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临床试验/NCT04572659
NCT04572659已完成不适用

Comparing Different Strategies of Psychosocial Intervention in Assisted Reproduction Treatments

IVI Sevilla0 个研究点目标入组 174 人开始时间: 2015年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
174
主要终点
Depression

研究概览

简要总结

The aim of the study was to evaluate and compare different strategies of psychosocial intervention for patients undergoing IVF treatment in a private fertility clinic. Recruited patients were assigned to one of three groups: group intervention, couple intervention or no intervention (control group). Three main variables were assessed: depression, anxiety and life quality.

详细描述

A total of 87 couples have participated in this study. All couples were about to start an assisted reproduction treatment (artificial insemination or in vitro fertilization). Couples were assigned to one of three study groups: group intervention, couple intervention or no intervention (control group). Patients in the first group (group intervention) attended six group psychotherapy sessions. Patients in the second group attended six psychotherapy sessions (particular sessions in this case). The patients in the third group received no psycho-social intervention. Assignation to each group was not randomized, it depended on scheduling availability of the patients. Patients attended one session every week or 15 days. Each session lasted 90 minutes. Sessions were designed to minimize the possible negative psycho -social impact of infertility and its treatment. Different aspects were approached in these sessions including emotion expression, social coping, communication skills, emotion management in different social situations, identification of dysfunctional thoughts, cognitive restructuring, and cognitive distortions. The outcomes measured were: anxiety, depression, life quality, coping and perceived social support. These variables were assessed before ART, after ART and in a follow-up performed six months after ART. Psychological variables were assessed using different well-recognized inventories.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Childless couples
  • About to undergo an ART treatment

排除标准

  • Undergoing ART treatment when signing the informed consent of the study
  • Pregnant when signing the informed consent of the study

结局指标

主要结局

Depression

时间窗: 6 months

Beck's Depression Inventory (BDI-II) (spanish version). Scale from 1 to 40, where a higher score means a more severe depression

Anxiety

时间窗: 6 months

State-Trait Anxiety Inventory (STAI) (spanish version). Has 20 items rated on a 4-point scale. Higher scores indicate greater anxiety

Life quality

时间窗: 6 months

Fertility Quality of Life (FertiQoL) scoring (spanish version). FertiQoL consists of 36 items scored according to 5 response categories. The response scale has a range of 0 to 4. Higher scores mean higher quality of life.

次要结局

  • Coping(6 months)
  • Perceived social support (1)(6 months)
  • Perceived social support (2)(6 months)

研究者

发起方
IVI Sevilla
申办方类型
Other
责任方
Sponsor

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