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

NCT ID: NCT04586842

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-09-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Community-based Occupational Therapy

Intervention Type: BEHAVIORAL

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

Control group of the study that will receive community-based interventions, public or private level (e.g. community nursing, social education and/or psychology).

Group Type: ACTIVE_COMPARATOR

Standard community-based intervention

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

Standard community-based intervention

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vic - Central University of Catalonia

OTHER

Sponsor Role: collaborator

Institut Guttmann

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José A Merchán-Baeza

Role: STUDY_DIRECTOR

University of Vic-UCC

Locations

Institut Guttmann Neurorehabilitation Hospital

Badalona, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Marco A Raya-Ruiz

Role: CONTACT

maraya@guttmann.com

+34934977700 ext. 2273

Beatriz Castaño-Monsalve

Role: CONTACT

bcastano@guttmann.com

+34934977700 ext. 3225

Facility Contacts

Beatriz Castaño-Monsalve

Role: primary

bcastano@guttmann.com

+34934977700 ext. 3225

References

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.

Reference Type: DERIVED

PMID: 36206208 (View on PubMed)

Other Identifiers

252136

Identifier Type: -

Identifier Source: org_study_id