Community-based Occupational Therapy Intervention on Mental Health for People With Acquired Brain Injury (COT-MHABI)

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.

Study Overview

• Status: Recruiting
• Conditions: Acquired Brain Injury; Mental Health Issue
• Intervention / Treatment: Behavioral: Community-based Occupational Therapy; Behavioral: Standard community-based intervention

• Study Type: Interventional
• Enrollment (Anticipated): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marco A Raya-Ruiz; Phone Number: 2273 +34934977700; Email: maraya@guttmann.com
• Study Contact Backup: Name: Beatriz Castaño-Monsalve; Phone Number: 3225 +34934977700; Email: bcastano@guttmann.com

Study Locations

• Spain
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Recruiting
      • Institut Guttmann Neurorehabilitation Hospital
      • Contact: Beatriz Castaño-Monsalve; Phone Number: 3225 +34934977700; Email: bcastano@guttmann.com
      • Principal Investigator: Marco A Raya-Ruiz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Community-based Occupational Therapy; 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.	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.
ACTIVE_COMPARATOR: Standard community-based intervention; Control group of the study that will receive community-based interventions, public or private level (e.g. community nursing, social education and/or psychology).	Behavioral: Standard community-based intervention; Interventions received at the community, public or private level (e.g. community nursing, social education and/or psychology).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Institut Guttmann
• Collaborators: University of Vic - Central University of Catalonia
• Investigators: Study Director: José A Merchán-Baeza, University of Vic-UCC

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2020
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (ACTUAL): October 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: 252136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No