Psychiatric DisordersNCT05548946
A Dimensional Model for Personality Disorders in Later Life
A study testing PID-5-BF+M and LPFS-BF 2.0 (self-report questionnaires), Secondary Questionnaires (self-report and informant questionnaires) and Clinical Ratings of the dimensional model in people with Psychiatric Disorders, run by Universitair Ziekenhuis Brussel at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychiatric Disorders
- What is being tested?
- PID-5-BF+M and LPFS-BF 2.0 (self-report questionnaires), Secondary Questionnaires (self-report and informant questionnaires) and Clinical Ratings of the dimensional model
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2022to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Gina Rossi contact
2 sites in 2 countries
Belgium1 site, 1 recruiting
- Recruiting
Alexianen Zorggroep Tienen
Tienen, Vlaams-Brabant, 3300
Eva Dierckx
Netherlands1 site, 1 recruiting
- Not yet recruiting
Mondriaan
Heerlen, Limburg, 6411 - 6422
Bas van Alphen
About this study
Official title: Empirical Evaluation and Clinical Relevance of a Dimensional Model for Personality Disorders in Later Life
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.
Read the 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.
- 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).
- 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.
- Conditions
- Psychiatric Disorders
- Being tested
- 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)
- Keywords
- Personality Psychology, Aging, Psychological Assessment
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PID-5-BF+M and LPFS-BF 2.0 (self-report questionnaires)Other
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).
Secondary Questionnaires (self-report and informant questionnaires)Other
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 Ratings of the dimensional modelDiagnostic test
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.
PID-5-BF+M and LPFS-BF 2.0 (Informant questionnaires)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 model; Other: PID-5-BF+M and LPFS-BF 2.0 (Informant questionnaires) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Scale scores and total scores of the questionnaires.
The informant versions of the questionnaires consist of the same scales as the self-report versions.
Measured: 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
Scale scores and total scores of the questionnaires.
The informant versions of the questionnaires consist of the same scales as the self-report versions.
Measured: 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
The total scores and scale scores of the clinical rating.
After conducting the clinical ratings with STIP and/or SCID-5-AMPD, the rater gives a clinical rating on criterion B as defined by DSM-5:
A description of the criterion B domains and each of the facets is given, as well as a possibility for rating, ranging from 0 (not at all descriptive) to 3 (extremely descriptive). These scores then make up the clinical scale scores and total score of The PID-5-BF+M.
Measured: 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
The total scores and scale scores of the clinical rating.
After conducting the clinical ratings with STIP and/or SCID-5-AMPD, the rater gives a clinical rating on criterion A defined by DSM-5:
DSM-5 offers descriptions of the four dimensions of criteria A (identity, self-direction, intimacy and empathy) and asks the rater to give an assessment on a Likert-scale ranging from 0 (healthy) to 4 (severely impaired). These scores then make up the clinical scale scores and total score of the LPFS-BF 2.0.
Measured: Throughout the patient's hospitalization and the study completion, on average 1 year after the start of data collection
Secondary measures
The total scores and scale scores of the questionnaires.
The scores of the secondary questionnaires will be used to examine validity research questions. A list of these instruments can be found in the section interventions.
Measured: Throughout the patient's first weeks of being in in- or outpatient, on average 1 month after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start1 Sep 2022
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Psychiatric DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium, Alexianen Zorggroep Tienen, Mondriaan, GGZ Breburg
- Responsible party
- Sponsor
- Investigators
- Morag Facon, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548946
- Sponsor's protocol ID
- BUN:1432021000713
- Status last verified
- Dec 2024
- First submitted
- 9 Sep 2022
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30230242Bach 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.
PubMed 32369820Kotov 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.
PubMed 28333488Kotov 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.
PubMed 33577350Kerber 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.
PubMed 33371717Young 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.
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.
PubMed 30479806van 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.
PubMed 16955455Burns 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.
PubMed 10616609Barendse HPJ, Thissen AJC. Hetero-Anamnestische Persoonlijkheidsvragenlijst (de HAP): handleiding (HAP en HAP-t 2.0 Versie 2.0). Den Bosch, Netherlands. 2006.
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.
Arrindell WA, Ettema JHM. Symptom checklist: handleiding bij multidimensionale psychopathologie-indicator. Amsterdam, Nederland: Pearson Assessment and Information B.V.. 1975, 1986, 2005.
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.
PubMed 9794025
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empirical Evaluation and Clinical Relevance of a Dimensional Model for Personality Disorders in Later Life
- ClinicalTrials.gov ID
- NCT05548946
- Acronym / sponsor ID
- BUN:1432021000713
- Conditions
- Psychiatric Disorders
- Keywords
- Personality Psychology, Aging, Psychological Assessment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium, Alexianen Zorggroep Tienen, Mondriaan, GGZ Breburg
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 22 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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).
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General population | Other | Other: PID-5-BF+M and LPFS-BF 2.0 (self-report questionnaires)In this group, younger adults (18-64) and older (from 65 and older) from the general population are included. The participants fill in questionnaires. |
| Clinical Population | Other | 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 model, Other: PID-5-BF+M and LPFS-BF 2.0 (Informant questionnaires)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Clinical Population, General population |
| 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) 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) | Other | Clinical Population |
| Clinical Ratings of the dimensional modelClinical 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. | Diagnostic test | Clinical Population |
| 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 person. | Other | Clinical Population |
Primary outcome
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
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
Time frame: 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)
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- BackgroundAPA. Diagnostic and Statistical Manual of Mental Disorders, 5th ed. Washington DC: APA. 2013.
- BackgroundWorld Health Organization. ICD-11: International classification of diseases (11th revision). 2019; Retrieved from https://icd.who.int/.
- Background: PubMed 30230242Weekers 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.
- Background: PubMed 32369820Bach 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.
- Background: PubMed 28333488Kotov 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.
- Background: PubMed 33577350Kotov 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.
- Background: PubMed 33371717Kerber 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.
- BackgroundYoung 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: PubMed 30479806Pauwels 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.
- Background: PubMed 16955455van 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.
- Background: PubMed 10616609Burns 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.
- BackgroundBarendse HPJ, Thissen AJC. Hetero-Anamnestische Persoonlijkheidsvragenlijst (de HAP): handleiding (HAP en HAP-t 2.0 Versie 2.0). Den Bosch, Netherlands. 2006.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gina Rossi contact
Morag Facon principal investigator
Vrije Universiteit Brussel
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PID-5-BF+M and LPFS-BF 2.0 (self-report questionnaires), Secondary Questionnaires (self-report and informant questionnaires) and Clinical Ratings of the dimensional model in people with Psychiatric Disorders, run by Universitair Ziekenhuis Brussel at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Morag Facon (+32493596294, morag.flora.facon@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05548946, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.