Community-based Mental Health Care for People With Severe and Enduring Mental III Health (RECOVER-E)

The National Center for Public Health and Analyzes, Bulgaria

Status: Unknown

Conditions: Schizophrenia; Bipolar Disorder; Severe Depression

Treatments: Other: Community mental health team

Study type: Interventional

Funder types: Other

Identifiers

NCT03922425

01052019

Details and patient eligibility

About

A single-blinded hybrid effectiveness-implementation trial (Type II), that both evaluates the intervention outcomes (clinical and service use outcomes) through patient-randomization in the implementation sites, as well as evaluates the implementation strategy chosen for the intervention and its impact on implementation outcomes (e.g. adoption, fidelity, acceptability and maintenance (continued implementation) of the intervention).

Full description

The overall goal of the study is to contribute to improving the level of functioning and quality of life and mental health outcomes for people with severe and enduring mental ill health (SMI) (schizophrenia, bipolar disorder, depression) by adapting and upscaling the implementation of a community-based service delivery model in Montenegro. Effectiveness component of the trial: Multidisciplinary community mental health teams for people with SMI. The intervention condition offers flexible, assertive community treatment (FACT) in the community for people with SMI. FACT can intensify (e.g. provide more intensive treatment in the form of daily home visits, crisis care at home, more intensive evidence-based psycho-social and pharmacological treatments) or provide less intensive treatment depending on client need. It can also provide less intensive care during non-crisis periods, offering routine home treatment where a combination of psychological and pharmacological treatments (e.g. cognitive behavioral therapy, motivational interviewing, family-based interventions) are offered, as well as care processes (reviewing recovery and crisis/treatment plans, and the clients' Wellness Recovery Action Plan), and social care interventions (assistance in obtaining or maintaining employment, looking for reasonable accommodation options). Care offered in this project in the intervention condition will be provided by a multidisciplinary community mental health team (CMHT), consisting of a diverse set of professionals including psychiatrists, psychologists, nurses, and social workers, that deliver integrated medical and social care that are focused on (symptomatic-, functional- and personal-) recovery. CMHTs will provide home-based treatment inclusive of crisis resolution services and procedures for early recognition of sub-clinical psychosis and bipolar disorder, ACT, and intensive case management. Integrated care (i.e. health and social care interventions) will be provided to all clients. Furthermore, health and social care evidence-based interventions for severe mental illnesses will be employed during home treatment, such as family-based interventions, motivational interviewing, and cognitive behavioral therapies, combined with medication management and identifying employment (paid and unpaid options) and support in finding and maintaining this employment, (Wellness Recovery Action Plan (WRAP) recovery groups and housing opportunities. Comparison condition: Usual care Health care settings and their providers randomized to the control condition receive usual care.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-65
• Current service users, with severe and enduring mental disorder,
• Severe Mental Illnesses - bipolar disorder, severe depression, or schizophrenia

Exclusion criteria

• Patients who do not consent to their data being collected
• Patients with acute somatic disorders
• Patients who are under the age of 18 at the start of the study.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

Community mental health team (CMHT)

Experimental group

Description:

CMHTs will be multidisciplinary; that is, staff will be appointed to the CMHTs that include nurses, social workers, psychiatrists, psychologists, and in this project, a peer expert (a person with lived experience of mental health services). All staff within the CMHT will have defined roles and responsibilities that align with the staff functions, roles and linkages detailed in evidence-based service delivery models for community mental health teams. Participant will randomly be assigned to CMHT that will provide outreach mental health care during the project.

Treatment:

Other: Community mental health team

Standard care

No Intervention group