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Kognitivní model pro behaviorální intervence jako personalizovaná intervence pro pacienty s vážným duševním onemocněním

26. září 2026 aktualizováno: Saskia Bollen, Vrije Universiteit Brussel

Kognitivní model pro behaviorální intervence (CoMBI) jako personalizovaná behaviorální intervence pro pacienty s vážným duševním onemocněním

The aim of this clinical study is to investigate whether CoMBI-SMI helps to reduce behavioral problems and psychiatric complaints in Serious Mental Illness (SMI) populations complaints and to reduce the burden on informal caregivers. It will also be examined whether there is an improvement in the quality of life of the participants. Participants are asked to complete two questionnaires. Then the participants receive treatment as is normally given in a clinical department. In particular, the caregivers will be asked to observe the behavior of the participants using a questionnaire and to follow a CoMBI-training to better tailor the treatment to the core needs of the participants. Comparisons will be made within the participant group because measurements take place before and after the procedure.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

In this study, the effectiveness of a treatment protocol for a personalized approach to behavioral problems, based on the core needs of patients based on their specific personality traits will be investigated. Patients will be recruited from clinical departments of (top) specialist mental health care institutions. Both adult (18-64 years old) and older adults (≥ 65 years) patients with SMI will be included in this study. Primary outcome measures are the Neuropsychiatric Inventory-Questionnaire (NPI-Q) and Brief Symptom Inventory (BSI). Secondary outcome measures are the burden of care for the team and the patient's quality of life, measured with the NPI-Q and Mental Health Quality of life (MHQoL-7D), respectively. Furthermore, predictive factors are mapped for the primary and secondary outcome measures. The gathered NPI-Q data will then be used for a validation study, where the construct validity, internal consistency and inter-rater reliability of the NPI-Q in an SMI population will be assessed.

Individual or group psychotherapy for SMI is not always possible because several patients are unwilling or unable to accept such treatment. Mediation therapy is an alternative, in which interventions are used via a team of professionals to bring about behavioral change in the patient. Unfortunately, there are only a few guidelines and protocols available in the field of mediation therapy. Therefore, the aim of this study will be the development of CoMBI-SMI for the SMI-population. CoMBI-SMI is a combination of cognitive behavioral therapy based upon Beck's cognitive model of personality disorders and nursing interventions from the Nursing Interventions Classification. Triggers from the environment may create a behavioral problem that is maintained by its consequences. The behavioral problems are first identified by the team. Based on this analysis, a core need is selected from the CoMBI-SMI protocol and the associated nursing interventions are selected. This is described in a CoMBI-plan and evaluated cyclically.

Healthcare providers of the departments will be trained in CoMBI-SMI. The training will consist of an online theoretical part about the model followed by a Meet-The-Expert meeting (MTE), where healthcare providers can ask questions about the theoretical part and where CoMBI-SMI will be practiced on the basis of case studies. Quality criteria are linked to the online training, wherein the theoretical part is tested by means of case studies.

According to a stepped wedge design cross-overtime from condition A to CoMBI-SMI varies across participating teams. Condition A is treatment as usual (TAU) with measurements each 4 weeks and the effect is measured by the NPI-Q, BSI and the MHQoL-7D. To properly identify the core needs for the CoMBI-SMI approach, the personality questionnaires Personality Inventory for Diagnostic and Statistical Manual of Mental Disorders edition 5 (PID-5-Brief form+Modified) and the Level of Personality Functioning-scale brief 2.0 (LPFS-Brief form 2.0) will be used. Then, the CoMBI training takes place and CoMBI-SMI is performed with also measurements each 4 weeks and the effect is measured with the same outcome measures.

Typ studie

Intervenční

Zápis (Aktuální)

94

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

    • Limburg
      • Heerlen, Limburg, Holandsko, 6229ED
        • Mondriaan

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • psychogeriatric inpatients aged 18+
  • presence of SMI and behavioral problems
  • willingness and ability to participate in this study.

Exclusion Criteria:

  • behavioral problems caused by delirium
  • current substance-related disorder
  • treatment in forensic psychiatry at the time of study
  • manic phase
  • florid psychosis
  • when the behavioral problems arise directly from acquired brain injury.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: People with Serious Mental Illness

The target groups are adult (18 to 65 years) and elderly (over 65 years) patients with a Serious Mental Illness. Inclusion criteria: presence of SMI and behavioral problems, willingness and ability to participate in this research.

The first step is analysis of the behavioral problem because the core need is insufficiently compensated by the current environment or counteracted by the behavior of people within that environment. Step 2 is to choose the right core need based on this analysis. CoMBI-SMI describes the patient's self-image, the image of others, the triggering events and the problematic behavior of the patient based on personality disorders as classified by the Diagnostical and Statistical Manual of Mental Disorders. Step 3 is to choose the nursing intervention that is easily deployable so that Healthcare providers can identify the underlying core need and reduce the behavioral problems and burden on the healthcare providers. The fourth and final step is to draw up a CoMBI plan. The CoMBI-SMI is a cyclical process where it is important that the entire team is aligned with the patient's behavioral approach. Interventions are carried out by the entire team and evaluated after an agreed period of time.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Neuropsychiatric Inventory - Questionnaire (NPI-Q)
Časové okno: Before the start of TAU, before the CoMBI-SMI training and after 4 weeks of CoMBI-SMI-training

The NPI-Q was developed and validated in 2000 and translated into Dutch in 2002. The NPI-Q contains 12 domains that can be used to map neuropsychiatric symptoms. These domains are: delusions; hallucinations; agitation/aggression; depression/dysphoria; fear; euphoria / elation; apathy/indifference; disinhibited behavior; irritability/lability; aimless repetitive behavior; night restlessness/sleep disorder; appetite/eating behavior change. The questionnaire is completed by the patient's caregiver and charts whether a particular symptom is present or not, how severe this symptom is (on a three-point scale) if present, and how severe the emotional burden of this symptom is for the caregiver (on a six-point scale). The test-retest correlation of the NPI-Q for symptom severity is 0.80 and for emotional burden is 0.94. The convergent validity, compared to the NPI, is 0.91 for symptom severity and 0.92 for emotional burden.

Before the start of TAU, before the CoMBI-SMI training and after 4 weeks of CoMBI-SMI-training
Brief Symptom Inventory (BSI)
Časové okno: Before the start of TAU, before the CoMBI-SMI training and after 4 weeks of CoMBI-SMI-training

The Brief Symptom Inventory (BSI) is a multidimensional complaints list that shows the extent to which the patient suffered from psychological and/or physical symptoms during the past period. This test also gives a score for the total number of complaints, the total symptoms present and the severity of the symptoms present. The test consists of 53 items scored from "not at all = 0" to "very much = 4". There are 9 subscales: Somatic complaints; Cognitive problems; Interpersonal sensitivity; Depressed mood; Fear; Hostility; Phobic fear; Paranoid thoughts; Psychoticism. The test is sensitive to therapy influences. The BSI is a sufficiently reliable and valid test. The test is standardized for the Dutch language area with the norm groups men vs. women and general population vs. patients. The currently available norm groups were established in 2011.

Before the start of TAU, before the CoMBI-SMI training and after 4 weeks of CoMBI-SMI-training

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Mental Health Quality of Life (MHQoL-7D)
Časové okno: Before the start of TAU, before the CoMBI-SMI training and after 4 weeks of CoMBI-SMI-training

The Mental Health Quality of Life (MHQoL-7D) measures the quality of life in people with mental health problems. The MHQoL-7D is a standardized instrument consisting of two parts: a descriptive section, the MHQoL-7D, and a visual analog scale. The MHQoL-7D consists of seven questions covering seven dimensions, each with four response levels ranging from very satisfied to very dissatisfied: self-esteem, independence, mood, relationships, daily activities, physical health, and future. The total score can range from 0 to 21; the higher the score, the better the quality of life. The MHQoL visual analog scale measures the respondent's general psychological well-being on a horizontal scale ranging from zero, 'only imaginable psychological well-being' to ten, 'best imaginable psychological well-being'.

Before the start of TAU, before the CoMBI-SMI training and after 4 weeks of CoMBI-SMI-training

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Personality Inventory for Diagnostic and Statistical Manual of Mental Disorders edition 5 (PID-5-BF+Modified)
Časové okno: Once before the start of the CoMBI-SMI training.

The Personality Inventory for Diagnostic and Statistical Manual of Mental Disorders edition 5 is a 220-item self-report list of five domains (Negative Affectivity, Detachment, Antagonism, Disinhibition and Psychoticism) and the 25 associated facets of Criterion B measured from the Alternative Personality Disorder Model. The instrument can be used as a reliable screening measure for dimensional maladaptive personality traits. From the longer version PID-5-dutch version it is possible to use the shorter version, the PID-5-Brief form+Modified. The proposed study uses the shortened self-report version and informant version of the derived Dutch version, the PID-5-Brief form+Modified. This version consists of 36 self-report items (all part of the original PID-5) and covers a combination of the five Diagnostic and Statistical Manual of Mental disorders edition 5 domains and the Internation Classification of diseases edition 11 personality trait domain Anankastic, resulting in six domains.

Once before the start of the CoMBI-SMI training.
Level of Personality Functioning-scale brief form 2.0
Časové okno: Once before the start of the CoMBI-SMI training.

The LPFS-brief form 2.0 measures the level of personality functioning as described in the Diagnostic and Statistical Manual of mental Disorders with items for the four domains of personality functioning (identity, self-direction, empathy and intimacy) (Rossi et al., 2019). There are three items for each of the four domains, resulting in 12 items.The items measure the four domains of Criterion A to determine the severity of the personality disorder. It is a self-report questionnaire originally developed in Dutch. There is also an informant version. A preliminary study in a clinical sample including younger adults found evidence for a factor structure of two overarching factors, self and interpersonal functioning, that showed relevant associations with different severity measures. In addition, the LPFS-Brief form 2.0 has been shown to have good convergent validity in older adults in a clinical sample.

Once before the start of the CoMBI-SMI training.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Vyšetřovatelé

  • Vrchní vyšetřovatel: Saskia Bollen, Vrije Universiteit Brussel

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

28. dubna 2023

Primární dokončení (Aktuální)

1. března 2024

Dokončení studie (Aktuální)

26. března 2024

Termíny zápisu do studia

První předloženo

7. dubna 2023

První předloženo, které splnilo kritéria kontroly kvality

7. dubna 2023

První zveřejněno (Aktuální)

19. dubna 2023

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

30. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

26. září 2026

Naposledy ověřeno

1. března 2023

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • CoMBI-SMI

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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