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临床试验/NCT03837392
NCT03837392
已完成
不适用

A Pilot Study Examining the Efficacy of Brief Acceptance and Commitment Therapy (ACT) for Perinatal Anxiety

University of Iowa1 个研究点 分布在 1 个国家目标入组 30 人2020年6月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Post Partum Depression
发起方
University of Iowa
入组人数
30
试验地点
1
主要终点
Change in Inventory of Mood and Anxiety Symptoms (IMAS-R) scores from Baseline
状态
已完成
最后更新
2年前

概览

简要总结

This protocol will test the hypothesis that Acceptance and Commitment Therapy (ACT) is effective in reducing anxiety and depressive symptoms during the perinatal and postpartum periods. Participants should expect their participation in the study to last 9-12 months.

详细描述

The study's major theme is "to examine the efficacy of a brief Acceptance and Commitment Therapy (ACT) intervention in treating perinatal anxiety symptoms, as compared to a supportive control condition." The perinatal and postpartum periods are known to be a vulnerable time for the development of mental health symptomatology, with approximately 7% of women developing postpartum depression in the first three months following childbirth. One known predictor of postpartum depression is perinatal anxiety and distress. The impact of postpartum depression extends beyond the mother, whose distress and daily functioning are affected, with adverse effects on infant development and care. The need for interventions and preventive interventions has been widely indicated for over two decades. This protocol will describe two conditions, the effects of which will be contrasted to determine the efficacy of ACT in treating anxiety and depressive symptoms among perinatal women. The ACT condition will be compared to a supportive psychoeducation intervention. The effects of the intervention will be determined in terms of self-report measures (anxiety and depressive symptoms, flexibility, mindfulness, social satisfaction) and diagnostic interviews (depression, anxiety). The impact of trauma history and psychodiagnostic history will be examined as moderating factors and/or covariates in the examination of the intervention's efficacy. This protocol will test the hypothesis that ACT is effective in reducing anxiety and depressive symptoms during the perinatal and postpartum periods. Second, the investigators will examine the intergenerational impact of the intervention on the offspring via offspring birth outcomes, as reported in the electronic medical record. Finally, the investigators will explore mediators and moderators of the treatment outcomes. This work will advance the understanding of the impact of brief interventions on perinatal well-being and improve the ability to disseminate empirically supported interventions for pregnant mothers.

注册库
clinicaltrials.gov
开始日期
2020年6月1日
结束日期
2023年6月30日
最后更新
2年前
研究类型
Interventional
研究设计
Parallel
性别
Female

研究者

责任方
Principal Investigator
主要研究者

Emily Thomas

Clinical Assistant Professor

University of Iowa

入排标准

入选标准

  • Adult women (ages 18-45) who are between 18-26 weeks pregnant
  • Fluency in English
  • Ability to give informed consent and comply with study procedures (including phone and internet access)
  • Elevated GAD-7 score (10+)
  • Women must be receiving prenatal care
  • Singleton pregnancy

排除标准

  • Inability to give informed consent and comply with study procedures
  • Past/current mania, past/current psychoses (assessed with Psychosis Screening Questionnaire)
  • No therapy appointments in last 60 days (not currently in psychotherapy).

结局指标

主要结局

Change in Inventory of Mood and Anxiety Symptoms (IMAS-R) scores from Baseline

时间窗: Past 1 month

The IMAS-R provides continuous and diagnostic scores on mood, anxiety, and distress symptoms.

次要结局

  • Change in Acceptance and Action Questionnaire (AAQ-2) from Baseline(up to 12 month)
  • Change in Five Facet Mindfulness Questionnaire(up to 12 month)

研究点 (1)

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