"CoMBI-SMI Multicenter Study: A Person-Centered Cognitive-Behavioral Intervention for Severe Mental Illness"

NCT07006623 | Not Yet Recruiting

• 2 other identifiers: METCZ20250033projectnr 330
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Illness Persistent

Keywords

Severe mental illness; older adults; adults; mediationtherapie; Cognitive behavioral therapie; Nursing interventions

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

• 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.

  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 (1)

• 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).

Other Outcomes (2)

• Personality Inventory for DSM-5 - Brief Form Plus Modified (PID-5-BF+Modified): Domain Scores

  Once, immediately before the start of CoMBI-SMI training

• Level of Personality Functioning Scale - Brief Form 2.0 (LPFS-BF 2.0): Total Score and Domain Scores

  Once, immediately before the start of CoMBI-SMI training

Study Arms (1)

CoMBI-SMI

EXPERIMENTAL

This study arm includes adults (aged 18-64 years) and older adults (aged 65 years and older) with a severe mental illness (SMI). Participants must meet the inclusion criteria of having a diagnosed SMI and exhibiting behavior that is not well understood by caregivers. Additional inclusion criteria are the willingness and ability to participate in the study procedures. Participants in this arm will receive the CoMBI-SMI intervention following a period of treatment as usual.

Behavioral: CoMBI-SMI

Interventions

CoMBI-SMI BEHAVIORAL

CoMBI-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.

CoMBI-SMI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Diagnosis of dementia

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• Mondriaan: collaborator

Study Sites (1)

Mondriaan

Heerlen, Limburg, 6419PJ, Netherlands

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

• van Alphen, Prof. dr.

  Mondriaan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saskia Bollen, MSc

CONTACT

0031643732363; saskia.bollen@vub.be

Gina Rossi, Prof. dr.

CONTACT

0032476721678; gina.rossi@vub.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hoofdonderzoeker

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 5, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)