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临床试验/NCT03836456
NCT03836456Unknown不适用

Defining Approaches That Support the Mental Health of Post-secondary Students Who Experienced More Than Three Adverse Childhood Experiences

Dalhousie University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
2
主要终点
Hope

研究概览

简要总结

The objective of this study is to understand the prevalence of adverse childhood experiences (ACE) in students and to determine whether Mindfulness based stress resilience training (MBSR) is effective for promoting mental health in students with high ACE scores (>3). A double-blind randomized control study will examine the efficacy of MBSR in promoting positive change in measures of hope, rumination, forgiveness and stress.

详细描述

The Adverse Childhood Experiences Study examined the physical health and psychosocial consequences of ACE across the lifespan. This study demonstrated adverse childhood experiences (ACE) prevalence to be high and a direct correlation between ACE scores (a tally of different types of abuse, neglect, and household dysfunction experienced under the age of 18) and prevalence of physical health and psychosocial problems in adulthood. Adults with >3 ACE are more likely to experience social underachievement (e.g. lower educational achievement and economic productivity), physical and mental health problems (e.g. depression, heart disease, suicide attempts, substance abuse) and unhealthy lifestyle behaviours (e.g. smoking, physical inactivity). Worldwide, ACE have been shown to be prevalent, independent of social and economic factors, and highly interrelated. 12.5% of subjects reported >4 ACE. Among post-secondary students, studies determined high ACE scores to be associated with higher prevalence of risk behaviours and physical health and psychosocial problems. Failure to support the physical and mental health of students can lead to increased attrition, deterioration of well-being, and intentional self-harm.

Recognition of ACE prevalence and its consequences has been paralleled by the development of interventions for mitigating the lifetime health and social consequences of ACE. A 2016 study examining interventions believed to improve the mental health of adults with significant ACE (>3) identified mindfulness-based therapies (MBT) as being effective. Mindfulness is a form of cognitive training that cultivates self-regulative ability and enhances resilience.

As no Canadian post-secondary institution has comprehensively investigated the prevalence of student ACE, the objective of this study is to understand the prevalence of ACE in students and to determine whether MBT is effective for promoting mental health in students with high ACE scores (>3).

A double-blind randomized control study will examine the efficacy of MBT, specifically Mindfulness-based Stress Resilience Training (MBSR), in promoting positive change in measures of hope, rumination, forgiveness and distress. Interventions that positively effect these measures are known to enhance quality of life. First year students enrolled at Dalhousie University will be recruited. Subjects will complete an ACE questionnaire and those with >3 ACE prior to age 18 will be invited to participate in this study. Students with prior MBT training will be excluded. Subjects will be randomized to one of two groups: MBSR or an established active control (Health Enhancement Program (HEP)). We selected MBSR because it is secular, codified, and the most scientifically studied mindfulness-based intervention to date. Power analyses determined 25 subjects per group is sufficient to detect a significant difference in outcomes across the groups. Interventionists and subjects will be blinded. Students will be led in group based MBSR or HEP for 4 weeks. Prior to and after the 4-week intervention subjects' outcomes will be determined using the: Perceived Stress Scale; Rumination and Reflection Questionnaire; Heartland Forgiveness Scale and; Adult Dispositional Hope Scale.

Development of evidence-based programs that support the identification of ACE in students and identification of interventions that mitigate negative lifetime consequences of ACE outcomes is needed. This pilot study will increase understanding of Canadian student ACE and assess the effectiveness of MBSR as a tool for supporting the mental health of students who have experienced significant ACE.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Data collected will be coded and codes will not be revealed to the investigators or outcome assessors until after data analysis is complete. The study participants will be told they are participating in an intervention to promote mental health but not told which of the 2 interventions is the active control.

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Post-secondary education students who are over the age of 18 and who had experienced more than 3 Adverse Childhood Experiences

排除标准

  • Persons who had received prior training in mindfulness based approaches.

研究组 & 干预措施

Experimental Intervention

Experimental

Mindfulness Based Stress Resilience Training: This approach will be conducted with study participants for 4 weeks. One evening per week.

干预措施: Mindfulness-based Stress Resilience Training (Behavioral)

Active Control Intervention

Active Comparator

Health Enhancement Program: This is a validated active comparator used in Mindfulness-based training studies. It will be conducted with the participants one evening per week for 4 weeks.

干预措施: Health Enhancement Program (Behavioral)

结局指标

主要结局

Hope

时间窗: Pre and post intervention (1 week)

Measured using the Adult Dispositional Hope Scale

Stress

时间窗: Pre and Post intervention (1 week)

Measure of current stress using the Perceived Stress Scale

Rumination and Reflection

时间窗: Pre and post intervention (1 week)

Measured using the Rumination and Reflection Questionnaire

Forgiveness

时间窗: Pre and post intervention (1 week)

Measures using the Heartland Forgiveness Scale

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

Rob Gilbert

Associate Professor

Dalhousie University

研究点 (2)

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