Cognitive Model for Behavioral Interventions as a Personalized Intervention for Patients With Serious Mental Illness

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cognitive Model for Behavioral Interventions (CoMBI) as a Personalized Behavioral Intervention for Patients With Serious Mental Illness

Conditions
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Psychiatric Disorder

Intervention / Treatment
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* Behavioral: CoMBI-SMI


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Model Description:
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: People with Serious Mental Illness<br>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. | Behavioral: CoMBI-SMI<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychiatric Inventory - Questionnaire (NPI-Q) | 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) | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental Health Quality of Life (MHQoL-7D) | 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 |