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

Not Applicable

• Conditions: Mental Health Issue; Acquired Brain Injury

• Registration Number: NCT04586842
• Lead Sponsor: Institut Guttmann

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-21
• Study Start: 2020-09-01
• Study First Submitted QC: 2020-10-09
• Study First Posted: 2020-10-14
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-19
• Primary Completion: 2022-09
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Canadian Occupational Performance Measure, spanish version (COPM)	1 year	This scale is an evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time.
World Health Organization Quality of Life-BREF, spanish version (WHOQoL-BREF)	1 year	This scale provides a profile of quality of life perceived by the subject.

Secondary Outcome Measures

Name	Time	Method
Community Integration Questionnaire, spanish version (CIQ)	1 year	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)	1 year	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)	1 year	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)	1 year	An occupational therapy measure that provides information about the participation and satisfaction with performance in desired and meaningful roles.
Functional Independence Measure (FIM)	1 year	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.

Trial Locations

Locations (1)

Institut Guttmann Neurorehabilitation Hospital; 🇪🇸 Badalona, Barcelona, Spain