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临床试验/NCT06152549
NCT06152549已完成不适用

Assessing the Emotional and Physiological Response of Adults to Completing a Self-report Scale on Exposure to Childhood Maltreatment - Online Component

Mclean Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年10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
500
试验地点
1
主要终点
Profile of Mood States (POMS)

研究概览

简要总结

Childhood adversity in the form of maltreatment and household dysfunction is the most important risk factor for psychopathology as well as a major risk factor for a host of medical disorders. It has been estimated that adverse childhood experiences account for 45%, 50%, 64% and 67% of the population attributable risk for childhood onset psychiatric disorders, alcoholism, depression, substance abuse and suicide attempts. There is also increasing evidence that maltreated and non-maltreated individuals with the same primary psychiatric diagnosis are clinically and neurobiologically distinct and respond differently to treatment. The investigators and others have proposed that assessment of exposure to maltreatment is imperative for prevention, targeted treatment and research. A potential barrier to the widespread collection of data regarding early life stress and childhood maltreatment is the concern that asking such probing questions, particularly on an online questionnaire, may provoke untoward reactions and create clinical problems.

Therefore, the investigators have designed this observational study to test our hypothesis that answering questions about type and timing of childhood maltreatment are no more stressful than answering standardized mathematical and verbal questions, of the type asked on the Scholastic Aptitude Test (SAT).

The study will include representative national samples (by age, sex, and ethnicity) from the United States (total N=500, Ages 18-65) and will be conducted online via Prolific™, which maintains a pool of research participants.

Participants will be assigned randomly to one of two test sequences.

  • In sequence 1, the Maltreatment and Abuse Chronology of Exposure (MACE) scale will be presented toward the beginning of the session and the Math/Verbal Test toward the end.
  • In sequence 2, the order will be reversed.

The impact of completing the MACE and standardized IQ questions will be assessed before and after each module, using the abbreviated form of the Profile of Mood States (POMS).

详细描述

Childhood adversity in the form of maltreatment and household dysfunction is the most important risk factor for psychopathology as well as a major risk factor for a host of medical disorders. Briefly, it has been estimated that adverse childhood experiences account for 45%, 50%, 54%, 64% and 67% of the population attributable risk for childhood onset psychiatric disorders, alcoholism, depression, substance abuse and suicide attempts, respectively. Maltreatment is also associated with increased risk for heart disease, cancer, chronic lung disease, liver disease, and shortened life span. There is increasing evidence that maltreated and non-maltreated individuals with the same primary psychiatric diagnosis are clinically and neurobiologically distinct and respond differentially to treatment. Hence, the investigators and others have proposed that assessment of exposure to maltreatment is imperative for prevention, targeted treatment, and research.

However, a potential barrier to widespread collection of data regarding early life stress and childhood maltreatment is the concern that asking such probing questions, particularly on an online questionnaire, may provoke untoward reactions and create clinical problems. To date, the investigators have collected maltreatment data on over 3000 participants without a single call from participants about feeling distressed. While some IRBs permit collection of this information online, the investigators are aware of colleagues at other universities who have had their request denied.

Our thought is that whatever human subjects' limitations should be imposed on collecting childhood maltreatment data via self-report should not simply be a matter of opinion but should be based on evidence.

Hence, the investigators are proposing to specifically study the acute emotional response of volunteer participants, especially those with a history of self-reported childhood maltreatment, to completing a detailed self-report instrument on type and timing of exposure to childhood maltreatment. For contrast, the investigators will also compare their response to completing a series of mathematical and verbal questions, of the type asked on the Scholastic Aptitude Test (SAT), as an example of the type of questions that can be asked without human subject approval.

Our primary hypothesis is that endeavoring to answer these questions will be more stressful and emotionally provocative than questions regarding history of childhood maltreatment, even in participants who report moderate-to-high levels of childhood maltreatment.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers ages 18-65, living full-time in the U.S at the time of participation in the study.

排除标准

  • Below 18 or above
  • Living outside the U.S at the time of participation in the study.

结局指标

主要结局

Profile of Mood States (POMS)

时间窗: Through study completion, an average of 90 mins

The abbreviated form of the POMS(40-items) provides ratings of anger-hostility, confusion-bewilderment, depression-dejection, fatigue-inertia, tension-anxiety, vigor-activity, friendliness and a total mood disturbance score. It takes only 3-5 minutes to complete. Items are scored as Not at all(0), A little(1), Moderately(2), Quite a lot(3), Extremely(4). Scores for the seven subscales in the abbreviated POMS are calculated by summing the numerical ratings for items that contribute to each subscale, with two items "Ashamed" and "Embarrassed" reverse scored.

Total Mood Disturbance (TMD)

时间窗: Through study completion, an average of 90 mins

Total Mood Disturbance (TMD) is calculated by summing the totals for the POMS negative subscales and then subtracting the totals for the POMS positive subscales. The formula is as follows: TMD = \[Tension+Depression+Anger+Fatigue+Confusion\] - \[Vigor+Esteem-related Affect\]

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

Martin H Teicher

Associate Professor of Psychiatry

Mclean Hospital

研究点 (1)

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