Mental Illness PersistentCoMBI-SMINCT07006623
"CoMBI-SMI Multicenter Study: A Person-Centered Cognitive-Behavioral Intervention for Severe Mental Illness"
A study testing CoMBI-SMI in people with Mental Illness Persistent, run by Vrije Universiteit Brussel at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Illness Persistent
- What is being tested?
- CoMBI-SMI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2025to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diagnosis of dementia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Mondriaan
Heerlen, Limburg, 6419PJ
Saskia Bollen, 0031643732363, saskiabollen80@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Mental Illness Persistent
- Being tested
- CoMBI-SMI
- Keywords
- Severe mental illness, older adults, adults, mediationtherapie, Cognitive behavioral therapie, Nursing interventions
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoMBI-SMIBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: CoMBI-SMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Aug 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Illness PersistentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Mondriaan
- Responsible party
- Principal investigator, Saskia Bollen, Vrije Universiteit Brussel
- Investigators
- van Alphen, Prof. dr., Principal investigator, Mondriaan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006623
- Sponsor's protocol ID
- METCZ20250033
- Other IDs
- projectnr 330
- Acronym
- CoMBI-SMI
- Status last verified
- Jun 2025
- First submitted
- 27 May 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07006623
- Acronym / sponsor ID
- CoMBI-SMI / METCZ20250033
- Conditions
- Mental Illness Persistent
- Keywords
- Severe mental illness, older adults, adults, mediationtherapie, Cognitive behavioral therapie, Nursing interventions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Collaborators
- Mondriaan
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CoMBI-SMI | Experimental | Behavioral: CoMBI-SMIThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Diagnosis of dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoMBI-SMICoMBI-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. | Behavioural | CoMBI-SMI |
Primary outcome
Neuropsychiatric Inventory - Questionnaire (NPI-Q): Symptom Severity and Caregiver Distress Scores
Time frame: 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
Time frame: 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.
1 secondary outcome
Mental Health Quality of Life (MHQoL-7D): Total Score and Visual Analogue Scale (VAS)
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
van Alphen, Prof. dr. principal investigator
Mondriaan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoMBI-SMI in people with Mental Illness Persistent, run by Vrije Universiteit Brussel at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saskia Bollen, MSc (0031643732363, saskia.bollen@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychiatric Inventory - Questionnaire (NPI-Q): Symptom Severity and Caregiver Distress Scores (time frame: 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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.