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

Guttmann Institute

Status: Enrolling

Conditions: Mental Health Issue; Acquired Brain Injury

Treatments: Behavioral: Community-based Occupational Therapy; Behavioral: Standard community-based intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04586842

252136

Details and patient eligibility

About

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.

Enrollment: 134 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

Community-based Occupational Therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Community-based Occupational Therapy

Standard community-based intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard community-based intervention