Community-based Mental Health Care for People With Severe and Enduring Mental Ill Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2022-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness of Cognitive Behavioral Therapy for Treating Depression in People With Bipolar I Disorder

NCT00595387

Bipolar Disorder Depression

COMPLETED NA

Cognitive Behaviour Therapy and Cognitive Training in Work Rehabilitation for Persons With Severe Mental Illness

NCT01139502

Mental Illness

COMPLETED NA

Implementation and Evaluation of "Mindfulness-Based Cognitive Therapy" in a Health Care Region in Flanders: a Randomized Clinical Trial

NCT00259506

Recurrent Depression

COMPLETED NA

ImpleMentAll - Towards Evidence-based Tailored Implementation Strategies for eHealth

NCT03652883

Tailored Implementation: Online ItFits-toolkit Implementation as Usual

COMPLETED NA

"Art Therapy" in Acute Psychiatry

NCT03575442

Schizophrenia Mood Disorders Mental Disorder +1 more

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Severe Mental Disorders Schizophrenia Bipolar Disorder Severe Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

There are two study arms- groups - both consisting of patients with SMI (severe mental illness). One group will be receiving care as usual, which in the actual setting means mostly medical treatment, without home care and assertive treatment through community based outreach teams. Another, intervention group, will be receiving assertive treatment care, with mobile assertive teams, consisting of at least three team members.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FACT

Patients with SMI, receiving evidence-based interventions by the community mental health teams (CMHTs), inspired by the Flexible Assertive Community Treatment (FACT) service delivery model.

Group Type EXPERIMENTAL

CMHT

Intervention Type OTHER

Community mental health teams (CMHTs) delivering evidence-based interventions to people with SMI, inspired by the Flexible Assertive Community Treatment (FACT) service delivery model.

CAU (Care as usual)

Patients with SMI receiving usual care, meaning mostly medical treatment

Group Type ACTIVE_COMPARATOR

CAU

Intervention Type OTHER

Care as usual (CAU) usually consisting of inpatient psychiatric care or outpatient care prescribing medication.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CMHT

Community mental health teams (CMHTs) delivering evidence-based interventions to people with SMI, inspired by the Flexible Assertive Community Treatment (FACT) service delivery model.

Intervention Type OTHER

CAU

Care as usual (CAU) usually consisting of inpatient psychiatric care or outpatient care prescribing medication.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults (ages 18-65), current service users, with severe and enduring mental ill-health, which, for clinical purposes, typically relates to diagnostic categories of bipolar disorder, severe depression, or schizophrenia. We use the following definition for SMI:

* Presence of a psychiatric disorder that requires care and treatment (so, they are NOT in symptom remission)
* Has severe limitations in social and community functioning (i.e. they are not in functional remission)
* These problems are not transient (e.g. temporary, one-off) in nature (They are systematic and long-term)
* Coordinated care provided by care networks or teams is needed to implement the treatment plan

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No