and above who underwent delivery in the past year residing in the study area for more than 6 months and with a score of 10 to 19 on PHQ 9 mild to moderately severe depression and GAD 7 score 10 to 14.

排除标准

  • Those with PHQ 9 score of 19 and above severe depression and GAD 7 score of 14 and above severe anxiety.

结局指标

主要结局

Reduction in depression and/or anxiety scores among participants

时间窗: Four weeks after intervention delivery

次要结局

  • Relationship satisfaction, social support, parenting involvement, obstetric & morbidity profile(4 weeks after intervention delivery)

研究者

发起方
NIMHANS
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Pracheth R

NIMHANS Bengaluru

研究点 (1)

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