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临床试验/NCT03969589
NCT03969589已完成不适用

Reproductive Life Planning for Women Veterans With Mental Illness

VA Office of Research and Development4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
4
主要终点
Reproductive Life Goal Behavioral Intentions

研究概览

简要总结

Women represent the fastest growing population within the VHA. Many are of reproductive age and experience mental health concerns. Women with mental illness are at greater risk for unplanned pregnancy and poor pregnancy outcomes due to factors related to mental health and mental health treatment. Similarly, mental health concerns (e.g., impact of pregnancy on mental illness, psychiatric medications and pregnancy) can affect reproductive life goals and plans. Reproductive life planning (RLP) interventions that include considerations and concerns women Veterans with mental illness face are needed. The investigators adapted existing RLP materials to create an interactive, individualized, client-centered RLP intervention designed to help women Veterans with mental illness develop a mental health-informed reproductive life plan and reproductive life goals (RLP-MH). The current study aims to determine if the RLP-MH intervention is feasible and acceptable to women Veterans and if it increases engagement in behaviors to address RLP goals.

详细描述

Many women Veterans are of reproductive age and, of those, a substantial number experience mental health concerns. Women Veterans with mental illness are at greater risk for unplanned pregnancy and adverse pregnancy outcomes due to factors unique to mental illness and mental health treatment. In addition, mental health and mental health-related concerns associated with pregnancy (e.g. impact of pregnancy on mental health, psychiatric medication use during pregnancy) often affect reproductive life decisions and health outcomes. For these reasons, reproductive life planning (RLP), setting personal goals and plans regarding reproductive intentions, that incorporates considerations and addresses concerns specific to mental health conditions is particularly important for women with mental illness. Despite this need, women Veterans with mental illness rarely receive RLP, and current tools do not adequately consider or address the unique reproductive health considerations women with mental illness often experience.

The investigators adapted existing RLP materials to create an interactive, client-centered RLP intervention specifically designed to address mental health considerations that can influence RLP decisions and outcomes in women Veterans with mental illness. Women Veterans work with a facilitator to explore pregnancy intentions and RLP goals; consider important factors that impact those goals (e.g. medical, mental health or psychosocial concerns); and identify steps to address their RLP goals. As such, the RLP-MH intervention may empower women Veterans with mental illness to take an active role in their reproductive health and engage in behaviors that may improve reproductive outcomes. The goal of the proposed study is to pilot-test the RLP-MH intervention in women Veterans with mental illness to evaluate its feasibility and acceptability, and to explore its potential efficacy compared to provision of written materials on RLP (control condition).

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)

盲法说明

Assessors are blind to participant condition

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • chart diagnosis of:
  • schizophrenia
  • schizoaffective disorder
  • bipolar disorder
  • major depression
  • current receiving mental health services at one of the recruitment sites

排除标准

  • currently pregnant
  • inability to have children
  • e.g. infertility, hysterectomy, tubal ligation

结局指标

主要结局

Reproductive Life Goal Behavioral Intentions

时间窗: Baseline to 2-Month Post-Intervention (~2 months)

The Reproductive Life Goal Behavioral Intentions scale was used to measure self-reported intentions to engage in behavior to address one's reproductive life goals. A total score was calculated by taking the sum of the responses to the items. The average total score across participants is reported (range = 1 to 5) with higher scores indicating greater intentions to engage in behaviors to address one's reproductive life goals.

Reproductive Health Decisional Self-Efficacy

时间窗: Baseline to 2-Month Post-Intervention (~2 months)

The Reproductive Health Decisional Self-Efficacy scale was used to measures expectations or beliefs about one's ability to engage in behaviors that help in making reproductive life decisions. A total score is calculated by taking the sum of response to the items (range = 0 to 44) with higher scores indicating greater decisional self-efficacy.

Attitudes Towards Reproductive Life Planning

时间窗: Baseline to 2-Month Post-Intervention (~2 months)

The Attitudes Towards Reproductive Life Planning developed for this study will be used to measure attitudes towards reproductive life planning and goal setting across several domains key to effective reproductive life planning. A total score is calculated by taking the sum of responses to the items (range = 7 to 49) with higher scores indicating more positive/favorable attitudes towards reproductive life planning.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (4)

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