Clinical trial NCT05820360: Cognitive Model for Behavioral Interventions as a Personalized Intervention for Patients With Serious Mental Illness
Official title: Cognitive Model for Behavioral Interventions (CoMBI) as a Personalized Behavioral Intervention for Patients With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychiatric Disorder
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Model Description:
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Neuropsychiatric Inventory - Questionnaire (NPI-Q)
timeFrame: Before the start of TAU, before the CoMBI-SMI training and after 4 weeks of CoMBI-SMI-training
measure: Brief Symptom Inventory (BSI)
timeFrame: Before the start of TAU, before the CoMBI-SMI training and after 4 weeks of CoMBI-SMI-training
Secondary outcomes:
measure: Mental Health Quality of Life (MHQoL-7D)
timeFrame: Before the start of TAU, before the CoMBI-SMI training and after 4 weeks of CoMBI-SMI-training
Other outcomes:
measure: Personality Inventory for Diagnostic and Statistical Manual of Mental Disorders edition 5 (PID-5-BF+Modified)
timeFrame: Once before the start of the CoMBI-SMI training.
measure: Level of Personality Functioning-scale brief form 2.0
timeFrame: Once before the start of the CoMBI-SMI training.
Locations:
Study officials:
affiliation: Vrije Universiteit Brussel
name: Saskia Bollen
role: PRINCIPAL_INVESTIGATOR
References:
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