Status
Conditions
Treatments
Study type
Funder types
Identifiers
About
Background:People in compulsory forensic psychiatric care experience high rates of metabolic syndrome, cardiovascular disease, and related lifestyle risk factors, yet structured preventive health interventions are uncommon in secure psychiatric settings. The Structured Health Dialogue (SHD), a Swedish primary care model for cardiovascular disease prevention, combines motivational interviewing with individualised risk assessment and tailored lifestyle advice.
Objective:To evaluate the feasibility, acceptability, and preliminary effects of an adapted SHD intervention in forensic psychiatric inpatient care.
Methods:This single-centre, parallel-group, randomized controlled feasibility trial will recruit 50 adults aged 18-64 years from a secure forensic psychiatric clinic in Sweden. Participants will be randomized (1:1) to SHD plus usual care or usual care alone. The SHD includes health screening, lifestyle assessment, personalised cardiovascular risk feedback, and tailored recommendations. Primary outcomes are recruitment, retention, dropout, and assessment completion rates. Secondary outcomes include changes in metabolic risk factors and patient-reported quality of life and functioning (EQ-5D-5L, Mental Fatigue Scale) from baseline to 12 months.
Conclusion: This study will inform the feasibility and potential effectiveness of implementing structured, person-centred preventive health interventions in forensic psychiatric care, guiding the design of a future full-scale trial.
Full description
Individuals receiving compulsory forensic psychiatric care typically present with severe mental disorders such as schizophrenia, schizoaffective disorder, or personality disorders, and are legally detained following offenses committed under the influence of psychiatric illness. This patient population has a markedly reduced life expectancy-by up to 15-20 years-primarily due to preventable somatic conditions such as cardiovascular disease, type 2 diabetes, and other metabolic disorders. Contributing factors include sedentary lifestyle, unhealthy dietary patterns, tobacco and alcohol use, limited health literacy, and the metabolic side effects of long-term antipsychotic treatment. The restrictive environment of secure psychiatric care may further limit opportunities for physical activity and healthy eating. Epidemiological studies consistently show that obesity, metabolic syndrome, and cardiometabolic risk factors are highly prevalent among forensic psychiatric inpatients, with rates often exceeding those observed in both the general population and other psychiatric settings. Despite this, structured preventive health interventions are rarely implemented in forensic psychiatry, and evidence on how such programs can be adapted to this context remains limited.
The Structured Health Dialogue (SHD) is a validated Swedish primary care method for cardiovascular disease prevention. It integrates evidence-based behavioural strategies such as motivational interviewing with an individualized risk assessment. Central to the method is a visual tool, the so-called "health curve," which is generated from systematically collected data including biometric measurements, laboratory tests, and a structured lifestyle questionnaire. This visual risk profile provides a concrete and accessible summary of the individual's cardiometabolic risk factors, which is then used as the foundation for the health dialogue. By combining objective data with motivational interviewing, SHD facilitates patient engagement, enhances understanding of risk, and supports goal-setting for behavioural change. Evidence from primary care indicates that SHD improves lifestyle habits, metabolic health indicators, and patient participation in preventive care. However, its feasibility and potential effectiveness in compulsory forensic psychiatric care have not yet been evaluated in a randomized controlled setting.
This study is designed as a single-centre, parallel-group randomized controlled feasibility trial conducted at the Regional Forensic Psychiatric Clinic in Växjö, Sweden. The trial follows methodological guidance for feasibility and pilot studies and will be reported according to the CONSORT 2010 extension for pilot and feasibility trials. Eligible participants will be randomized in a 1:1 ratio to either the intervention group (SHD plus usual care) or the control group (usual care only). Randomization will be stratified by ward type and implemented using a computer-generated sequence with block randomization within security classes I-III. Block randomization is applied to ensure balance between groups, as patients in class I wards are often in an earlier phase of treatment or present with more severe psychiatric symptoms compared to patients in classes II and III. From a methodological perspective, stratification and block randomization by security class reduces the risk of systematic imbalance in baseline characteristics, thereby controlling for potential confounding related to ward type and severity of illness.
The intervention consists of two nurse-led SHD sessions delivered over a 12-month period. Each session lasts approximately 60-90 minutes and includes systematic health screening (anthropometric and biometric measures, fasting blood tests), a structured lifestyle questionnaire, and individualized risk feedback using the health curve. The sessions employ motivational interviewing techniques to support patient autonomy, set realistic lifestyle goals, and identify strategies for behavioural change. Tailored recommendations and referrals to relevant health services are provided when needed.
Assessments are scheduled at baseline, 6 months, and 12 months, including biometric measurements and validated self-report questionnaires on lifestyle behaviours, quality of life, and functioning. Feasibility outcomes include recruitment rates, retention, adherence to intervention and follow-up, and completeness of data collection. Secondary outcomes will provide preliminary estimates of intervention effects on metabolic risk factors, lifestyle habits, and self-reported quality of life, which will inform the design of a future adequately powered randomized controlled trial.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
50 participants in 2 patient groups
Loading...
Central trial contact
Mikael Vestlund Wibom, MD, Specialist general medicin; Märta Wallinius, Associate proffessor
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal