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临床试验/NCT04193514
NCT04193514已完成不适用

Brief Acceptance-based Therapy for Pregnant Women With High-risk Pregnancy

Southern Methodist University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年11月15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
60
试验地点
2
主要终点
Positive and Negative Affect Schedule (PANAS)

研究概览

简要总结

This study is designed to reduce the psychological distress of women with high-risk pregnancy. Women who express interest and are eligible will have the opportunity to participate in a 7-day acceptance therapy. This therapy is based on the theory that attempts to control internal states, thoughts and feelings can contribute to symptoms of depression, anxiety and/or stress. This study aims to educate women about how the willingness to experience uncomfortable pregnancy-related sensations and thoughts, rather than fighting them, can provide relief. The therapy is completed virtually, with the first therapy session done over video call with the therapist. Following, participants complete the remaining six days of therapy on their own using a work book. All women participating in the study will be asked to complete a series of self-report questionnaires before, during, and immediately following treatment, as well as twice postpartum. Participants will receive up to $60 and a work book for participation.

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
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

  • Pregnant women with a current high-risk pregnancy.
  • Patients must be willing to engage in brief Acceptance-Commitment Therapy
  • Patients must be English-speaking.
  • Ages 18 years or older.

排除标准

  • Active suicidal ideation or self-harm in the past year; any previous history of suicide attempts.
  • History of bipolar disorder, psychosis, mental retardation or organic brain damage.
  • Currently using substances (alcohol, nicotine, marijuana, etc.)
  • Actively participating in psychotherapy for emotional or psychological problems from another provider

结局指标

主要结局

Positive and Negative Affect Schedule (PANAS)

时间窗: 1 week

The PANAS is a 20-item self-report measure for positive and negative affect. Answers range from 1 (very slightly/not al all) to 5 (extremely).

次要结局

  • Depression Anxiety Stress Scale (DASS-21)(1 week)
  • Edinburgh Postnatal Depression Scale (EPDS)(1 week)

研究者

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

Heather McClary

Director of Research Compliance

Southern Methodist University

研究点 (2)

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