Clinical trial NCT07006623: "CoMBI-SMI Multicenter Study: A Person-Centered Cognitive-Behavioral Intervention for Severe Mental Illness"
Official title: A Multicenter Study of the Cognitive Model for Behavioral Interventions (CoMBI) as a Personalized Cognitive Behavioral Intervention for Patients With Severe Mental Illness
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mental Illness Persistent
Keywords: Severe mental illness
older adults
adults
mediationtherapie
Cognitive behavioral therapie
Nursing interventions
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
Collaborators: name: Mondriaan
First posted: 2025-06-05
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Healthcare providers in participating departments will be trained in the CoMBI-SMI protocol. Training consists of an online theoretical module followed by a Meet-the-Expert (MTE) session, where providers can discuss theory and practice the application of CoMBI-SMI using clinical case studies. Completion of the training requires passing case-based assessments that evaluate theoretical understanding and clinical reasoning.

This study aims to improve behavioral management in SMI, enhance team competence in dealing with complex behaviors, and contribute to the development of structured, theory-based protocols for mediation therapy in psychiatry.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

- Diagnosis of dementia

Primary outcomes:
measure: Neuropsychiatric Inventory - Questionnaire (NPI-Q): Symptom Severity and Caregiver Distress Scores
timeFrame: 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)
measure: Brief Symptom Inventory (BSI): Total Symptom Severity Score
timeFrame: 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)
Secondary outcomes:
measure: Mental Health Quality of Life (MHQoL-7D): Total Score and Visual Analogue Scale (VAS)
timeFrame: 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).
Other outcomes:
measure: Personality Inventory for DSM-5 - Brief Form Plus Modified (PID-5-BF+Modified): Domain Scores
timeFrame: Once, immediately before the start of CoMBI-SMI training
measure: Level of Personality Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0): Total Score and Domain Scores
timeFrame: Once, immediately before the start of CoMBI-SMI training
Locations:
city: Heerlen
country: Netherlands
facility: Mondriaan
state: Limburg
Study officials:
affiliation: Mondriaan
name: van Alphen, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: