This observational multicenter study aims to evaluate whether the Cognitive Model for Behavioral Interventions - Severe Mental Illness (CoMBI-SMI) can reduce challenging behaviors and psychological symptoms in adults (aged 18 and older) with severe mental illness (SMI). The study is conducted across multiple sites in the Netherlands, Belgium, and the Caribbean, using a stepped-wedge design. All participating departments initially continue their usual care. At different time points, each team receives training in the CoMBI-SMI approach and begins implementing the intervention. This design allows for a comparison between standard care and CoMBI-SMI-based care.
Participants first receive their usual treatment, during which baseline data are collected on their behavior and psychological symptoms. After the care team is trained in CoMBI-SMI, participants receive CoMBI-SMI-based care for four weeks. They complete questionnaires on behavior, psychological symptoms, and quality of life before and after the intervention. The study aims to assess whether CoMBI-SMI helps reduce challenging behaviors such as aggression or repetitive actions, improve quality of life, and reduce stress for both caregivers and treatment teams. Findings from this study may help improve care for individuals with severe mental illness and provide better support for mental health professionals managing complex behaviors.
Psychogeriatric inpatients aged 18 years and older
Clinical diagnosis of a severe mental illness (SMI)
Presence of behavioral problems not understood by caregivers
Willingness and ability to participate in the study
None
Single group
CoMBI-SMI
BehavioralCoMBI-SMI (Cognitive Model for Behavioral Interventions - Severe Mental Illness) is a structured, team-based behavioral intervention for individuals with severe mental illness. It consists of four steps: (1) analyzing misunderstood behavior and identifying unmet core needs, (2) selecting the most relevant core need, (3) choosing appropriate nursing interventions, and (4) developing a CoMBI care plan. The model is based on cognitive-behavioral principles and personality-based formulations grounded in the DSM. It describes self-image, perception of others, triggers, and problematic behaviors. CoMBI-SMI is implemented by the entire team in a cyclical process, with periodic evaluation and a focus on consistent, team-aligned strategies.
Neuropsychiatric Inventory - Questionnaire (NPI-Q): Symptom Severity and Caregiver Distress Scores
The NPI-Q is a validated 12-item questionnaire used to assess neuropsychiatric symptoms and associated caregiver distress. The questionnaire is completed by an informal caregiver and evaluates whether specific symptoms are present, the severity of each symptom (rated on a 3-point scale from 1 = mild to 3 = severe), and the emotional distress it causes the caregiver (rated on a 6-point scale from 0 = not at all distressing to 5 = extremely distressing). Higher scores indicate more severe symptoms and greater caregiver distress. Total scores for symptom severity range from 0 to 36, and for caregiver distress from 0 to 60.
Brief Symptom Inventory (BSI): Total Symptom Severity Score
The Brief Symptom Inventory (BSI) is a 53-item self-report questionnaire used to assess psychological and somatic symptom severity over the past week. Items are scored on a 5-point Likert scale ranging from 0 = "not at all" to 4 = "extremely." The instrument yields scores for nine subscales (Somatization, Cognitive Problems, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism), as well as a Global Severity Index (GSI), which reflects overall symptom severity. Higher scores indicate more severe psychological distress. The GSI score ranges from 0 to 4. The BSI is validated for use in clinical and general populations and has been standardized for the Dutch language area, with norm data for men and women in both clinical and non-clinical samples.
Mental Health Quality of Life (MHQoL-7D): Total Score and Visual Analogue Scale (VAS)
The Mental Health Quality of Life (MHQoL-7D) is a standardized self-report instrument designed to assess quality of life in individuals with mental health conditions. It consists of two components: (1) the MHQoL-7D descriptive section, comprising seven dimensions (self-esteem, independence, mood, relationships, daily activities, physical health, and future), each scored on a 4-point scale from 0 = "very dissatisfied" to 3 = "very satisfied"; and (2) a visual analogue scale (VAS) that measures overall psychological well-being on a scale from 0 = "the worst imaginable psychological well-being" to 10 = "the best imaginable psychological well-being." Total scores on the MHQoL-7D range from 0 to 21, with higher scores indicating better quality of life. The VAS provides a single-item global rating of subjective mental health.
Personality Inventory for DSM-5 - Brief Form Plus Modified (PID-5-BF+Modified): Domain Scores
The Personality Inventory for DSM-5 - Brief Form Plus Modified (PID-5-BF+Modified) is a 36-item self-report questionnaire derived from the original 220-item PID-5. It assesses maladaptive personality traits across six domains: Negative Affectivity, Detachment, Antagonism, Disinhibition, Psychoticism (from DSM-5), and Anankastia (from ICD-11). Items are scored on a 4-point Likert scale ranging from 0 = "very false or often false" to 3 = "very true or often true." Each domain score is calculated as the mean of its respective items. Higher scores indicate greater expression of maladaptive personality traits. Each domain score ranges from 0 to 3. The PID-5-BF+Modified will be used in both self-report and informant-report formats to explore associations between personality pathology and intervention outcomes.
Level of Personality Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0): Total Score and Domain Scores
The Level of Personality Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0) is a 12-item self-report questionnaire that assesses the severity of personality dysfunction, in line with Criterion A of the Alternative Model for Personality Disorders (DSM-5). It covers four domains of personality functioning: Identity, Self-Direction, Empathy, and Intimacy. Each domain is represented by three items. Items are scored on a 5-point Likert scale ranging from 0 = "completely false" to 4 = "completely true." Domain scores are calculated as the mean of the corresponding three items. The total score is the mean of all 12 items and ranges from 0 to 4. Higher scores indicate greater impairment in personality functioning. The LPFS-BF 2.0 will be administered in self-report and informant-report formats to assess baseline levels of personality dysfunction.
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Vrije Universiteit Brussel
Lead sponsor
Mondriaan
Collaborator
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