Clinical trial NCT04586842: Community-based Occupational Therapy Intervention on Mental Health for People With Acquired Brain Injury
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acquired Brain Injury
Mental Health Issue
Lead sponsor: Institut Guttmann
Sponsor class: OTHER
Collaborators: name: University of Vic - Central University of Catalonia
First posted: 2020-10-14
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: World Health Organization Quality of Life-BREF, spanish version (WHOQoL-BREF)
timeFrame: 1 year
measure: Canadian Occupational Performance Measure, spanish version (COPM)
timeFrame: 1 year
Secondary outcomes:
measure: Community Integration Questionnaire, spanish version (CIQ)
timeFrame: 1 year
measure: Activity Card Sort, spanish version (ACS)
timeFrame: 1 year
measure: Satisfaction with Daily Occupations and Occupational Balance, spanish version (SOD-EO)
timeFrame: 1 year
measure: Role Checklist Version 3 (RCV3)
timeFrame: 1 year
measure: Functional Independence Measure (FIM)
timeFrame: 1 year
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Institut Guttmann Neurorehabilitation Hospital
state: Barcelona
Study officials:
affiliation: University of Vic-UCC
name: José A Merchán-Baeza
role: STUDY_DIRECTOR
References:
citation: 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.