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临床试验/CTRI/2025/11/097899
CTRI/2025/11/097899尚未招募不适用

Integrated Grief Therapy for Women Survivors Of Perinatal Loss A Feasibility study

National Institute of Mental Health and Neurosciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年2月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1

研究概览

简要总结

The current study aims to examine the feasibility and effectiveness of integrated grief therapy on mental health and meaning making for women survivors of perinatal loss. It will utilize a single group, pre-mid-post-follow-up design with two phases; formative and therapy phase.

The sample; women between 19 and 45 years of age, who have experienced perinatal loss in the past 12 months, will be recruited from the perinatal psychiatry services at NIMHANS, an obstetrics and gynecology (OBG) specialty hospital in Bengaluru, and from appropriate online social media platforms.

In the formative phase, women, n=5 who have survived perinatal loss will be interviewed. Themes from the interviews will be combined with a detailed literature review to compile and adapt the proposed integrated grief therapy, which will be validated by experts, n=5 in the field of perinatal medical and mental health, women’s mental health or grief therapy. In the therapy phase, a sample of n=30 consenting women who meet the inclusion criteria will be enrolled for integrated grief therapy, which includes 8 weekly individual sessions and 1 elective session for the spouse.

Select study measures will be administered at different time points; baseline, mid-intervention (after 4 sessions), post intervention, and follow-up after 8- 10 weeks. Study measures include Kessler Psychological Distress Scale (K-10) for screening, antecedent measures include Adverse Childhood Experiences Questionnaire (ACE-Q), Experiences in Close Relationships Scale– Short form (ECR-S), Dyadic Adjustment Scale-7 (DAS-7), and Social Provisions Scale-5 (SPS-5), outcome measures include Perinatal Grief Scale (PGS), WHO-5 Well-being scale (WHO-5), Grief and Meaning Reconstruction Inventory (GMRI), Helpful Aspects of Therapy form as a measure of therapy process, and a measure of feasibility which is to be developed.

The findings from the feasibility study could help in planning future controlled trials and also have important clinical implications for improving psychotherapy services in diverse settings for women and couples who have survived perinatal loss.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
19.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Women who score above 20 on Kessler Psychological Distress scale following perinatal loss, indicating clinically significant level of psychological distress.
  • Women who have experienced perinatal loss in the past 12 months.
  • Primiparous or multiparous women.
  • Women who are married.
  • Women who are fluent in speaking English or Tamil.

排除标准

  • Women who are acutely physically or psychologically distressed and unable to engage in assessment or psychotherapy.
  • Women with a history of perinatal loss who are currently pregnant.
  • Women diagnosed with severe mental health disorders like severe depression, bipolar affective disorder, severe suicidal risk and affective and non-affective psychosis.
  • Women identified with intellectual difficulties on clinical examination.
  • Women with neurological or organic brain conditions.
  • Women who are currently receiving therapy for perinatal grief.

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Ashwathi PG

National Institute of Mental Health and Neurosciences

研究点 (1)

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