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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03922425
Other study ID # 01052019
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date June 1, 2022

Study information

Verified date March 2021
Source The National Center for Public Health and Analyzes, Bulgaria
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 180
Est. completion date June 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Community mental health team
CMHT will provide home-based treatment inclusive of crisis resolution services and procedures for early recognition of subclinical psychosis and bipolar disorder, 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 illness (SMI) will be employed during home treatment, such as family-based interventions, motivational interviewing, and cognitive behavioural therapies, combined with medication management and identifying employment (paid and non paid options) and support in finding and maintaining this employment, recovery groups and housing opportunities.

Locations

Country Name City State
Bulgaria Mental Health Center "Nikola Shipkovenky" Sofia

Sponsors (2)

Lead Sponsor Collaborator
The National Center for Public Health and Analyzes, Bulgaria STICHTING TRIMBOS INSTITUT, NETHERLANDS

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in daily functioning World Health Organisation Disability Assessment Schedule 2 (WHODAS2) measures health and disability-level of functioning in 6 domains:Cognition, Mobility, Self-care,Getting along, Life activities, Participation in community activities.The instrument is self-reporting; can be administered by a health worker if needed. Answers are distributed into 5 categories:"none","mild","moderate","severe"and"extreme or cannot do". It ends with 3 items where answers are presented as number of days (when difficulties were present). Score on any dimension ranges 0 to 7, results are depicted in a diagram which reflects relation between dimensions(the higher the score, the lower level of difficulties/better functioning) and changes over time Baseline, 12 months and 18 months
Secondary Change in health-related quality of life Euro Quality of Life Index (Euro QoL 5-D 3-L). The instrument measures five dimensions: Mobility, Self-care, Daily activities, Pain/Discomfort and Anxiety/ Depression. Each dimension can be rated at three levels: from no problems to major problems. The five dimensions can be summed into a descriptive health state with 11111 representing no problems in any of the five health dimensions and 33333 indicating major problems in any of the five health dimensions. Second part of the instrument is the Visual Analogue Scale to assess health status at baseline, where 0 signifies worst imaginable health state, and 100 signifies best imaginable health state. Baseline, 12 months and 18 months
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