跳至主要内容
临床试验/NCT05548946
NCT05548946招募中不适用

Empirical Evaluation and Clinical Relevance of a Dimensional Model for Personality Disorders in Later Life

Universitair Ziekenhuis Brussel2 个研究点 分布在 2 个国家目标入组 750 人开始时间: 2022年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
750
试验地点
2
主要终点
PID-5-BF+M questionnaire

研究概览

简要总结

Research on personality disorders (PDs) in older adults is currently limited. This is surprising, given that PDs are also common in this age group. Moreover, PDs show high co-morbidity with other disorders (both mental and physical) and often have a negative effect on treatment. With this in mind, the conceptualization, diagnosis and treatment of PDs in older adults represents an important task for mental health care. To this end, problems with the current classification of PDs need to be tackled, as they currently complicate this task. The current DSM-5 (Diagnostic and Statistical Manual, Edition 5) (APA, 2013) categorical PD criteria are mainly based on the living conditions of younger adults and are therefore often not suited for PD diagnosis in older adults. Currently, however, a paradigm shift is taking place from a categorical to a dimensional approach of PDs. The "Alternative Model for Personality Disorders" (AMPD) (APA, 2013) and the approach by ICD-11 (International Classification of Diseases 11th Revision) (WHO, 2019) are examples of new, dimensional models for PDs. These models conceptualize PDs using two dimensional criteria: (1) criterion A, which captures the overall level of personality (dis)functioning and (2) criterion B which describes the PD style by pathological/maladaptive personality traits. This paradigm shift offers the possibility to give the aging context the attention it deserves, by examining the suitability of this new dimensional conceptualization of PD among older adults.

The goal of this research is to examine whether the combined AMPD and ICD-11 dimensional approach is appropriate for use in older adults. This will be done by administering instruments capturing criterion A and B in the general population in younger (18-64) and older (65 and older) adults to evaluate their age-neutrality, as well as in a clinical sample of older (65 and older) adults, to empirically evaluate its clinical relevance in later life.

详细描述

In the current study, the investigators want to give the ageing context the attention it deserves by examining whether the AMPD and ICD-11 approach is appropriate for use in older adults. This will happen by means of two central objectives, each divided in different research questions.

  1. The first central objective is the validation of the AMPD and ICD-11 conceptualization of PDs and its corresponding instruments, in older adults. Even though early research shows promising results for the use of dimensional classification in older adults, both of the questionnaires were originally developed and validated in younger adult samples. Therefore, this research is interested in the examination of the model and its corresponding instruments in older adults. The two instruments that will be used in the study are the Level of Personality Functioning Scale - Brief Version 2.0 (LPFS-BF 2.0) (Weekers et al., 2018) and the Personality Inventory for DSM-5 - Brief Version Modified (PID-5-BF+M) (Bach et al., 2020), which measure criterion A and criterion B, respectively. In this study, the abbreviated version of both questionnaires were chosen, in order not to unnecessarily burden the older participants.

Firstly, the construct validity of the questionnaires in the general population will be examined. Then, the age-neutrality of the questionnaires (i.e. to what extent younger and older adults having the same degree of personality pathology have the same probability of endorsing related items on the questionnaires) will be investigated. In case non-age-neutral items appear, the investigators will adjust these to obtain age-neutrality. This first research question will occur in the general population. After age neutrality has been demonstrated (possibly after adjustments of the questionnaires), the instrument will be applied in the clinical institutions to evaluate the rest of the research questions. In the clinical population, the construct validity of the questionnaires will be investigated. Construct validity will be evaluated by examining the factor structure of the questionnaires and correlations with other measures of psychopathology (e.g. symptoms of depression and anxiety measured by Brief Symptom Inventory or SCL-90-R). Furthermore, the clinical utility of the questionnaires will be investigated, by examining their ability to distinguish individuals with PDs from those without personality pathology. In addition to research on the psychometric qualities of the questionnaires, the investigators will also validate the AMPD and ICD-11 conceptualization of PDs in two criteria, in older patients by examining the incremental validity of criterion A, above and beyond criterion B. This means the investigators will determine the extent to which criterion A and criterion B can be distinguished from each other and whether they can be differentiated from each other (or in other words do not contain (too much) overlapping information). 2. The second central objective focuses on enhancing general knowledge about the structure and characteristics of PDs in older adults, by positioning PDs in a comprehensive framework of psychopathology, namely the HiTOP model (Hierarchical Taxonomy of Psychopathology) (Kotov et al., 2017). The HiTOP model is an empirical dimensional model that brings together PDs and other clinical disorders in a hierarchical structure, based on their shared transdiagnostic factors. To date, this model has not yet been investigated in older adults (Kotov et al., 2021). With this study, the proposed HiTOP structure will be tested in 65+, in order to gain more insight into the underlying transdiagnostic factors that characterize PDs in older adults, with the ultimate goal of better care and treatment tailored to the older patient.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • •Clinical population (inpatients and outpatients)
  • •Inclusion Criteria:
  • •ONLY older adults: from the age of 65
  • •Dutch speaking

排除标准

  • •(as evaluated by the psychiatrists and psychologists of the participating institutions):
  • •Severe cognitive impairment (Patients who are admitted because of cognitive impairment will be excluded from the participant pool, other than this the psychiatrists and psychologists of the participating institutions will make an evaluation of the patients' cognitive capacities)
  • •Acute state of mental impairment which would interfere with the reliability of the patients' responses (for example severe psychosis), as evaluated by the psychiatrists and psychologist of the participating institutions.

研究组 & 干预措施

General population

Other

In this group, younger adults (18-64) and older (from 65 and older) from the general population are included. The participants fill in questionnaires.

干预措施: PID-5-BF+M and LPFS-BF 2.0 (self-report questionnaires) (Other)

Clinical Population

Other

In this group, in- and outpatients from the clinical population are included. This are older adults, from the age of 65 with varying psychological pathologies (such as anxiety disorders, mood disorders, substance use disorders, developmental disorders, personality pathology, grief, trauma-related disorders, psychosocial problems, psychosis and schizophrenia-related disorders and somatic disorders). The patients fill in questionnaires and a randomly selected smaller group of patients will conduct a clinical interview.

干预措施: Clinical Ratings of the dimensional model (Diagnostic Test)

Clinical Population

Other

In this group, in- and outpatients from the clinical population are included. This are older adults, from the age of 65 with varying psychological pathologies (such as anxiety disorders, mood disorders, substance use disorders, developmental disorders, personality pathology, grief, trauma-related disorders, psychosocial problems, psychosis and schizophrenia-related disorders and somatic disorders). The patients fill in questionnaires and a randomly selected smaller group of patients will conduct a clinical interview.

干预措施: PID-5-BF+M and LPFS-BF 2.0 (Informant questionnaires) (Other)

Clinical Population

Other

In this group, in- and outpatients from the clinical population are included. This are older adults, from the age of 65 with varying psychological pathologies (such as anxiety disorders, mood disorders, substance use disorders, developmental disorders, personality pathology, grief, trauma-related disorders, psychosocial problems, psychosis and schizophrenia-related disorders and somatic disorders). The patients fill in questionnaires and a randomly selected smaller group of patients will conduct a clinical interview.

干预措施: PID-5-BF+M and LPFS-BF 2.0 (self-report questionnaires) (Other)

Clinical Population

Other

In this group, in- and outpatients from the clinical population are included. This are older adults, from the age of 65 with varying psychological pathologies (such as anxiety disorders, mood disorders, substance use disorders, developmental disorders, personality pathology, grief, trauma-related disorders, psychosocial problems, psychosis and schizophrenia-related disorders and somatic disorders). The patients fill in questionnaires and a randomly selected smaller group of patients will conduct a clinical interview.

干预措施: Secondary Questionnaires (self-report and informant questionnaires) (Other)

结局指标

主要结局

PID-5-BF+M questionnaire

时间窗: Throughout the patient's first weeks of being in in- or outpatient, on average 1 month after admission

Item scores, scale scores and total scores of the questionnaire Items: - 38 items (36 original items + 2 additional items) Scale scores: * 19 personality facets (18 original facet scores + additional facet made up from the additional items) (Emotional Lability, Anxiety, Separation Insecurity, Withdrawal, Anhedonia, Intimacy Avoidance, Manipulativeness, Deceitfulness, Grandiosity, Irresponsibility, Impulsivity, Distractibility, Perfectionism, Rigidity, Orderliness, Unusual Beliefs \& Experiences, Eccentricity, Perceptual Dysregulation and Perseveration) * 7 personality domains (6 original domains + alternative composition of the Anankastia domain)(Negative Affectivity, Detachment, Antagonism, Disinhibition, Anankastia, Psychoticism and Anankastia by Kerber et al., 2019)

LPFS-BF 2.0 questionnaire

时间窗: Throughout the patient's first weeks of being in in- or outpatient, on average 1 month after admission

Item scores, scale scores and total scores of the questionnaire Items: - 12 items Scale scores: - 4 domains of personality functioning (identity, intimacy, self-direction and empathy)

次要结局

  • The PID-5-BF+M informant version questionnaire(Throughout the patient's first weeks of being in in- or outpatient, on average 1 month after admission)
  • LPFS-BF 2.0 informant version questionnaire(Throughout the patient's first weeks of being in in- or outpatient, on average 1 month after admission)
  • LPFS-BF 2.0 clinical rating result(Throughout the patient's hospitalization and the study completion, on average 1 year after the start of data collection)
  • Secondary measures(Throughout the patient's first weeks of being in in- or outpatient, on average 1 month after admission)
  • The PID-5-BF+M clinical rating(Throughout the patient's hospitalization and the study completion, on average 1 year after the start of data collection)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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