Severe Mental DisorderNCT03892473
Community-based Mental Health Care for People With Severe and Enduring Mental III Health ( RECOVER-E )
A study testing Community mental health teams (CMHT) and Care as usual (CAU) in people with Severe Mental Disorder and Schizophrenia, run by University of Skopje at 1 site in North Macedonia.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Mental Disorder, Schizophrenia, Bipolar Disorder
- What is being tested?
- Community mental health teams (CMHT) and Care as usual (CAU)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteNorth Macedonia
- Study dates
- 1 Jan 2018to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Exclusion criteria at the patient level includes patients who do not consent to their data being collected who are part of the intervention or control conditions, those who are under the age of 18 at the start of the study.
Trial locations and contacts
1 site in 1 country.
North Macedonia1 site
University clinic of psychiatry Skopje
Skopje, 1000
About this study
Official title: Large-scale Implementation of Community-based Mental Health Care for People With Severe and Enduring Mental III Health in Europe
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).
Read the detailed 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.
- Being tested
- Community mental health teams (CMHT), Care as usual (CAU)
- Keywords
- Community mental health teams
- Medical subject headings
- Mental Disorders, Schizophrenia, Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community mental health teams (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.
Care as usual (CAU)Other
Care as usual (CAU) usually consisting of inpatient psychiatric care or outpatient care prescribing medication.
| Study group | Role | What they receive |
|---|---|---|
| Flexible Assertive Community Treatment (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. Receives: Other: Community mental health teams (CMHT) |
| Care as usual (CAU) | Active comparator | Active Comparator: CAU (Care as usual) Patients with SMI receiving usual care, meaning mostly medical treatment Receives: Other: Care as usual (CAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: : Baseline, 12 months and 18 months
Secondary outcomes (1)
Change in health-related quality of life
Euro Quality of Life Index (Euro QoL 5-D 3-L). The instrument measures five dimensions:Dimension 1: Mobility; Dimension 2: Self-care;Dimension 3:Daily activities; Dimension 4: pain/discomfort; Dimension 5: 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.
Measured: Baseline, 12 months and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Jan 2018
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Severe Mental DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are 2 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.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Skopje
- Sponsor type
- University, hospital or other
- Collaborators
- Stichting Trimbos-Instituut
- Responsible party
- Principal investigator, Stojan Bajraktarov, University of Skopje
- Investigators
- Stojan Bajraktarov, PHD, Principal investigator, University Clinic of psychiatry Skopje
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892473
- Sponsor's protocol ID
- 779362
- Other IDs
- 779362RECOVER-E H2020
- Status last verified
- Mar 2019
- First submitted
- 26 Mar 2019
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared with the coordinating institute and Heidelberg University Hospital, the two institutions that will be in charge of analyzing data from all participating project sites.
Publications
Wijnen B, Smit F, Uhernik AI, Zegrec A, Dedovic J, Dinolova R, Nica R, Tomcuk A, Velickovski R, Wensing M, Shields-Zeeman L, Petrea I. Cost-effectiveness of community versus hospital-based mental healthcare for severe mental illness in South-East Europe: economic evaluation of five randomised trials. Eur J Health Econ. 2026 Jul 3. doi: 10.1007/s10198-026-01960-1. Online ahead of print.
PubMed 42393474Shields-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.
PubMed 41130742Roth 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.
PubMed 34689733Wijnen 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.
PubMed 32476658Shields-Zeeman L, Petrea I, Smit F, Walters BH, Dedovic J, Kuzman MR, Nakov V, Nica R, Novotni A, Roth C, Tomcuk A, Wijnen BFM, Wensing M. Towards community-based and recovery-oriented care for severe mental disorders in Southern and Eastern Europe: aims and design of a multi-country implementation and evaluation study (RECOVER-E). Int J Ment Health Syst. 2020 Apr 22;14:30. doi: 10.1186/s13033-020-00361-y. eCollection 2020.
PubMed 32336984
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Large-scale Implementation of Community-based Mental Health Care for People With Severe and Enduring Mental III Health in Europe
- ClinicalTrials.gov ID
- NCT03892473
- Acronym / sponsor ID
- 779362
- Keywords
- Community mental health teams
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of SkopjeUniversity, hospital or other
- Collaborators
- Stichting Trimbos-Instituut
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 27 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are 2 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.
| Arm | Type | Receives |
|---|---|---|
| Flexible Assertive Community Treatment (FACT) | Experimental | Other: Community mental health teams (CMHT)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. |
| Care as usual (CAU) | Active comparator | Other: Care as usual (CAU)Active Comparator: CAU (Care as usual) Patients with SMI receiving usual care, meaning mostly medical treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (1 listed)
- Exclusion criteria at the patient level includes patients who do not consent to their data being collected who are part of the intervention or control conditions, those who are under the age of 18 at the start of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community mental health teams (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. | Other | Flexible Assertive Community Treatment (FACT) |
| Care as usual (CAU)Care as usual (CAU) usually consisting of inpatient psychiatric care or outpatient care prescribing medication. | Other | Care as usual (CAU) |
Primary outcome
Changes in daily functioning
Time frame: : Baseline, 12 months and 18 months
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.
1 secondary outcome
Change in health-related quality of life
Time frame: Baseline, 12 months and 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Derived from this study: PubMed 42393474Wijnen B, Smit F, Uhernik AI, Zegrec A, Dedovic J, Dinolova R, Nica R, Tomcuk A, Velickovski R, Wensing M, Shields-Zeeman L, Petrea I. Cost-effectiveness of community versus hospital-based mental healthcare for severe mental illness in South-East Europe: economic evaluation of five randomised trials. Eur J Health Econ. 2026 Jul 3. doi: 10.1007/s10198-026-01960-1. Online ahead of print.
- Derived from this study: PubMed 41130742Shields-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.
- Derived from this study: PubMed 34689733Roth 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.
- Derived from this study: PubMed 32476658Wijnen 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.
- Derived from this study: PubMed 32336984Shields-Zeeman L, Petrea I, Smit F, Walters BH, Dedovic J, Kuzman MR, Nakov V, Nica R, Novotni A, Roth C, Tomcuk A, Wijnen BFM, Wensing M. Towards community-based and recovery-oriented care for severe mental disorders in Southern and Eastern Europe: aims and design of a multi-country implementation and evaluation study (RECOVER-E). Int J Ment Health Syst. 2020 Apr 22;14:30. doi: 10.1186/s13033-020-00361-y. eCollection 2020.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared with the coordinating institute and Heidelberg University Hospital, the two institutions that will be in charge of analyzing data from all participating project sites.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stojan Bajraktarov, PHD principal investigator
University Clinic of psychiatry Skopje
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community mental health teams (CMHT) and Care as usual (CAU) in people with Severe Mental Disorder and Schizophrenia, run by University of Skopje at 1 site in North Macedonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in North Macedonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in daily functioning (time frame: : Baseline, 12 months and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03892473, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2019.