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Recruiting NCT05548946

A Dimensional Model for Personality Disorders in Later Life

No phase Interventional Psychiatric Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PID-5-BF+M and LPFS-BF 2.0 (self-report questionnaires), Secondary Questionnaires (self-report and informant questionnaires), Clinical Ratings of the dimensional model, PID-5-BF+M and LPFS-BF 2.0 (Informant questionnaires).
Who it may be relevant to
Registry conditions: Psychiatric Disorders. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other PID-5-BF+M and LPFS-BF 2.0 (self-report questionnaires)
    All participants will be asked to fill in the PID-5-BF+M and the LPFS-BF 2.0 to examine personality disorders as defined by the AMPD and ICD-11. PID-5-BF+M consists of 36 self-report items. It has 18 facet scales and 6 domain scales (Anankastia, Negative Affectivity, Antagonism, Disinhibition, Psychoticism and Detachment). The LPFS-BF 2.0 has 12 items, measuring 4 domains of personality functioning (identity, intimacy, self-direction and empathy).
  • Other Secondary Questionnaires (self-report and informant questionnaires)
    The patients fill in a standard test battery during the first weeks of their admission in the institutions, including questionnaires and interviews. The research team will analyze the results retrospectively. This includes: YSQ- SF16 (Young \& Brown, 1994; Pauwels et al., 2018) GPS (van Alphen et al., 2006) HoNOS 65+ (Burns et al., 1999) HAP 2.0 (Barendse \& Thissen, 2006) SCL-90-R (Derogatis, 1983; Dutch version: Arrindell, \& Ettema, 1975, 1986, 2005) ADP-IV (Schotte \& De Doncker, 1998) CER
  • Diagnostic test Clinical Ratings of the dimensional model
    Clinical ratings of criteria A and B will also be collected. Only a small part of the patients will be selected for this, in order to make the research more feasible. The rater (a clinician or researcher) assesses the patient (in terms of level of personality functioning and personality traits) by means of (structured) clinical interviews. Given clinical ratings of the dimensional criteria are not part of the standard care in either institution, the ratings can be conducted by the doctorandus an
  • Other PID-5-BF+M and LPFS-BF 2.0 (Informant questionnaires)
    In the clinical population, participants will be asked to include an informant (family member, partner, friend, acquaintance), to fill in an informant version of the PID-5-BF+M and LPFS-BF 2.0 questionnaires. It is also possible for the patient to participate in the study without giving permission to include an informant. The informant will be asked to fill in the informant versions of the questionnaires, which contain the exact same items as the self-report versions, adjusted to the third perso

Primary outcome measures

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

Eligibility criteria

Clinical population (inpatients and outpatients)

Inclusion criteria

  • ONLY older adults: from the age of 65
  • Dutch speaking

Exclusion Criteria (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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Belgium · 1 center
  • Alexianen Zorggroep Tienen — Tienen
Netherlands · 1 center
  • Mondriaan — Heerlen

Publications

  • APA. Diagnostic and Statistical Manual of Mental Disorders, 5th ed. Washington DC: APA. 2013.
  • World Health Organization. ICD-11: International classification of diseases (11th revision). 2019; Retrieved from https://icd.who.int/.
  • Weekers LC, Hutsebaut J, Kamphuis JH. The Level of Personality Functioning Scale-Brief Form 2.0: Update of a brief instrument for assessing level of personality functioning. Personal Ment Health. 2019 Feb;13(1):3-14. doi: 10.1002/pmh.1434. Epub 2018 Sep 19. PMID 30230242
  • Bach B, Kerber A, Aluja A, Bastiaens T, Keeley JW, Claes L, Fossati A, Gutierrez F, Oliveira SES, Pires R, Riegel KD, Rolland JP, Roskam I, Sellbom M, Somma A, Spanemberg L, Strus W, Thimm JC, Wright AGC, Zimmermann J. International Assessment of DSM-5 and ICD-11 Personality Disorder Traits: Toward a Common Nosology in DSM-5.1. Psychopathology. 2020;53(3-4):179-188. doi: 10.1159/000507589. Epub 20 PMID 32369820
  • Kotov R, Krueger RF, Watson D, Achenbach TM, Althoff RR, Bagby RM, Brown TA, Carpenter WT, Caspi A, Clark LA, Eaton NR, Forbes MK, Forbush KT, Goldberg D, Hasin D, Hyman SE, Ivanova MY, Lynam DR, Markon K, Miller JD, Moffitt TE, Morey LC, Mullins-Sweatt SN, Ormel J, Patrick CJ, Regier DA, Rescorla L, Ruggero CJ, Samuel DB, Sellbom M, Simms LJ, Skodol AE, Slade T, South SC, Tackett JL, Waldman ID, PMID 28333488
  • Kotov R, Krueger RF, Watson D, Cicero DC, Conway CC, DeYoung CG, Eaton NR, Forbes MK, Hallquist MN, Latzman RD, Mullins-Sweatt SN, Ruggero CJ, Simms LJ, Waldman ID, Waszczuk MA, Wright AGC. The Hierarchical Taxonomy of Psychopathology (HiTOP): A Quantitative Nosology Based on Consensus of Evidence. Annu Rev Clin Psychol. 2021 May 7;17:83-108. doi: 10.1146/annurev-clinpsy-081219-093304. Epub 2021 F PMID 33577350
  • Kerber A, Schultze M, Muller S, Ruhling RM, Wright AGC, Spitzer C, Krueger RF, Knaevelsrud C, Zimmermann J. Development of a Short and ICD-11 Compatible Measure for DSM-5 Maladaptive Personality Traits Using Ant Colony Optimization Algorithms. Assessment. 2022 Apr;29(3):467-487. doi: 10.1177/1073191120971848. Epub 2020 Dec 28. PMID 33371717
  • Young JE, Brown G. Young Schema-Questionnaire (2nd ed.). In J. E. Young (Ed.), Cognitive therapy for personality disorders: A schema-focused approach. Sarasota, FL: Professional Resource Press. 1994; Rev. ed., 63- 76.

Identifiers

NCT: NCT05548946 · BUN:1432021000713

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗