Bipolar Disorder, Metabolic Complication, Schizophrenia Spectrum and Other Psychotic Disorders, Severe Mental Disorder, Side-Effect;Medication
Conditions
Keywords
Severe mental illness, Overweight and obesity, Antipsychotic medication, Dysmetabolism, Schizophrenia Spectrum Disorders, Bipolar disorder
Brief summary
This study will examine the effectiveness of a Pragmatic, Metabolic Care Clinic for Patients With Severe Mental Illness
Detailed description
Severe mental illness (SMI), including schizophrenia spectrum disorders and bipolar disorder, is associated with high mortality rates and cardiovascular disease. Obesity and dysmetabolism caused by antipsychotic medication comprise modifiable risk factors, which remain undertreated. The investigators will address the gaps in cardiometabolic care of SMI patients by examining the effectiveness of a pragmatic metabolic care clinic for patients with SMI. Moreover, the investigators will include qualitative investigation of patients' perspectives in relation to acceptability, satisfaction with care, and motivation for health behaviour change. A total of 84 patients between 18-45 years with diagnoses of schizophrenia spectrum disorders or bipolar disorder will be recruited from inpatient and outpatient clinics in the Mental Health Services of the Capital Region of Denmark. Eligible patients are antipsychotics-treated and present with a 5% weight increase / 5 cm waistline increase since initiation of antipsychotic therapy or body mass index (BMI) ≥30 kg/m2 or BMI ≥27 kg/m2 and concomitant prediabetes, diabetes, hypertension, sleep apnoea and/or dyslipidaemia. Patients will be enrolled in an open-label randomized controlled parallel-group trial with an allocation-ratio of 1:1 to a pragmatic, specialized metabolic clinic with measurement-based care and evidence-based best-practice treatment or standard care. The primary outcome is the proportion of patients in the intervention group achieving a weight loss ≥5% of initial body weight vs the standard care group at 12 months. Secondary and exploratory outcomes include changes in other cardiovascular risk factors, quality of life, personal recovery and cognitive measures. Finally, qualitative interviews will explore patient experience and contextual factors.
Interventions
OTHERTreatment in the Meta Care Clinic
* Consultations by medical doctors with specific metabolic training from the metabolic clinic located at Centre for Addiction and Mental Health in Toronto, Canada, and an exercise physiologist. * Evaluation of their psychopharmacotherapy with consultation and detailed recommendations to the patients' treating psychiatrist and/or general practitioner regarding dosage reductions or switching of psychotropics if this is clinically feasible to reduce the metabolic burden. * Lifestyle interventions * Pharmacotherapy with evidence to support use to mitigate antipsychotic-induced weight gain * Treatment of other cardiovascular risk factors such as dyslipidaemia, hypertension, smoking and diabetes in close collaboration with recognized specialists in endocrinology. * Assessment of plans at conferences with participation of the sponsor, the primary investigator as well as recognized specialists in endocrinology and psychiatry. * Qualitative interviews will be conducted post-intervention.
OTHERStandard care with general practitioner and/or outpatient clinics
Following measurements after 12 months, patients will receive individualized lifestyle recommendations from an exercise physiologist and a MD will offer to send recommendations regarding the following potential post-trial interventions to the patients' general practitioner and/or outpatient clinic prepared in close collaboration with recognized specialists in psychiatry and endocrinology: * Suggestions regarding relevant psychotropic medication adjustments or switches if this is found relevant and clinically feasible to reduce the metabolic burden. * Suggestions regarding potential add-on of weight reducing pharmacotherapy. * Suggestions regarding pharmacological treatment of other cardiovascular risk factors such as dyslipidaemia, hypertension, smoking and type 2 diabetes.
Sponsors
Mental Health Centre Glostrup
University of Toronto
Herlev and Gentofte Hospital
Bjorn H. Ebdrup
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pragmatic, open label, non-blinded randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Patients with schizophrenia spectrum disorders (International classification of diseases; ICD-10: DF2x) or bipolar disorder (ICD-10: DF30.x or DF31.x) * Medical treatment with antipsychotics * Age 18-45 years * Legally competent * Able to give informed consent and either: \- Body mass index (BMI) ≥30 kg/m2. Or * BMI ≥27 kg/m2 and at least one of the following: * Hypertension defined as treatment with ≥1 antihypertensive drug or out-of-office / 24-hour, non-invasive ambulatory blood pressure ≥140/90 mmHg within the previous 6 months * Dyslipidaemia defined as treatment with ≥1 lipid-lowering drug or elevated low-density lipoprotein (LDL) cholesterol (≥3.0 mmol/l), elevated triglycerides (≥1.7 mmol/l) or low high-density lipoprotein cholesterol (≥1.2 mmol/l in women and ≥1.0 mmol/l in men) within the previous 6 months * Sleep apnoea (ICD-10 DG473). * Prediabetes or diabetes defined as HbA1c ≥42 mmol/mol or impaired fasting glucose as defined by the International Diabetes Federation within the previous 6 months. Or \- a history of rapid weight gain during antipsychotic therapy defined as increases of either ≥5% body weight or ≥5 cm waist circumference since initiation of antipsychotic therapy.
Exclusion criteria
* Clinical or laboratory evidence of comorbid medical disease not compatible with participation as judged by the research team. * Unstable psychiatric disorder as judged by the research team. * Severe current drug or alcohol misuse as judged by the research team. * Acute suicidal risk.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients achieving a weight loss of ≥5% of initial body weight. | 12 months | Proportion of patients in the intervention group achieving a weight loss of ≥5% of initial body weight vs the standard care group at 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients achieving a ≥50% reduction of low-density lipoprotein cholesterol | 12 months | Proportion of patients in the intervention group achieving a ≥50% reduction of initial low-density lipoprotein cholesterol vs the standard care group at 12 months. |
| Waist circumference | 12 months | Absolute and relative changes in waist circumference. Effect measurements: differences in mean changes between groups at 12 months. |
| Body mass index | 12 months | Changes in body mass index (BMI) where weight and height will be combined to report BMI in kg/m\^2. Effect measurements: differences in mean changes between groups at 12 months. |
| Glucose | 12 months | Fasting plasma glucose. Effect measurements: differences in mean changes between groups at 12 months. |
| Insulin | 12 months | Fasting Plasma insulin. Effect measurements: differences in mean changes between groups at 12 months. |
| The homeostatic Model Assessment for Insulin Resistance | 12 months | The homeostatic Model Assessment for Insulin Resistance (HOMA-IR) measured using fasting plasma glucose and fasting plasma insulin. Effect measurements: differences in mean changes between groups at 12 months. |
| Total cholesterol | 12 months | Fasting plasma total cholesterol. Effect measurements: differences in mean changes between groups at 12 months. |
| Low-density lipoprotein cholesterol | 12 months | Fasting plasma Low-density lipoprotein (LDL) cholesterol. Effect measurements: differences in mean changes between groups at 12 months. |
| High-density lipoprotein cholesterol | 12 months | Fasting plasma high-density lipoprotein (HDL) cholesterol. Effect measurements: differences in mean changes between groups at 12 months. |
| Very Low-density lipoprotein cholesterol | 12 months | Fasting plasma Very Low-density lipoprotein (VLDL) cholesterol. Effect measurements: differences in mean changes between groups at 12 months. |
| Triglycerides | 12 months | Fasting plasma triglycerides. Effect measurements: differences in mean changes between groups at 12 months. |
| Heart rate | 12 months | Resting heart rate. Effect measurements: differences in mean changes between groups at 12 months. |
| Blood pressure | 12 months | Clinic blood pressure. Effect measurements: differences in mean changes between groups at 12 months. |
| Hemoglobin A1c | 12 months | Hemoglobin A1c (HbA1c). Effect measurements: differences in mean changes between groups at 12 months. |
| The metabolic composite score | 12 months | The metabolic composite score consisting of minimally 0 points and maximally five points (one point per composite; elevated waist circumference, elevated triglycerides, blood pressure, fasting plasma glucose, and reduced high-density lipoprotein), according to the definition and cut-off values of metabolic syndrome by the International Diabetes Federation. A higher score means worse outcomes. Effect measurements: differences in percentage achieving reduction of ≥1 points between groups at 12 months. |
| Cardiovascular risk factors | 12 months | Cardiovascular risk factors as defined below. |
| Proportion of patients achieving a weight loss of ≥10% of initial body weight. | 12 months | Proportion of patients in the intervention group achieving a weight loss of ≥10% of initial body weight vs the standard care group at 12 months. |
| Body weight | 12 months | Absolute and relative changes in body weight. Effect measurements: differences in mean changes between groups at 12 months. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Body composition: Visceral adipose tissue | 12 months | Visceral adipose tissue measured with a bioelectrical impedance analysis. Effect measurements: differences in mean changes between groups at 12 months. |
| Body composition: Skeletal muscle mass. | 12 months | Skeletal muscle mass measured with a bioelectrical impedance analysis. Effect measurements: differences in mean changes between groups at 12 months. |
| Personal recovery - The Brief INSPIRE Measure of Staff Support for Personal Recovery. | 12 months | The Brief INSPIRE Measure of Staff Support for Personal Recovery. Effect measurements: differences in mean changes between groups at 12 months. |
| Personal recovery - The Questionnaire about the Process of Recovery. | 12 months | The Questionnaire about the Process of Recovery (QPR). Effect measurements: differences in mean changes between groups at 12 months. |
| Quality of life - the World Health Organization-5 Well-being index. | 12 months | The World Health Organization (WHO)-5 Well-being index. Effect measurements: differences in mean changes between groups at 12 months. |
| Cognition - The Symbol Digit Modalities Test (SDMT). | 12 months | The Symbol Digit Modalities Test (SDMT). Effect measurements: differences in mean changes between groups at 12 months. |
| Cognition - The Brief Cognitive Assessment Tool in Schizophrenia | 12 months | The Brief Cognitive Assessment Tool in Schizophrenia (B-CATS) comprised of the following: 1. The Trail Making Test. 2. The Letter-Number Span Record Form. 3. The Category Fluency Test. Effect measurements: differences in mean changes between groups at 12 months. |
| Smoking Cessation | 12 months | Smoking cessation amongst persons who are smoking at baseline measured as self-reported cessation for the past 7 days after 12 months. Effect measurements: differences in mean changes between groups at 12 months. |
| Physical activity | 12 months | Physical activity of weekly self-perceived volumes of different intensities and average daily sedentary hours measured with the International Physical Activity Questionnaire. Effect measurements: differences in mean changes between groups at 12 months |
| Appetite | 12 months | Appetite measured with a digital visual analogue scale (VAS) before the first meal at date of baseline measurements and date of measurements after 12 months as minimum 1 and maximally 10 with higher outcomes depicting more appetite. Effect measurements: differences in mean changes between groups at 12 months. |
| Qualitative evaluation | Time from study start to dropout or 12 months | Semi-structured interviews will be conducted following the intervention with patients, who dropped out or completed the intervention, respectively. Patients who complete the intervention will be sampled purposefully to ensure maximum variation in terms of gender, age, and diagnosis, whereas the investigators will interview every patient dropping out (i.e., convenience sampling). Interviews will focus on satisfaction with the delivered care, and sustained motivation for health behaviour change. Data will be analysed by means of inductive-deductive thematic analysis informed by the COM-B model identifying capability, opportunity, and motivation as key factors which need to change in order for a behaviour change intervention to be effective. Adequate sample size for the qualitative evaluation will be guided by information power (also denoted saturation). |
| Body composition: Total body fat percentage | 12 months | Total body fat percentage measured with a bioelectrical impedance analysis. Effect measurements: differences in mean changes between groups at 12 months. |
| Cardiorespiratory fitness | 12 months | Cardiorespiratory fitness assessed by the submaximal Ekblom-Bak test on a mechanically braked cycle ergometer. Effect measurements: differences in mean changes between groups at 12 months. |
Countries
Denmark
Contacts
Primary ContactBjorn H. Ebdrup, MD, Consultant,PhD, Professor,
Outcome results
None listed