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

NCT04586842 | Unknown

• 1 other identifier: 252136
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Brain Injury; Mental Health Issue

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Community Integration Questionnaire, spanish version (CIQ)

  1 year

• Activity Card Sort, spanish version (ACS)

  1 year

• Satisfaction with Daily Occupations and Occupational Balance, spanish version (SOD-EO)

  1 year

• Role Checklist Version 3 (RCV3)

  1 year

• Functional Independence Measure (FIM)

  1 year

Study Arms (2)

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.

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).

Behavioral: Standard community-based intervention

Interventions

Community-based Occupational Therapy BEHAVIORAL

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

Community-based Occupational Therapy

Standard community-based intervention BEHAVIORAL

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

Standard community-based intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Guttmann: lead
• University of Vic - Central University of Catalonia: collaborator

Study Sites (1)

Institut Guttmann Neurorehabilitation Hospital

Badalona, Barcelona, 08916, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 36206208 DERIVED

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• José A Merchán-Baeza

  University of Vic-UCC

  STUDY DIRECTOR

Central Study Contacts

Marco A Raya-Ruiz

CONTACT

+34934977700; maraya@guttmann.com

Beatriz Castaño-Monsalve

CONTACT

+34934977700; bcastano@guttmann.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: October 14, 2020
• Study Start: September 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)