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临床试验/NCT05106959
NCT05106959已完成不适用

Piloting a Motivational Interviewing Shame-Resilience Training

University of New Mexico2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2020年6月26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
19
试验地点
2
主要终点
Willingness to Communicate

研究概览

简要总结

The purpose of this study is to evaluate the shame resilience theory in a pilot context to assess its feasibility in a potential full scale clinical trial. Shame resilience was developed through qualitative methods but currently has little quantitative backing. Continued research is needed to assess shame-resilience as a potential intervention for shame which little is known to combat prevalent negative health outcomes associated with shame.

详细描述

Shame is an emotion that can have significant negative impacts on health outcomes, including engagement in care. Feelings of shame are commonly experienced with stigmatized behaviors, such as substance misuse, and may be particularly strong among pregnant women who misuse substances. Rates of opioid misuse during pregnancy are dramatically rising, particularly in New Mexico, leading to negative health outcomes for mothers and fetuses. Shame has been found to decrease these patients' willingness to attend and engage in care. Although a theoretical model is available to guide interventions to reduce shame, it has not been tested empirically. In the current study, investigators seek to evaluate the preliminary effectiveness and feasibility of a brief Shame Resilience Intervention among women seeking care in UNM's Milagro program, a prenatal medical clinic for opioid using pregnant women. This research has the potential to significantly improve public health by generating a tool to reduce barriers to care.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Study participants will be Milagro patients
  • Engaged in medication assisted treatment
  • At least 18 years of age
  • Can read and speak English
  • Are willing to be contacted for follow-up \
  • Are not incarcerated
  • Are within the first or second trimester of pregnancy

排除标准

  • The study will not enroll non-English speaking Milagro patients
  • Patients with obvious cognitive impairments
  • Patients with the inability to provide informed consent.

结局指标

主要结局

Willingness to Communicate

时间窗: 1-month

This measure looks at participants willingness to communicate about their health on a 5 point Likert Scale; 1-5 with higher scores indicating a greater willingness to communicate. Participants respond to a series of questions on a questionnaire.

Adult Trauma Symptom Checklist

时间窗: 1-month

This measure looks at current symptoms of past trauma experiences on a 4 point Likert scale; 0-3 with higher scores indicating a greater presence of adult trauma symptoms. Participants respond to a questionnaire.

Shame Compass

时间窗: 1 month

This measure looks at the intensity and frequency of shame experiences on a 4 point Likert Scale; 0-3 with higher scores indicating a greater intensity and frequency of shame experiences. Participants respond to a questionnaire.

WHO Big 5 Subjective Well-Being

时间窗: 1-month

This measure looks at participants well-being over the past two weeks on a 6 point Likert Scale; 0-5. Scores range from a minimum of 0 to a maximum of 25, with higher scores indicating a better subjective well-being. Participants respond to a questionnaire.

Shame Resilience Amongst Mental Health Trainees

时间窗: 1-month

This measure looks at how much a participant is practicing shame resilience on a 4 point Likert Scale; 0-3 with higher scores indicating better shame resilience. Participants respond to a questionnaire.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Hettema

Associate Professor

University of New Mexico

研究点 (2)

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