NCT05548946

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

3.2 years

First QC Date

September 9, 2022

Last Update Submit

December 4, 2024

Conditions

Keywords

Personality PsychologyAgingPsychological Assessment

Outcome Measures

Primary Outcomes (2)

  • PID-5-BF+M questionnaire

    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)

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

  • LPFS-BF 2.0 questionnaire

    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)

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

Secondary Outcomes (5)

  • 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

  • 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

  • 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

Study Arms (2)

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.

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

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.

Other: PID-5-BF+M and LPFS-BF 2.0 (self-report questionnaires)Other: Secondary Questionnaires (self-report and informant questionnaires)Diagnostic Test: Clinical Ratings of the dimensional modelOther: PID-5-BF+M and LPFS-BF 2.0 (Informant questionnaires)

Interventions

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).

Clinical PopulationGeneral population

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) CERQ (Garnefski et al., 2007) UCL (Scheurs et al., 1994; 1988) BIS/BAS Scales (Carver \& White, 1994) EC Scale of the ATQ (Rothbart et al., 2000) BSI (Derogatis, 1975; Dutch version: Beurs, 2008) SIPP-SF (derived from the SIPP-118; Verheul et al., 2008) SMI (Young et al., 2008) WHO-5 (Dutch version: WHO, 1998) SQ3-SF (Young \& Brown, 2005) SCID-5-P (First et al., 2017; Dutch translation: Arntz et al., 2017)

Clinical Population

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 and Master Thesis students, trained by the doctorandus (in order not to overburden the clinicians). The clinical interviews that will be used for the ratings are: * The Semigestructureerd Interview voor Persoonlijkheidsfunctioneren DSM-5 (STIP) (Hutsebaut et al., 2014). * The Structured Clinical Interview for the DSM-5 (SCID-5-AMPD) (First et al., 2018), only if a Dutch translation is available by the time of this intervention.

Clinical Population

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 person.

Clinical Population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Alexianen Zorggroep Tienen

Tienen, Vlaams-Brabant, 3300, Belgium

RECRUITING

Mondriaan

Heerlen, Limburg, 6411 - 6422, Netherlands

NOT YET RECRUITING

Related Publications (30)

  • APA. Diagnostic and Statistical Manual of Mental Disorders, 5th ed. Washington DC: APA. 2013.

    BACKGROUND
  • World Health Organization. ICD-11: International classification of diseases (11th revision). 2019; Retrieved from https://icd.who.int/.

    BACKGROUND
  • 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: 30230242BACKGROUND
  • 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 2020 May 5.

    PMID: 32369820BACKGROUND
  • 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, Waszczuk MA, Widiger TA, Wright AGC, Zimmerman M. The Hierarchical Taxonomy of Psychopathology (HiTOP): A dimensional alternative to traditional nosologies. J Abnorm Psychol. 2017 May;126(4):454-477. doi: 10.1037/abn0000258. Epub 2017 Mar 23.

    PMID: 28333488BACKGROUND
  • 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 Feb 12.

    PMID: 33577350BACKGROUND
  • 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: 33371717BACKGROUND
  • 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.

    BACKGROUND
  • Pauwels E, Dierckx E, Smits D, Janssen R, Claes L. Validation of the Young Schema Questionnaire-Short Form in a Flemish Community Sample. Psychol Belg. 2018 Apr 23;58(1):34-50. doi: 10.5334/pb.406.

    PMID: 30479806BACKGROUND
  • van Alphen SP, Engelen GJ, Kuin Y, Hoijtink HJ, Derksen JJ. A preliminary study of the diagnostic accuracy of the Gerontological Personality disorders Scale (GPS). Int J Geriatr Psychiatry. 2006 Sep;21(9):862-8. doi: 10.1002/gps.1572.

    PMID: 16955455BACKGROUND
  • Burns A, Beevor A, Lelliott P, Wing J, Blakey A, Orrell M, Mulinga J, Hadden S. Health of the Nation Outcome Scales for elderly people (HoNOS 65+). Br J Psychiatry. 1999 May;174:424-7. doi: 10.1192/bjp.174.5.424.

    PMID: 10616609BACKGROUND
  • Barendse HPJ, Thissen AJC. Hetero-Anamnestische Persoonlijkheidsvragenlijst (de HAP): handleiding (HAP en HAP-t 2.0 Versie 2.0). Den Bosch, Netherlands. 2006.

    BACKGROUND
  • Derogatis LR. SCL-90: Administration, Scoring and Procedures Manual-I for the Revised Version and other Instruments of the Psychopathology Rating Scale Series. Baltimore, MD: Johns Hopkins University School of Medicine, Clinical Psychometrics Research Unit. 1983.

    BACKGROUND
  • Arrindell WA, Ettema JHM. Symptom checklist: handleiding bij multidimensionale psychopathologie-indicator. Amsterdam, Nederland: Pearson Assessment and Information B.V.. 1975, 1986, 2005.

    BACKGROUND
  • Schotte CK, de Doncker D, Vankerckhoven C, Vertommen H, Cosyns P. Self-report assessment of the DSM-IV personality disorders. Measurement of trait and distress characteristics: the ADP-IV. Psychol Med. 1998 Sep;28(5):1179-88. doi: 10.1017/s0033291798007041.

    PMID: 9794025BACKGROUND
  • Garnefski N, Kraaij V. The Cognitive Emotion Regulation Questionnaire: Psychometric features and prospective relationships with depression and anxiety in adults. European Journal of Psychological Assessment. 2007; 23(3): 141-149. https://doi.org/10.1027/1015-5759.23.3.141.

    BACKGROUND
  • Schreurs, Tellegen, Willige. Coping-lijst. Gedrag. 1984; 12: 101-117.

    BACKGROUND
  • Schreurs, Villige, Tellegen, Brosschot. De Utrechtse coping Lijst: uct-handleiding. Lisse: Swets & Zeitlinger. 1988.

    BACKGROUND
  • Carver, White. Behavioral inhibition, behavioral activation, and affective responses to impending reward and punishment: The BIS/BAS scales. Journal of Personality and Social Psychology. 1994; 67: 319-333.

    BACKGROUND
  • Rothbart MK, Ahadi SA, Evans DE. Temperament and personality: origins and outcomes. J Pers Soc Psychol. 2000 Jan;78(1):122-35. doi: 10.1037//0022-3514.78.1.122.

    PMID: 10653510BACKGROUND
  • Derogatis LR. Brief Symptom Inventory. Clinical Psychometric Research. Baltimore. 1975.

    BACKGROUND
  • De Beurs E. Brief symptom inventory handleiding. Leiden: The Netherlands. PITS B.V.. 2008.

    BACKGROUND
  • Verheul R, Andrea H, Berghout CC, Dolan C, Busschbach JJ, van der Kroft PJ, Bateman AW, Fonagy P. Severity Indices of Personality Problems (SIPP-118): development, factor structure, reliability, and validity. Psychol Assess. 2008 Mar;20(1):23-34. doi: 10.1037/1040-3590.20.1.23.

    PMID: 18315396BACKGROUND
  • Young, Arntz, Atkinson, Lobbestael, Weishaar, van Vreeswijk, Klokman. Nederlandse versie The Schema Mode Inventory (SMI). 2008.

    BACKGROUND
  • World Health Organisation. Wellbeing Measures in Primary Health Care/The Depcare Project. WHO Regional Office for Europe: Copenhagen. 1998.

    BACKGROUND
  • Young JE, Brown G. Young Schema Questionnaire - Short Form3 (YSQ-S3). New York, NY: Cognitive Therapy Center. 2005.

    BACKGROUND
  • Hutsebaut J, Berghuis H, De Saeger H, Kaasenbrood A, Ingenhoven T. Semistructured interview for personality functioning DSM-5 (STiP 5.1). The Podium DSM-5 research Group of the Netherlands Centre of Expertise on Personality Disorders. Utrecht: Trimbos Institute. 2014.

    BACKGROUND
  • First, Skodol, Bender, Oldham. Structured Clinical Interview for the DSM-5 Alternative Model for Personality Disorders (SCID-AMPD). American Psychiatric Association. 2018.

    BACKGROUND
  • Marjanovic Z, Struthers CW, Cribbie R, Greenglass ER. The Conscientious Re-sponders Scale. SAGE Open. 2014; 4(3). https://doi.org/10.1177/2158244014545964

    BACKGROUND
  • First, Williams, Benjamin, Smith, Spitzer, Arntz. SCID-5-P : gestructureerd klinisch interview voor DSM-5 persoonlijkheidsstoornissen. American Psychiatric Association. Amsterdam: Boom. 2018.

    BACKGROUND

MeSH Terms

Conditions

Mental Disorders

Interventions

Self Report

Intervention Hierarchy (Ancestors)

Surveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Morag Facon

    Vrije Universiteit Brussel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 22, 2022

Study Start

September 1, 2022

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

December 9, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations