Back to results

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

Primary Purpose

Acquired Brain Injury, Mental Health Issue

Status

Recruiting

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Community-based Occupational Therapy

Standard community-based intervention

About this trial

This is an interventional treatment trial for Acquired Brain Injury

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Institut Guttmann Neurorehabilitation HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Community-based Occupational Therapy

Standard community-based intervention

Arm 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.

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

Outcomes

Primary Outcome Measures

World Health Organization Quality of Life-BREF, spanish version (WHOQoL-BREF)

This scale provides a profile of quality of life perceived by the subject.

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.

Secondary Outcome Measures

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.

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.

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.

Role Checklist Version 3 (RCV3)

An occupational therapy measure that provides information about the participation and satisfaction with performance in desired and meaningful roles.

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.

Full Information

NCT ID

NCT04586842

First Posted

July 21, 2020

Last Updated

July 18, 2022

Sponsor

Institut Guttmann

Collaborators

University of Vic - Central University of Catalonia

1. Study Identification

Unique Protocol Identification Number

NCT04586842

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

September 2022 (Anticipated)

Study Completion Date

September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Guttmann

Collaborators

University of Vic - Central University of Catalonia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acquired Brain Injury, Mental Health Issue

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Community-based Occupational Therapy

Arm Type

Experimental

Arm 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.

Arm Title

Standard community-based intervention

Arm Type

Active Comparator

Arm 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).

Intervention Type

Behavioral

Intervention Name(s)

Community-based Occupational Therapy

Intervention Description

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

Intervention Name(s)

Standard community-based intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

World Health Organization Quality of Life-BREF, spanish version (WHOQoL-BREF)

Description

This scale provides a profile of quality of life perceived by the subject.

Time Frame

1 year

Title

Canadian Occupational Performance Measure, spanish version (COPM)

Description

This scale is an evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Community Integration Questionnaire, spanish version (CIQ)

Description

Provides the measure of an individual's level of integration into the home and community following traumatic brain injury.

Time Frame

1 year

Title

Activity Card Sort, spanish version (ACS)

Description

An Occupational Therapy scale that measures the level of participation perceived by the person through the use of photographs that reflect everyday activities.

Time Frame

1 year

Title

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

Description

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.

Time Frame

1 year

Title

Role Checklist Version 3 (RCV3)

Description

An occupational therapy measure that provides information about the participation and satisfaction with performance in desired and meaningful roles.

Time Frame

1 year

Title

Functional Independence Measure (FIM)

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marco A Raya-Ruiz

Phone

+34934977700

Ext

2273

maraya@guttmann.com

First Name & Middle Initial & Last Name or Official Title & Degree

Beatriz Castaño-Monsalve

Phone

+34934977700

Ext

3225

bcastano@guttmann.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

José A Merchán-Baeza

Organizational Affiliation

University of Vic-UCC

Official's Role

Study Director

Facility Information:

Facility Name

Institut Guttmann Neurorehabilitation Hospital

City

Badalona

State/Province

Barcelona

ZIP/Postal Code

08916

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Beatriz Castaño-Monsalve

Phone

+34934977700

Ext

3225

bcastano@guttmann.com

First Name & Middle Initial & Last Name & Degree

Marco A Raya-Ruiz

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36206208

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs