NCT04586842

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

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)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (estimated)
• Sponsor: Institut Guttmann · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	Standard community-based intervention	Interventions received at the community, public or private level (e.g. community nursing, social education and/or psychology).

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2020-10-14
• Last updated: 2022-07-19

Locations

1 site across 1 country: Spain