Skip to content

Community-based Occupational Therapy Intervention on Mental Health for People With Acquired Brain Injury

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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04586842
Acronym
COT-MHABI
Enrollment
134
Registered
2020-10-14
Start date
2020-09-01
Completion date
2022-09-30
Last updated
2022-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Brain Injury, Mental Health Issue

Brief 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. 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.

Interventions

BEHAVIORALCommunity-based Occupational Therapy

Domiciliary and Community-based Occupational Therapy on mental health and ABI intervention, developed on the basis of the Model Of Human Occupation.

BEHAVIORALStandard community-based intervention

Interventions received at the community, public or private level (e.g. community nursing, social education and/or psychology).

Sponsors

University of Vic - Central University of Catalonia
CollaboratorOTHER
Institut Guttmann
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
World Health Organization Quality of Life-BREF, spanish version (WHOQoL-BREF)1 yearThis scale provides a profile of quality of life perceived by the subject.
Canadian Occupational Performance Measure, spanish version (COPM)1 yearThis scale is an evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time.

Secondary

MeasureTime frameDescription
Satisfaction with Daily Occupations and Occupational Balance, spanish version (SOD-EO)1 yearAn 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.
Community Integration Questionnaire, spanish version (CIQ)1 yearProvides the measure of an individual's level of integration into the home and community following traumatic brain injury.
Functional Independence Measure (FIM)1 yearThe 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.
Role Checklist Version 3 (RCV3)1 yearAn occupational therapy measure that provides information about the participation and satisfaction with performance in desired and meaningful roles.
Activity Card Sort, spanish version (ACS)1 yearAn Occupational Therapy scale that measures the level of participation perceived by the person through the use of photographs that reflect everyday activities.

Countries

Spain

Contacts

Primary ContactMarco A Raya-Ruiz
maraya@guttmann.com+34934977700
Backup ContactBeatriz Castaño-Monsalve
bcastano@guttmann.com+34934977700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026