A Multicenter Study of the Cognitive Model for Behavioral Interventions (CoMBI) as a Personalized Cognitive Behavioral Intervention for Patients With Severe Mental Illness
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Neuropsychiatric Inventory - Questionnaire (NPI-Q): Symptom Severity and Caregiver Distress Scores
研究概览
简要总结
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.
详细描述
This multicenter observational study investigates the effectiveness of a treatment protocol for a personalized approach to behavioral problems in individuals with severe mental illness (SMI), grounded in patients' core psychological needs derived from their specific personality traits. Participants will be recruited from specialized mental health care institutions in the Netherlands, Belgium, and the Caribbean. Both adults (aged 18-64 years) and older adults (≥65 years) with SMI will be included.
The study employs a stepped-wedge design, where all participating teams initially provide treatment as usual (TAU), with outcome measurements every four weeks. At staggered time points, teams will be trained in the CoMBI-SMI intervention and transition to providing care based on this model. CoMBI-SMI (Cognitive Model for Behavioral Interventions - Severe Mental Illness) is a mediation-based approach in which behavioral interventions are implemented through a multidisciplinary team, rather than individual therapy. This model is particularly suited for the SMI population, where direct psychotherapy is often unfeasible due to lack of motivation or cognitive limitations.
The CoMBI-SMI intervention is based on Beck's cognitive model of personality disorders and integrates structured nursing interventions from the Nursing Interventions Classification (NIC). The intervention begins with the identification of maladaptive behavior patterns by the care team. These behaviors are analyzed in terms of their environmental triggers and maintaining consequences. A relevant core need is then selected from the CoMBI-SMI framework, and corresponding team-based interventions are planned. These are documented in a CoMBI care plan and implemented in a cyclical, evaluation-based format.
Primary outcome measures are the Neuropsychiatric Inventory Questionnaire (NPI-Q), assessing behavioral symptoms and associated distress, and the Brief Symptom Inventory (BSI), measuring psychological symptom severity. Secondary outcomes include perceived caregiver burden (NPI-Q distress scores) and patient-reported quality of life, measured by the Mental Health Quality of Life scale (MHQoL-7D). In addition, the study will identify predictive factors for treatment response using personality assessment tools: the Personality Inventory for DSM-5 - Brief Form + Modified (PID-5-BF+M) and the Level of Personality Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0).
The NPI-Q data will also be used for a validation substudy in the SMI population, evaluating the instrument's construct validity, internal consistency, and inter-rater reliability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Diagnosis of dementia
结局指标
主要结局
Neuropsychiatric Inventory - Questionnaire (NPI-Q): Symptom Severity and Caregiver Distress Scores
时间窗: At baseline (before the start of treatment-as-usual) Immediately before the start of CoMBI-SMI training At week 5 (after 4 weeks of CoMBI-SMI-based care)
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
时间窗: At baseline (before the start of treatment-as-usual) Immediately before the start of CoMBI-SMI training At week 5 (after 4 weeks of CoMBI-SMI-based care)
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.
次要结局
- Mental Health Quality of Life (MHQoL-7D): Total Score and Visual Analogue Scale (VAS)(At baseline (before the start of treatment-as-usual) Immediately before the start of CoMBI-SMI training At week 5 (after 4 weeks of CoMBI-SMI-based care).)
研究者
Saskia Bollen
Hoofdonderzoeker
Vrije Universiteit Brussel