Acquired Brain InjuryCOT-MHABINCT04586842
Community-based Occupational Therapy Intervention on Mental Health for People With Acquired Brain Injury
A study testing Community-based Occupational Therapy and Standard community-based intervention in people with Acquired Brain Injury and Mental Health Issue, run by Institut Guttmann at 1 site in Spain.
Trial summary
The main purpose of this research project is to analyze the effectiveness of a Community-based Occupational Therapy Intervention on mental health for people with acquired brain injury. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acquired Brain Injury, Mental Health Issue
- What is being tested?
- Community-based Occupational Therapy and Standard community-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2020to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with a diagnosis of medium or severe ABI and a diagnosis of neurocognitive disorder following ABI (as recognised in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); by definition: evidence of significant cognitive decline from pre-ABI level in one or more cognitive domains (attention, executive function, learning and memory, perceptual-motor ability or social cognition).
- It may occur with or without behavioural impairment (apathy, mood disturbance, irritability, disinhibition, psychotic symptoms, etc.)).
- This population (A) show difficulties in occupational participation with respect to the pre-ABI situation and present needs for support, counselling and/or specific therapeutic intervention; (B) are in a situation of hospital discharge from ABI specialisation units; (C) are domiciled in the same province to which the providing hospital belongs. In addition, they may or may not have been diagnosed with a mental health disorder other than neurocognitive disorder, either prior or subsequent to the ABI.
Who cannot join
- Persons will be excluded if (A) they are in a situation of symptomatological destabilisation of severe functional impairment that, as a priority, requires continued support from specialised mental health units, psychiatric or social-health care admission; and/or (B) they are unable to determine for themselves (for cognitive reasons or by conscious choice) any problem in at least one occupational area.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Institut Guttmann Neurorehabilitation Hospital
Badalona, Barcelona, 08916
Beatriz Castaño-Monsalve, +34934977700 ext. 3225, bcastano@guttmann.com
Marco A Raya-Ruiz
About this study
Official title: Study Protocol For A Non-Randomised Controlled Trial: A Community-Based Occupational Therapy Intervention On Mental Health For People With Acquired Brain Injury (COT-MHABI)
The main purpose of this research project is to analyze the effectiveness of a Community-based Occupational Therapy Intervention on mental health for people with acquired brain injury. To this end, variables such as quality of life, occupational performance and balance, participation in significant roles and community integration will be measured.
The research will be carried out as a non-randomized controlled trial study in which the participants in the experimental arm will receive a community-based occupational therapy intervention (domiciliary and telehealth intervention sessions) based on the stages of the Human Occupation Model's Remotivation Process. The participants at the control arm will receive the regular (public or private) services provision for this population profile.
It is expected to be able to demonstrate the effectiveness of the intervention based on a positive result in the change in the variables, so as to increase the chance and performance of occupational participation after the acquired brain injury. Also, it is intended that families and the community are key elements of agency and support in occupational participation.
- Conditions
- Acquired Brain Injury, Mental Health Issue
- Being tested
- Community-based Occupational Therapy, Standard community-based intervention
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based Occupational TherapyBehavioural
Domiciliary and Community-based Occupational Therapy on mental health and ABI intervention, developed on the basis of the Model Of Human Occupation.
Standard community-based interventionBehavioural
Interventions received at the community, public or private level (e.g. community nursing, social education and/or psychology).
| Study group | Role | What they receive |
|---|---|---|
| Community-based Occupational Therapy | Experimental | Experimental study group that will receive a domiciliary and community-based occupational therapy on mental health, developed on the basis of the Model Of Human Occupation. Receives: Behavioral: Community-based Occupational Therapy |
| Standard community-based intervention | Active comparator | Control group of the study that will receive community-based interventions, public or private level (e.g. community nursing, social education and/or psychology). Receives: Behavioral: Standard community-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
World Health Organization Quality of Life-BREF, spanish version (WHOQoL-BREF)
This scale provides a profile of quality of life perceived by the subject.
Measured: 1 year
Canadian Occupational Performance Measure, spanish version (COPM)
This scale is an evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time.
Measured: 1 year
Secondary outcomes (5)
Community Integration Questionnaire, spanish version (CIQ)
Provides the measure of an individual's level of integration into the home and community following traumatic brain injury.
Measured: 1 year
Activity Card Sort, spanish version (ACS)
An Occupational Therapy scale that measures the level of participation perceived by the person through the use of photographs that reflect everyday activities.
Measured: 1 year
Satisfaction with Daily Occupations and Occupational Balance, spanish version (SOD-EO)
An occupational therapy measure that provides information about the activity level of the subject, occupational satisfaction with his/her performance and self-perception of occupational balance.
Measured: 1 year
Role Checklist Version 3 (RCV3)
An occupational therapy measure that provides information about the participation and satisfaction with performance in desired and meaningful roles.
Measured: 1 year
Functional Independence Measure (FIM)
The scale represents a uniform measurement system for functional independence based on the International Classification of Impairment, Disabilities and Handicaps. It assesses six functional areas (self-care, sphincter control, transfers, locomotion, communication and social cognition) within two domains (motor and cognitive). Each item is scored on a 7-point Likert-type scale. The items are performance-based rather than ability-based and are recorded in a hetero-administered manner.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Sep 2020
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acquired Brain InjuryStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Guttmann
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vic - Central University of Catalonia
- Responsible party
- Sponsor
- Investigators
- José A Merchán-Baeza, Study director, University of Vic-UCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586842
- Sponsor's protocol ID
- 252136
- Acronym
- COT-MHABI
- Status last verified
- Jul 2022
- First submitted
- 21 Jul 2020
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raya-Ruiz MA, Rodriguez-Bailon M, Castano-Monsalve B, Vidana-Moya L, Fernandez-Solano AJ, Merchan-Baeza JA. Study protocol for a non-randomised controlled trial: Community-based occupational therapy intervention on mental health for people with acquired brain injury (COT-MHABI). PLoS One. 2022 Oct 7;17(10):e0274193. doi: 10.1371/journal.pone.0274193. eCollection 2022.
PubMed 36206208
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Protocol For A Non-Randomised Controlled Trial: A Community-Based Occupational Therapy Intervention On Mental Health For People With Acquired Brain Injury (COT-MHABI)
- ClinicalTrials.gov ID
- NCT04586842
- Acronym / sponsor ID
- COT-MHABI / 252136
- Conditions
- Acquired Brain Injury, Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Institut GuttmannUniversity, hospital or other
- Collaborators
- University of Vic - Central University of Catalonia
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 14 Oct 2020 (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.
The main purpose of this research project is to analyze the effectiveness of a Community-based Occupational Therapy Intervention on mental health for people with acquired brain injury. To this end, variables such as quality of life, occupational performance and balance, participation in significant roles and community integration will be measured.
The research will be carried out as a non-randomized controlled trial study in which the participants in the experimental arm will receive a community-based occupational therapy intervention (domiciliary and telehealth intervention sessions) based on the stages of the Human Occupation Model's Remotivation Process. The participants at the control arm will receive the regular (public or private) services provision for this population profile.
It is expected to be able to demonstrate the effectiveness of the intervention based on a positive result in the change in the variables, so as to increase the chance and performance of occupational participation after the acquired brain injury. Also, it is intended that families and the community are key elements of agency and support in occupational participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community-based Occupational Therapy | Experimental | Behavioral: Community-based Occupational TherapyExperimental study group that will receive a domiciliary and community-based occupational therapy on mental health, developed on the basis of the Model Of Human Occupation. |
| Standard community-based intervention | Active comparator | Behavioral: Standard community-based interventionControl group of the study that will receive community-based interventions, public or private level (e.g. community nursing, social education and/or psychology). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults with a diagnosis of medium or severe ABI and a diagnosis of neurocognitive disorder following ABI (as recognised in the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); by definition: evidence of significant cognitive decline from pre-ABI level in one or more cognitive domains (attention, executive function, learning and memory, perceptual-motor ability or social cognition).
- It may occur with or without behavioural impairment (apathy, mood disturbance, irritability, disinhibition, psychotic symptoms, etc.)).
- This population (A) show difficulties in occupational participation with respect to the pre-ABI situation and present needs for support, counselling and/or specific therapeutic intervention; (B) are in a situation of hospital discharge from ABI specialisation units; (C) are domiciled in the same province to which the providing hospital belongs. In addition, they may or may not have been diagnosed with a mental health disorder other than neurocognitive disorder, either prior or subsequent to the ABI.
Key exclusion criteria (1 listed)
- Persons will be excluded if (A) they are in a situation of symptomatological destabilisation of severe functional impairment that, as a priority, requires continued support from specialised mental health units, psychiatric or social-health care admission; and/or (B) they are unable to determine for themselves (for cognitive reasons or by conscious choice) any problem in at least one occupational area.
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 |
|---|---|---|
| Community-based Occupational TherapyDomiciliary and Community-based Occupational Therapy on mental health and ABI intervention, developed on the basis of the Model Of Human Occupation. | Behavioural | Community-based Occupational Therapy |
| Standard community-based interventionInterventions received at the community, public or private level (e.g. community nursing, social education and/or psychology). | Behavioural | Standard community-based intervention |
Primary outcome
World Health Organization Quality of Life-BREF, spanish version (WHOQoL-BREF)
Time frame: 1 year
This scale provides a profile of quality of life perceived by the subject.
Canadian Occupational Performance Measure, spanish version (COPM)
Time frame: 1 year
This scale is an evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time.
5 secondary outcomes
Community Integration Questionnaire, spanish version (CIQ)
Time frame: 1 year
Activity Card Sort, spanish version (ACS)
Time frame: 1 year
Satisfaction with Daily Occupations and Occupational Balance, spanish version (SOD-EO)
Time frame: 1 year
Role Checklist Version 3 (RCV3)
Time frame: 1 year
Functional Independence Measure (FIM)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Derived from this study: PubMed 36206208Raya-Ruiz MA, Rodriguez-Bailon M, Castano-Monsalve B, Vidana-Moya L, Fernandez-Solano AJ, Merchan-Baeza JA. Study protocol for a non-randomised controlled trial: Community-based occupational therapy intervention on mental health for people with acquired brain injury (COT-MHABI). PLoS One. 2022 Oct 7;17(10):e0274193. doi: 10.1371/journal.pone.0274193. eCollection 2022.
- Individual participant dataSharing planned: No
Related trials for Acquired Brain Injury
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Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
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RecruitingObservational study
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Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
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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. This study is not recruiting at the moment.
José A Merchán-Baeza study director
University of Vic-UCC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community-based Occupational Therapy and Standard community-based intervention in people with Acquired Brain Injury and Mental Health Issue, run by Institut Guttmann at 1 site in Spain.
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 3 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: status not confirmed, as of the sponsor's last update on 19 Jul 2022. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco A Raya-Ruiz (+34934977700 ext. 2273, maraya@guttmann.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
World Health Organization Quality of Life-BREF, spanish version (WHOQoL-BREF) (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT04586842, which also lists 1 linked publication.
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 19 Jul 2022.