An interventional study of Targeted Health Dialogues in Psychoses and Metabolic Syndrome, sponsored by Uppsala University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Uppsala University · Not applicable, Interventional, and Treatment
People with psychotic disorders are at a higher risk of premature death than the general population. Adverse lifestyle factors contribute to this reduced life expectancy; such factors may include high consumption of tobacco and other substances, physical inactivity, and obesity. These lifestyle factors increase the risk of type 2 diabetes, cardiovascular disease, and cancer-conditions known as non-communicable diseases (NCDs). Primary care offers an evidence-based and cost-effective method known as "Targeted Health Dialogues" (Riktade hälsosamtal), aimed at individuals in their forties to motivate lifestyle changes. Previous studies indicate that people with psychotic disorders-particularly those with lower levels of social functioning, comorbidities, or concerns about stigma-frequently miss appointments at primary care centers, whereas in outpatient psychiatric care, they may establish long-term therapeutic relationships with specialist nurses. There is thus a need to evaluate the feasibility of using this evidence-based, nurse-led method-Targeted Health Dialogues-to support healthy lifestyle changes and reduce NCD risk among people with psychotic disorders receiving outpatient psychiatric care. The findings of this study will provide a basis for designing nurse-led lifestyle support interventions for individuals with psychotic disorders.
In Sweden, individuals with schizophrenia are often treated at a psychiatric outpatient clinic where staff and patients build therapeutic relationships. Therapeutic relationships between patients and staff are considered essential for high-quality care in those settings and can contribute to patients adhering to treatment even during extended care periods, common in psyotic spectrum disorders. In Sweden, during psychiatric outpatient care, data is collected yearly regarding self-reported health-related quality of life, alcohol and drug consumption, smoking habits, length, weight, blood pressure, lipid profile, fasting glucose and HbA1c mmol/mol value. All data, together with information on completed health consultations (not specifically defined), shall be reported for each patient to the Swedish bipolar and psychosis registry. Since individuals with schizophrenia may disengage from community care but often stay in contact with a specialist mental health nurse at a psychiatric outpatient clinic, it may be possible to integrate targeted health dialogues during consultation in outpatient care in order to support positive lifestyle changes to prevent noncommunicable diseases.
Project description A prospective approach will be used in order to investigate possible associations between exposure to targeted health dialogues and blood tests collected from patients' records and selected health-related measures. Moreover, interviews will be performed with participants about their experiences and the perceived effects of targeted health dialogues. Age, sex, diagnosis, disease duration, pharmacological treatment, and number of visits will beretrieved from the patient records during project duration.
The study will include the following measurements. Blood test values collected from patient records (lipid profile (total-cholesterol, triglycerides, HDL-Cholesterol and LDL-cholesterol) fasting glucose, HbA1C). Blood pressure, waist-to hip ratio, Body Mass Index (BMI). Health literacy, S-FHL (Skala för funktionell hälsolitteracitet) (Wångdahl \& Mårtensson, 2015), to support the specialist nurses in the adjustment of the dialogue to participants' ability to comprehend, and utilize health information. Three-dimensional Health questionnaire rendering The Health curve (Hälsokurvan).
Health-related quality of life (HRQoL) measures (RAND-36 and EQ VAS). Participants will be one-on-one interviewed regarding perception of feasibility and acceptability, and any perceived effects. Sample The sample will be consecutive. Inclusion criteria: adult patients with psychotic spectrum disorders (PSD) (schizophrenia, schizoaffective, psychosis NOS), mentally stable in their illness, and adequate Swedish language skills.
Targeted health dialogues Targeted health dialogues will be implemented utilizing a visual tool, the "Health curve" (Hälsokurvan). The "Health curve" displays the individual health profile, which is derived from participants' responses to three health domains. The domains under investigation encompass Dietary patterns, Levels of physical activity, and aggregated Alcohol and tobacco use, as well as Psychosocial circumstances and Hereditary predispositions to diabetes and cardiovascular diseases. The "Health curve" has three colors, ranging from green to red, with red indicating high risk. The conversation will be conducted as a person-centred dialogue, focusing on the participant's own motivation and goals for lifestyle changes.
Staff training Nursing staff will participate in a one-hour education and training session on using targeted health dialogues. The education and training sessions will be led by a nurse specialized in mental health care.
Settings and procedures Patients with a history of PSD (> 5 years from admission) cared for at any psychiatric outpatient clinic in Region Uppsala will be invited to participate in the intervention. A power analysis was conducted to estimate the required sample size to enable comparisons of mean differences given an effect size of 0.5. A total of 60 participants will be approached to account for an anticipated attrition rate of approximately 30%. Those who meet the inclusion criteria will receive information about the study and an invitation to participate in connection with a call to their routine 1-year follow-up. Informed consent will be obtained when participants come to the clinic for the follow-up at baseline. After giving informed consent, information about the participant's diagnosis, disease duration, number of visits, and blood test values lipid profile (total-cholesterol, triglycerides, HDL Cholesterol and LDL-cholesterol) fasting glucose, HbA1C will be retrieved from the patient records. These blood tests are part of ordinary routine care before the yearly follow-up visit at the outpatient clinic. Demographic information will be retrieved from patient records and participating patients will answer the health literacy questionnaire, two HRQoL questionnaires, and the health questionnaire. This procedure will take approximately 30 minutes, followed by a one-hour-long targeted health dialogue. After this first health dialogue, participants will have their blood pressure, waist-to-hip ratio and Body Mass Index (BMI) assessed. At 6 months, participants will answer the health questionnaire and participate in a one-hour long targeted health dialogue. Afterwards participants will have their blood pressure, waist-to hip ratio and BMI assessed.
When the patients come to their routine 1-year follow-up, after 12 months from baseline, blood test values lipid profile (total-cholesterol, triglycerides, HDL-Cholesterol and LDL cholesterol) fasting glucose, HbA1C will be retrieved from the patient records. Participants will answer the two HRQoL questionnaires and the health questionnaire and have their blood pressure, waist-to-hip ratio and Body Mass Index (BMI) assessed. All patients will also be invited to participate in audio-recorded one-on-one interviews regarding perception of feasibility and acceptability, and any perceived effects of the targeted health dialogue. The interview will be conducted at the outpatient clinic, online, or at telephone according to the participants choice.
Analyses Statistical analyses will include paired tests of changes over time in selected variables, between time points, and strength and direction of correlations between variables. Regression analyses will be used to assess predictive value of patient caracteristics at baselinewith regard to the defined outcome measures. Data from the concluding interviews will be transcribed verbatim and a collaborative qualitative data analysis will be performed
1,655 studies on the registry are indexed under Psychotic Disorders; 298 are open to participants now.
This study's planned enrollment of 60 is below the median of 68 across 1,358 interventional studies indexed under Psychotic Disorders.
Browse Psychotic Disorders studies →Uppsala University is the lead sponsor of 390 studies on the registry; 86 are open to participants now.
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Exclusion Criteria:
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Targeted health dialogues will be implemented utilizing a visual tool, the "Health curve" (Hälsokurvan). The "Health curve" displays the individual health profile, which is derived from participants' responses to three health domains. The domains under investigation encompass Dietary patterns, Levels of physical activity, and aggregated Alcohol and tobacco use, as well as Psychosocial circumstances and Hereditary predispositions to diabetes and cardiovascular diseases. The "Health curve" has three colors, ranging from green to red, with red indicating high risk. The conversation will be conducted as a person-centred dialogue, focusing on the participant's own motivation and goals for lifestyle changes.
Behavioral: Targeted Health Dialogues
Targeted health dialogues will be implemented utilizing a visual tool, the "Health curve" (Hälsokurvan). The "Health curve" displays the individual health profile, which is derived from participants' responses to three health domains. The domains under investigation encompass Dietary patterns, Levels of physical activity, and aggregated Alcohol and tobacco use, as well as Psychosocial circumstances and Hereditary predispositions to diabetes and cardiovascular diseases. The "Health curve" has three colors, ranging from green to red, with red indicating high risk . The conversation will be conducted as a person-centred dialogue, focusing on the participant's own motivation and goals for lifestyle changes.
Changes from baseline in Body Mass Index after 12 months
Time frame: From enrollment to the end of the sudy at 12 months
Canges from baseline in Lipid profile at 12 months
Lipid profile is blood test values collected from patient records. Lipid profile include total-cholesterol, triglycerides, HDL-Cholesterol and LDL-cholesterol.
Time frame: From enrollment to the end of the study after 12 months
Changes from baseline in HbA1C mmol/mol at 12 months
Time frame: From enrollment to the end of the study at 12 months
Changes from baseline in waist-to hip ratio after 12 months
Time frame: From enrollment to the end of the study at 12 months
Canges from baseline in blood preassure at 12 months
Time frame: From enrollment to the end of treatment at 12 months
Changes from baseline in EuroQol Visual Analogue Scale at 12 months
Range from 0 to 100. 0 represents worse possible healthstatus and 100 represents best possible health status
Time frame: From enrollment to the end of the study at 12 months
Changes from baseline in fasting plasma glucose at 12 months
Bloodtest measuring fasting plasma glucose in mmol/L
Time frame: From enrollment to end of the study at 12 months
Changes from baseline in RAND 36-Item Health Survey at 12 months
8 health dimension are measured Range from from 0-100. Where a higher score means better function/health
Time frame: From enrollment to end of the study at 12 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2030, 50 months later.
Of 502 non-industry interventional studies with no phase under Psychotic Disorders, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 51. This study's planned 50 months is above that.
Counting every sponsor, half of 504 studies reached it within 33 months; a quarter within 18 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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