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

NCT03837340 | Unknown DMC

• 5 other identifiers: 779362779362RECOVER-E H2020U1111-1226-8617SPH-3463/1PHI-01-8396
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Severe Mental Disorders; Schizophrenia; Bipolar Disorder; Severe Depression

Keywords

Community mental health teams

Outcome Measures

Primary Outcomes (1)

• Changes in daily functioning

  World Health Organisation Disability Assessment Schedule 2 (WHO-DAS2) measures health and disability-level of functioning in 6 domains:1.Cognition - understanding and communicating; 2.Mobility - moving and getting around; 3.Self-care - attending to one's hygiene,dressing, eating and staying alone; 4.Getting along - interacting with others; 5. Life activities - domestic responsibilities, leisure, work and school; 6.Participation in community activities,in society.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 Outcomes (1)

• Change in health-related quality of life

  Baseline, 12 months and 18 months

Study Arms (2)

FACT

EXPERIMENTAL

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.

Other: CMHT

CAU (Care as usual)

ACTIVE COMPARATOR

Patients with SMI receiving usual care, meaning mostly medical treatment

Other: CAU

Interventions

CMHT 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.

FACT

CAU OTHER

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

CAU (Care as usual)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Special Psychiatric Hospital Kotor: lead
• Stichting Trimbos-Instituut: collaborator

Study Sites (1)

ZU Specijalna bolnica za psihijatriju Dobrota Kotor

Kotor, 85330, Montenegro

Location

Related Publications (3)

• Shields-Zeeman L, Smit F, Wijnen B, Roth C, Wensing M, Petrea I; RECOVER-E consortium; Bolinski F, Bajraktarov S, Dedovic J, Keet R, Rojnic Kuzman M, Nakov V, Nica R, Novotni A, Tomcuk A, Djurisic T, Morales G, Rotaru Anghelescu T; RECOVER-E study. Community versus institutionalised care for people with severe mental illness in five countries in Southeast Europe: pooled analysis of five randomised trials. BMJ Glob Health. 2025 Oct 23;10(10):e018594. doi: 10.1136/bmjgh-2024-018594.

  PMID: 41130742 DERIVED

• Roth C, Wensing M, Kuzman MR, Bjedov S, Medved S, Istvanovic A, Grbic DS, Simetin IP, Tomcuk A, Dedovic J, Djurisic T, Nica RI, Rotaru T, Novotni A, Bajraktarov S, Milutinovic M, Nakov V, Zarkov Z, Dinolova R, Walters BH, Shields-Zeeman L, Petrea I. Experiences of healthcare staff providing community-based mental healthcare as a multidisciplinary community mental health team in Central and Eastern Europe findings from the RECOVER-E project: an observational intervention study. BMC Psychiatry. 2021 Oct 24;21(1):525. doi: 10.1186/s12888-021-03542-2.

  PMID: 34689733 DERIVED

• Wijnen BFM, Smit F, Uhernik AI, Istvanovic A, Dedovic J, Dinolova R, Nica R, Velickovski R, Wensing M, Petrea I, Shields-Zeeman L. Sustainability of Community-Based Specialized Mental Health Services in Five European Countries: Protocol for Five Randomized Controlled Trial-Based Health-Economic Evaluations Embedded in the RECOVER-E Program. JMIR Res Protoc. 2020 Jun 1;9(6):e17454. doi: 10.2196/17454.

  PMID: 32476658 DERIVED

MeSH Terms

Conditions

Mental Disorders; Schizophrenia; Bipolar Disorder; Depression

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Mood Disorders; Behavioral Symptoms; Behavior

Study Officials

• Aleksandar Tomcuk

  Special Psychiatric Hospital Kotor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 12, 2019
• Study Start: January 1, 2018
• Primary Completion: January 1, 2021
• Study Completion: June 1, 2022
• Last Updated: March 20, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: During the project - and for a period of five years after the end of the project - each beneficiary will disseminate its results by disclosing them to the public by appropriate means as soon as possible, including scientific publications in any medium.
• Access Criteria: In order to protect participant privacy, data will only be released if the request abides by national and European patient data laws and guidelines, by guidelines for use of mental health data, and by the guidelines set by each research site's ethical review board. Those requesting access to the data will be asked to verify their identity, provide information on how the data will be used, and provide information about their institutions. All requests and releases of data will be logged by the Data Protection Officer.All identifiable data will be kept confidential and will not be released. Data access will be limited to a need only basis. All research partners involved in RECOVER-E will have access to open data sets. As well, datasets will be made available to the European Commission or Global Alliance for Chronic Diseases on request. All de-identified data sets will be stored at the coordinating institute on password-protected, non-networked servers with limited access.

Locations

MO (1)