Study protocol for a non-randomised controlled trial: Community-based occupational therapy intervention on mental health for people with acquired brain injury (COT-MHABI)

Abstract

Introduction: The sequelae of moderate-severe acquired brain injury (ABI) encompass motor, cognitive, sensory, emotional and behavioural areas that affect meaningful occupational participation and quality of life, with a high prevalence of associated mental disorders. When the patient returns to community life after discharge from the hospital, specialised care is generally insufficient due to the lack of consideration of the dual condition of mental disorder and ABI. Since there is a negative impact on competence and thus on occupational participation, occupational therapy represents a convenient way of intervention. On these assumptions, a community-based occupational therapy protocol on mental health for people with moderate/severe acquired brain injury (COT-MHABI) is presented. It is focused on meaningful occupational participation and looks for improvement in the quality of life.

Methods and analysis: This study aims: (i) to design a protocol to evaluate the effectiveness of a community occupational therapy intervention based on MOHO for patients with a dual (mental health/ABI) for improving quality of life and self-perceived occupational performance; (ii) to analyse the outcomes of occupational and social variables (occupational balance, participation level, satisfaction with occupation and performed roles and community integration) after the COT-MHABI process; (iii) to analyse the impact of quality of life on satisfaction with occupations performed by this population. A non-randomised controlled clinical trial will be performed. Patients assigned to the experimental group will receive over one year of on-site and telematic occupational therapy sessions, 16 sessions on average. Variables such as quality of life, community integration or satisfaction with occupational performance will be collected at baseline, 6, and 12 months.

Discussion: The needs for the dual mental/ABI population in their reintegration into the community are related to the associated deficits and to the absence of specialised services for the complexity of this patient profile. Few studies consider the coexistence of mental health and ABI issues. The COT-MHABI protocol is proposed to provide continuity to the community needs of this population, conceptualised from occupational participation, person-centred and focused on meaningful activities.

Clinical trial registration: Trial identifier and registry name ClinicalTrials.gov ID: NCT04586842 https://ichgcp.net/clinical-trials-registry/NCT04586842?term=252136&draw=2&rank=1; Pre-results; Community-based Occupational Therapy Intervention on Mental Health for People With Acquired Brain Injury (COT-MHABI).

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1. SPIRIT 2013 schedule.

SPIRIT schedule of enrollment, interventions and assessments timepoints along the study period (1 year maximum after the allocation).

Fig 2. Study methods flow chart.

134 participants will be assessed for elegibility, allocating 67 in each arm (experimental and control groups). COT-MHABI protocol will be applied in experimental group and regular health care interventions in control group. For both groups, outcomes will be assessed over a one-year period at baseline, by the 6th and 12th month, when data collection is closed and analysis begins.

Fig 3. Outline of the COT-MHABI intervention process.

The intervention will begin with an initial comprehensive assessment during the first session. The goals are agreed with the participant in the following sessions based on a specific assessment. Subsequently, between the 4th and the 16th session (on-site and telematics), the intervention will be implemented according to the goals and through the three-level process (Exploration, Competence and Achievement) based on the Model of Human Occupation.