Improving heart and metabolic health in people with severe mental illness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial focuses on enhancing cardiometabolic health in individuals with psychotic disorders, who often face significant health challenges. The study will involve 644 adults diagnosed with schizophrenia spectrum disorders, recruited from six outpatient clinics in Gothenburg. Participants will receive a comprehensive intervention program designed to promote healthy lifestyles and improve quality of life. The approach leverages the regular visits to outpatient clinics and the expertise of diverse health professionals to deliver individualized care.

Why it matters

Who can join: the full rules

Inclusion criteria

1. Adults ≥18 years of age meeting the International Classification of Diseases, Tenth Revision (ICD-10) diagnostic criteria for any one of the schizophrenia spectrum disorders (F20-F25 or F28-F29)
2. Ability to provide informed consent

Exclusion criteria

1. Having an electrical medical implant such as a pacemaker or other mechanical implants
2. Pregnancy
3. Deemed unsuitable by the investigator: A person may be deemed unsuitable for participation if circumstances prevent safe or reliable participation in the trial. Examples include inability or unwillingness to maintain contact with the clinic (e.g., absence of a stable address or telephone number), planned relocation or transfer to another treatment facility, municipality, or country during the trial period, mobility limitations or other practical barriers preventing attendance at clinic visits, or administrative restrictions preventing appropriate documentation in medical records or trial databases (e.g., protected or anonymous identity status). Such decisions are made on an individual basis in consultation with the clinical team (case manager (CM), treating psychiatrist, and site principal investigator (PI)) to ensure patient safety and trial integrity.
4. Prior participation in the LAGOM trial during a previous inclusion cycle (i.e., participants can only be included once during the trial period).
5. Currently under compulsory care.

Where it's running

• Psykosmottagning Centrum
  Gothenburg, Sweden Recruiting
• Psykosmottagning Nordost
  Gothenburg, Sweden Recruiting
• Psykosmottagning Öster
  Gothenburg, Sweden Recruiting
• Psykosmottagning Hisingen
  Gothenburg, Sweden Recruiting
• Psykosmottagning Väster
  Gothenburg, Sweden Recruiting
• Psykosmottagning Mölndal
  Mölndal, Sweden Recruiting

Study contacts

• Study coordinator: Hemen Najar, M.D., Ph.D.
• Email: hemen.najar@vgregion.se
• Phone: 0046 73 566 15 64

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations

  This study tests whether theta-burst transcranial magnetic stimulation can lessen persistent auditory verbal hallucinations in adults with schizophrenia-spectrum or psychotic disorders who have not responded to antipsychotic meds.

  Recruiting Ciusss de L'Est de l'Île de Montréal · Montreal, Quebec · NCT07902518

• Small Soteria-inspired unit vs. standard closed ward for acute psychosis

  A randomized or semi-randomized comparison tests whether a small Soteria-style inpatient unit improves outcomes for adults with acute psychosis compared to a conventional closed psychiatric ward.

  Recruiting Jerusalem Mental Health Center · Jerusalem, Jerusalem · NCT07836348

• Accelerated Brain Stimulation for Young People at Risk of Psychosis

  This study tests a five-day accelerated brain-stimulation treatment to see if it is safe and tolerable for young people at risk for psychosis and to explore biomarkers that might show whether it works.

  Recruiting Douglas Mental Health University Institute · Verdun, Quebec · NCT07786714

• Racial differences in how people experience paranoia

  This project will see if brief race-related stressful experiences increase feelings of paranoia in Black American adults who take online surveys.

  Recruiting Indiana University · Bloomington, Indiana · NCT07460453

• Yoga-based group program plus usual care for outpatients with schizophrenia spectrum disorders

  This project will see if a 12-week yoga-based group program added to usual outpatient care helps adults with schizophrenia spectrum disorders reduce stress and symptom-related distress compared with exercise or usual care alone.

  Recruiting Charite University, Berlin, Germany · Berlin · NCT07455929

• Trying the Kiso Mind smartphone app for people with schizophrenia spectrum disorders

  This study tests whether the Kiso Mind smartphone app is acceptable, practical, and helpful for adults with schizophrenia or schizoaffective disorder alongside their usual care.

  Recruiting Charite University, Berlin, Germany · Berlin, State of Berlin · NCT07395206

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.