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

NCT07006623 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2025-06-15

No results posted yet for this study

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

Interventions

BEHAVIORAL

CoMBI-SMI

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.

Sponsors & Collaborators

  • Mondriaan

    collaborator UNKNOWN

  • Vrije Universiteit Brussel

    lead OTHER

Principal Investigators

  • van Alphen, Prof. dr. · Mondriaan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2029-08-31
Completion
2029-09-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07006623 on ClinicalTrials.gov