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

Mental Health Issue Clinical Trial

— COT-MHABI  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04586842
• Other study ID #: 252136
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 2022

Study information

• Verified date: July 2022
• Source: Institut Guttmann
• Contact: Marco A Raya-Ruiz
• Phone: +34934977700
• Email: maraya[@]guttmann.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: September 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Mental Health Issue
• Wounds and Injuries

Intervention

Behavioral:
• Community-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.
• Standard community-based intervention
Interventions received at the community, public or private level (e.g. community nursing, social education and/or psychology).

Locations

Country	Name	City	State
Spain	Institut Guttmann Neurorehabilitation Hospital	Badalona	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Institut Guttmann	University of Vic - Central University of Catalonia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	World Health Organization Quality of Life-BREF, spanish version (WHOQoL-BREF)	This scale provides a profile of quality of life perceived by the subject.	1 year
Primary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	Role Checklist Version 3 (RCV3)	An occupational therapy measure that provides information about the participation and satisfaction with performance in desired and meaningful roles.	1 year
Secondary	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.	1 year