Меню
Набор по приглашению NCT07157813

Improving Lifestyle Habits and Metabolic Health in Forensic Psychiatric Patients

Без фазы С лечением Forensic Psychiatric Patients Cardio Vascular Disease Health Promotion Forensic Mental Health

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Structured Health Dialogue.
Кому может быть актуально
Состояния в реестре: Forensic Psychiatric Patients, Cardio Vascular Disease, Health Promotion, Forensic Mental Health. Базовые параметры: 18 лет — 64 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швеция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Structured Health Dialogue
    In addition to usual care, participants take part in two nurse-led Structured Health Dialogue (SHD) sessions at baseline and 12 months. The results from the measurements and questionnaires are integrated into an individualized visual risk profile ("health curve"). This profile is used as the foundation for a 60-90 minute dialogue, guided by motivational interviewing principles, to enhance risk awareness, promote self-reflection, and support participants in setting achievable goals for lifestyle

Первичные конечные точки

  • Feasibility of the study design and Targeted health dialogue [Срок оценки: 24-month]
  • Feasibility of the study design and Targeted health dialogue [Срок оценки: 24-month]
Вторичные конечные точки (12)
  • Biometric measures, Body Mass Index (BMI) [Срок оценки: 12 months]
  • Biometric measures, Waist-to-Hip Ratio [Срок оценки: 12 months]
  • Biometric measures, Blood Pressure [Срок оценки: 12 months]
  • Biometric measures, Fasting Plasma Glucose [Срок оценки: 12 months]
  • Biometric measures, Blood Lipid Status [Срок оценки: 12 months]
  • Biometric measurments, Body Weight [Срок оценки: 12 months]
  • Biometric measures, Body Length (Height) [Срок оценки: 12 months]
  • Lifestyle Habits - Physical Activity [Срок оценки: 12 months]
  • Lifestyle Habits - Diet [Срок оценки: 12 months]
  • Lifestyle Habits - Tobacco Use [Срок оценки: 12 months]
  • Lifestyle Habits - Alcohol Consumption [Срок оценки: 12 months]
  • Mental Fatigue [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • Adults aged 18-64 years
  • Hospitalized at the forensic psychiatric clinic in Växjö, Sweden.

Критерии исключения

  • Severe language barriers.
  • Severe cognitive impairment
  • Acute psychiatric states (e.g., suicidality or acute psychosis)
  • Aggression hindering safe participation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Швеция · 1 центр
  • Regional Forensic Psychiatric Clinic, Växjö — Vaxjo

Публикации

  • Sivak L, Forsman J, Masterman T. Duration of forensic psychiatric care and subsequent criminal recidivism in individuals sentenced in Sweden between 2009 and 2019. Front Psychiatry. 2023 Mar 14;14:1129993. doi: 10.3389/fpsyt.2023.1129993. eCollection 2023. PMID 37009123
  • Voulgaris A, Kose N, Konrad N, Opitz-Welke A. Prison Suicide in Comparison to Suicide Events in Forensic Psychiatric Hospitals in Germany. Front Psychiatry. 2018 Aug 28;9:398. doi: 10.3389/fpsyt.2018.00398. eCollection 2018. PMID 30210374
  • Blomstedt Y, Norberg M, Stenlund H, Nystrom L, Lonnberg G, Boman K, Wall S, Weinehall L. Impact of a combined community and primary care prevention strategy on all-cause and cardiovascular mortality: a cohort analysis based on 1 million person-years of follow-up in Vasterbotten County, Sweden, during 1990-2006. BMJ Open. 2015 Dec 18;5(12):e009651. doi: 10.1136/bmjopen-2015-009651. PMID 26685034
  • Laporte N, Ozolins A, Westling S, Westrin A, Wallinius M. Clinical Characteristics and Self-Harm in Forensic Psychiatric Patients. Front Psychiatry. 2021 Aug 2;12:698372. doi: 10.3389/fpsyt.2021.698372. eCollection 2021. PMID 34408680
  • Bushe CJ, Taylor M, Haukka J. Mortality in schizophrenia: a measurable clinical endpoint. J Psychopharmacol. 2010 Nov;24(4 Suppl):17-25. doi: 10.1177/1359786810382468. PMID 20923917
  • Lingfors H, Persson LG. All-cause mortality among young men 24-26 years after a lifestyle health dialogue in a Swedish primary care setting: a longitudinal follow-up register study. BMJ Open. 2019 Jan 29;9(1):e022474. doi: 10.1136/bmjopen-2018-022474. PMID 30696668
  • Brown S, Kim M, Mitchell C, Inskip H. Twenty-five year mortality of a community cohort with schizophrenia. Br J Psychiatry. 2010 Feb;196(2):116-21. doi: 10.1192/bjp.bp.109.067512. PMID 20118455
  • Howner K, Andine P, Bertilsson G, Hultcrantz M, Lindstrom E, Mowafi F, Snellman A, Hofvander B. Mapping Systematic Reviews on Forensic Psychiatric Care: A Systematic Review Identifying Knowledge Gaps. Front Psychiatry. 2018 Sep 25;9:452. doi: 10.3389/fpsyt.2018.00452. eCollection 2018. PMID 30319459

Идентификаторы

NCT: NCT07157813 · FOR-HEALTH · 2025-02066-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗