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临床试验/NCT02883686
NCT02883686已完成不适用

The Effectiveness of the Alma Peer Mentoring Program for Pregnant Women With Depression

University of Colorado, Boulder4 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2019年2月6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
27
试验地点
4
主要终点
Change in Patient Health Questionnaire (PHQ-9) score

研究概览

简要总结

Women have double the odds of getting depressed as men and commonly experience depression during the childbearing and early parenting years. Many new and expectant mothers who experience depression never receive help. Alma is a new program, collaboratively developed by a team of researchers, clinicians, and mothers who have personal experience with depression, to support women experiencing depression during pregnancy and the postpartum period. In the Alma program, mothers who themselves have experienced and recovered from depression during the perinatal period, are trained to provide peer mentoring to depressed new and expectant mothers. Peer mentors are trained by professionals who are experts in using skills to recover from depression. These skills are informed by an evidence-based framework called Behavioral Activation (BA). Peer mentors do not provide psychotherapy and are not licensed mental health providers.

详细描述

Women have double the odds of getting depressed as men and commonly experience depression during the childbearing and early parenting years. Many new and expectant mothers who experience depression never receive help.

Alma is a new program, collaboratively developed by a team of researchers, clinicians, and mothers who have personal experience with depression, to support women experiencing depression during pregnancy and the postpartum period. We call this program Alma because the meaning of the word, in English and Spanish, captures what we hope moms will feel when they connect with this program. In English, the meaning comes from the Latin word for "nourishing" and "kind," and in Spanish, the meaning is "soul." Through the unique synergy of science and community, the Alma program provides the tools and support needed to nourish moms in supporting their own well-being.

In the Alma program, mothers who themselves have experienced and recovered from depression during the perinatal period, are trained to provide peer mentoring to depressed new and expectant mothers. Peer mentors are trained to provide 6-10 mentoring meetings with each of the new and expectant mothers with whom they are paired. The peer mentors are trained by professionals who are experts in using skills to recover from depression. These skills are informed by an evidence-based framework called Behavioral Activation (BA). Peer Mentors are trained to support and encourage self-monitoring, scheduling activities, solving problems, and bridging to informal and formal professional support. Peer mentors draw on their training and own lived experience to provide hope and reduce the social isolation and stigma associated with perinatal depression. Among the evidence-based approaches to help people recover from depression, Alma uses BA as a lens because many studies have demonstrated that these skills are effective in recovering from depression. It has been provided in a self-guided format and by lay counselors and licensed mental health providers. Peer mentors do not provide psychotherapy and are not licensed mental health providers.

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

  • Currently enrolled member of Kaiser Permanente of Colorado (KPCO)
  • Current PHQ-9 score greater than or equal to 10
  • Current Columbia-Suicide Severity Rating Scale (C-SSRS) score less than 3
  • Currently pregnant

排除标准

  • Lifetime diagnosis of bipolar disorder or psychotic symptoms
  • Dementia or cognitive impairment disorder recorded in the medical record
  • Current substance abuse behavior
  • At immediate risk of self-harm
  • Unable to speak and read English

结局指标

主要结局

Change in Patient Health Questionnaire (PHQ-9) score

时间窗: Every 2 weeks for the first 12 weeks of the study, then monthly until 3-months postpartum

Self-report measure of depression symptoms.

次要结局

  • Client Satisfaction Questionnaire (CSQ-8)(12-weeks post-randomization)
  • Change in Generalized Anxiety Disorder Questionnaire (GAD-7) score(Every 2 weeks for the first 12 weeks of the study, then monthly until 3-months postpartum)
  • Change in WHO Disability Assessment Schedule (WHODAS 2.0) score(Baseline, 12-weeks post-randomization, 3-months postpartum)
  • Parenting Stress Index-Short Form (PSI-4/SF)(3-months postpartum)
  • Working Alliance Inventory - Short Form (Intervention group only)(12-weeks post-randomization)
  • Change in Effort-Expenditure for Rewards Task (EEfRT) performance(Baseline, 12-weeks post-randomization, 3-months postpartum)
  • Change in Go/No-Go Task (GNAT) performance(Baseline, 12-weeks post-randomization, 3-months postpartum)
  • Change in Perceived Stress Scale (PSS-10) score(Baseline, 12-weeks post-randomization, 3-months postpartum)
  • Change in Behavioral Activation for Depression Scale (BADS) score(Baseline, 12-weeks post-randomization, 3-months postpartum)
  • Change in Reward-Probability Index (RPI) score(Baseline, 12-weeks post-randomization, 3-months postpartum)
  • Mother Inventory of Reward Experiences (MIRE)(3-months postpartum)
  • Change in Social Support Questionnaire - Short Form (SSQ-SF) score(Baseline, 12-weeks post-randomization, 3-months postpartum)
  • Exit Interview(3-months postpartum)
  • Change in Environmental Reward Observation Scale (EROS) score(Baseline, 12-weeks post-randomization, 3-months postpartum)
  • Change in Attitudes Toward Motherhood (AToM) score(Baseline, 12-weeks post-randomization, 3-months postpartum)
  • Change in Self- Compassion Scale (SCS) score(Baseline, 12-weeks post-randomization, 3-months postpartum)
  • Change in Experience Sampling Survey response(Baseline, 12-weeks post-randomization, 3-months postpartum)

研究者

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

Sona Dimidjian

Professor

University of Colorado, Boulder

研究点 (4)

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