Cognitive Model for Behavioral Interventions as a Personalized Intervention for Patients With Serious Mental Illness
NCT ID: NCT05820360
Last Updated: 2023-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2023-04-30
2024-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
CoMBI-SMI
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.
Interventions
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CoMBI-SMI
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.
Eligibility Criteria
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Inclusion Criteria
* presence of SMI and behavioral problems
* willingness and ability to participate in this study.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Vrije Universiteit Brussel
OTHER
Responsible Party
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Saskia Bollen
Principal Investigator
Principal Investigators
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Saskia Bollen
Role: PRINCIPAL_INVESTIGATOR
Vrije Universiteit Brussel
Central Contacts
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References
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Kaufer DI, Cummings JL, Ketchel P, Smith V, MacMillan A, Shelley T, Lopez OL, DeKosky ST. Validation of the NPI-Q, a brief clinical form of the Neuropsychiatric Inventory. J Neuropsychiatry Clin Neurosci. 2000 Spring;12(2):233-9. doi: 10.1176/jnp.12.2.233.
Kat MG, de Jonghe JF, Aalten P, Kalisvaart CJ, Droes RM, Verhey FR. [Neuropsychiatric symptoms of dementia: psychometric aspects of the Dutch Neuropsychiatric Inventory (NPI)]. Tijdschr Gerontol Geriatr. 2002 Sep;33(4):150-5. Dutch.
de Beurs E, den Hollander-Gijsman ME, van Rood YR, van der Wee NJ, Giltay EJ, van Noorden MS, van der Lem R, van Fenema E, Zitman FG. Routine outcome monitoring in the Netherlands: practical experiences with a web-based strategy for the assessment of treatment outcome in clinical practice. Clin Psychol Psychother. 2011 Jan-Feb;18(1):1-12. doi: 10.1002/cpp.696.
van Krugten FCW, Busschbach JJV, Versteegh MM, Hakkaart-van Roijen L, Brouwer WBF. The Mental Health Quality of Life Questionnaire (MHQoL): development and first psychometric evaluation of a new measure to assess quality of life in people with mental health problems. Qual Life Res. 2022 Feb;31(2):633-643. doi: 10.1007/s11136-021-02935-w. Epub 2021 Jul 9.
Krueger RF, Derringer J, Markon KE, Watson D, Skodol AE. Initial construction of a maladaptive personality trait model and inventory for DSM-5. Psychol Med. 2012 Sep;42(9):1879-90. doi: 10.1017/S0033291711002674. Epub 2011 Dec 8.
Anderson JL, Sellbom M. Evaluating the DSM-5 Section III personality disorder impairment criteria. Personal Disord. 2018 Jan;9(1):51-61. doi: 10.1037/per0000217. Epub 2016 Sep 12.
Osterloh JWSA, Videler AC, Rossi GMP, van Alphen SPJ. [Cognitive model for behavioural interventions for personality disorders in older adults: a nursing approach]. Tijdschr Gerontol Geriatr. 2018 Oct;49(5):210-212. doi: 10.1007/s12439-018-0256-6. Epub 2018 Jul 31. Dutch.
Bach B, Hutsebaut J. Level of Personality Functioning Scale-Brief Form 2.0: Utility in Capturing Personality Problems in Psychiatric Outpatients and Incarcerated Addicts. J Pers Assess. 2018 Nov-Dec;100(6):660-670. doi: 10.1080/00223891.2018.1428984. Epub 2018 Mar 1.
Rossi, G., Debast, I., Berghuis, H., Ingenhoven, T. J. M., van der Heijden, P., & Morey, L. (2019).Nederlandstalige vertaling van de niveaus van persoonlijkheidsfunctioneren zelfrapportage schaal (Level ofPersonality Functioning Scale-Self Report; LPFS-SR).
Other Identifiers
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CoMBI-SMI
Identifier Type: -
Identifier Source: org_study_id
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