Mental IllnessHEAD-MIPNCT05181254
HEAlth Dialogues for Patients With Mental Illness in Primary Care
A study testing health dialogue in people with Mental Illness and Stress, run by Region Skane at 1 site in Sweden.
Trial summary
In the current project, primary health care patients with mental illness such as anxiety, depression, fatigue or sleep disorders will be followed. The study includes both health conversations with the health curve as a systematic work with lifestyle habits, and the biochemical risk marker copeptin with a focus on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Illness, Stress, Fatigue
- What is being tested?
- health dialogue
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2020to 24 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients > 18 years old seeking primary care for mental illness (depression, anxiety, sleep disorders or stress related problems
Who cannot join
- Dementia, not speaking, writing or understanding spoken the Swedish language.
Trial locations and contacts
1 site in 1 country.
About this study
In the current project, primary health care patients with mental illness such as anxiety, depression, fatigue or sleep disorders will be followed. The study includes both health conversations with the health curve as a systematic work with lifestyle habits, and the biochemical risk marker copeptin with a focus on improved lifestyle habits and the development of cardiovascular complications. Participants will be followed up at 12 and 24 months with renewed health interview including the health curve and blood sampling. National registries will be used for a, up to 20 year long follow-up regarding cardiovascular complications and mortality.
Read the detailed description
Patients with mental illness have an increased risk of cardiovascular morbidity and mortality compared to the rest of the population, partly related to unhealthy lifestyle habits. However, not all risk factors for developing cardiovascular disease are known yet. The interest in studies about the importance of copeptin as a biochemical risk factors has increased in recent years.
Objectives:
The main aim with this project is assessment of the effect of Health Dialogue with the health curve (in swedish; Hälsokurvan) on lifestyle habits and cardiovascular risk factors in patients with mental illness in primary care. The second aim is to assess copeptin's prognostic value and to collect blood samples in a biobank for future research on molecular biomarkers with prognostic value for cardiovascular disease.
Work plan:
The study has a prospective observational design. The method with Health Dialogues is previously validated in a Swedish context and is based on a detailed lifestyle questionnaire, blood testing and personalized counselling by a trained health care professional. The patients will be followed with a new Health Dialogue and blood samples after 12 and 24 months and for 20 years with National Registers
Significance:
The effect of Health Dialogues in patients with mental illness is not studied yet. The current fast implementation of the method in the primary care in south of Sweden (the region of Scania) provides a unique opportunity to study this patient group and the expected benefits of Health Dialogues in the long term, to study a potentially useful risk biomarker (copeptin) as well as to build a biobank for future studies on cardiovascular prognostic risk markers.
- Conditions
- Mental Illness, Stress, Fatigue, Sleep Disorder, Depression, Diabetes
- Being tested
- health dialogue
- Keywords
- primary health care, health dialogue, long-term follow-up, mental illness
- Medical subject headings
- Mental Disorders, Fatigue, Sleep Wake Disorders, Depression, Diabetes Mellitus, Cardiomyopathies, Stroke, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health dialogueBehavioural
Also called The health curve
The visual health assessment formulary is based on detailed questions about food, physical activity, heredity, smoking, alcohol, stress and mental illness and measurements such as BMI, blood pressure and blood fats. Patients fill in a web-based questionnaire resulting in a visual colorful scale showing a risk assessment (Figure 1). The Health Dialogue is a prognostic tool that provides an estimate of the increase in risk with current lifestyle habits. The use has shown improvement of lifestyle habits such as smoking cessation, lower intake of fat and higher physical activity level as well as reduced mortality in a long-term follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Health dialogue | Experimental | Patients > 18 years old seeking primary care for mental illness (depression, anxiety, sleep disorders or stress related problems) will be followed at 12 and 24 months from baseline in a first assessment, and after 5 and 10 years with follow-up in national registers in a later phase. The patient will fill out a web-based questionnaire about lifestyle habits before the visit to the health center and will be called for blood sampling and measurement of blood pressure and BMI. A nurse with special training in the Health Dialogue then meets the patient and provides individually tailored advice based on the patient's unique conditions and the risk profile on the Health Dialogue, such as help with smoking cessation, physical activity on prescription (PaR-S), contact with a dietitian, physiotherapist. A continued contact with a psychologist or physician will be planned if necessary Receives: Behavioral: health dialogue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who change their risk profile
Proportion of patients who achieve a change in the risk profile on the Health Dialogue. A positive change ("yes") is defined if a larger number of the variables on the Health Curve have improved than deteriorated. "No" is defined as no change or negative change has taken place.
Measured: 24 months from baseline
Secondary outcomes (22)
Self reported risk change
Proportion of patients who had change between baseline and follow-up in self-reported lifestyle risk assessment
Measured: At 12 and 24 months from baseline
Proportion of smokers and number of cigarettes per day
Proportion of patients, self-reported answers about smoking, Yes (number of cigarettes per day) no, or former
Measured: At baseline and follow-up at 12 and 24 months from baseline.
Referral to smoking cessation
Proportion of patients who have undergone smoking cessation
Measured: At 12 and 24 months from baseline
Time and intensity in physical activity
Proportion of patients in number of minutes self-reported in physical activity per week in different intensity
Measured: At baseline and follow-up at 12 and 24 months from baseline.
Referral PaR-S
Proportion of patients who have received PaR-S
Measured: At 12 and 24 months from baseline
Referral physiotherapist
Proportion of patients who have received referral to physiotherapist
Measured: At 12 and 24 months from baseline
Alcohol consumption
Proportion of patients, self-reported number of glasses with 4 cl 40% alcohol per week
Measured: At baseline and follow-up at 12 and 24 months from baseline.
Metabolic markers
Overnight fasting venous blood sampling. Change in mmol/L from baseline to follow-up of metabolic markers; total cholesterol, triglycerides, high density lipids (HDL), and low density lipids (LDL)
Measured: At 12 and 24 months from baseline
Referral dietitian
Proportion of patients who have received referral to dietitian
Measured: At 12 and 24 months from baseline
Proportion lost to follow-up
Proportion of dropouts / missed follow-ups
Measured: At 12 and 24 months from baseline
Proportion of patients affected with type 2 diabetes
Long time follow-up in registers. Proportion of patients affected of type 2 diabetes: Diagnosis and date of onset of type 2 diabetes mellitus (ICD 10: E11).
Measured: From baseline and up to 20 years follow-up
Proportion of patients affected with myocardial infarction
Long time follow-up in registers. Proportion of patients affected with myocardial infarction: Diagnosis and date of onset of myocardial infarction (MI) (I21)
Measured: From baseline and up to 20 years follow-up
Proportion of patients affected with ischemic stroke
Long time follow-up in registers. Proportion of patients affected of ischemic stroke: Diagnosis and date of onset of ischemic stroke (I63)
Measured: From baseline and up to 20 years follow-up
Proportion of deaths
Long time follow-up in registers. Proportion of patients. Diagnosis and date of death
Measured: From baseline and up to 20 years follow-up
Proportion of cardiovascular death
Long time follow-up in registers. Proportion of patients affected of cardiovascular death: Diagnosis and date of onset of death, cardiovascular death (ICD 10: I)
Measured: From baseline and up to 20 years follow-up
Proportion of patients affected with venous thromboembolism
Long time follow-up in registers. Proportion of patients affected of : Diagnosis and date of onset of venous thromboembolism (I82.0-I82.3, I82.8, I82.9 \& I82.8W)
Measured: From baseline and up to 20 years follow-up
Proportion of patients affected by MACE (Myocardial infarction, stroke or cardiovascular death)
Long time follow-up in registers. Proportion of patients affected of Myocardial infarction, stroke or cardiovascular death (MACE) up to 20 years from baseline: Diagnosis and date of first onset of ischemic stroke (I63), death, cardiovascular death (ICD 10: I), combined to the composite outcome measure MACE (MI, stroke or cardiovascular death).
Measured: From baseline and up to 20 years follow-up
Co-peptin
Measured at baseline in pmol/L. Blood sampling after overnight fasting.
Measured: At baseline and follow-up at 12 and 24 months from baseline.
Blood glucose
Fasting blood glucose from venous blood sampling in mmol/L
Measured: At baseline and follow-up at 12 and 24 months from baseline.
BMI
BMI (weight and height will be combined to report BMI in kg/m^2)
Measured: At baseline and follow-up at 12 and 24 months from baseline.
Waist hip ratio (WHR)
WHR will be calculated by the ratio between waist in cm and and hip in cm
Measured: At baseline and follow-up at 12 and 24 months from baseline.
Blood pressure
Measured (mmHg), sitting at right arm after 10 minutes of resting with both feet on the floor.
Measured: At baseline and follow-up at 12 and 24 months from baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start1 Jan 2020
- Primary completion24 Nov 2025
- Study completion24 Nov 2025
Why it stopped: Lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University
- Responsible party
- Sponsor
- Investigators
- Miriam Pikkemaat, PhD, Study chair, Lund University/ Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181254
- Sponsor's protocol ID
- 2021-10-28
- Acronym
- HEAD-MIP
- Status last verified
- Nov 2025
- First submitted
- 31 Oct 2021
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gibson M, Carek PJ, Sullivan B. Treatment of co-morbid mental illness in primary care: how to minimize weight gain, diabetes, and metabolic syndrome. Int J Psychiatry Med. 2011;41(2):127-42. doi: 10.2190/PM.41.2.c.
PubMed 21675345Jao NC, Robinson LD, Kelly PJ, Ciecierski CC, Hitsman B. Unhealthy behavior clustering and mental health status in United States college students. J Am Coll Health. 2019 Nov-Dec;67(8):790-800. doi: 10.1080/07448481.2018.1515744. Epub 2018 Nov 28.
PubMed 30485154Wu Q, Kling JM. Depression and the Risk of Myocardial Infarction and Coronary Death: A Meta-Analysis of Prospective Cohort Studies. Medicine (Baltimore). 2016 Feb;95(6):e2815. doi: 10.1097/MD.0000000000002815.
PubMed 26871852Bonow RO. Primary prevention of cardiovascular disease: a call to action. Circulation. 2002 Dec 17;106(25):3140-1. doi: 10.1161/01.cir.0000048067.86569.e1. No abstract available.
PubMed 12485965Stumbo SP, Yarborough BJH, Yarborough MT, Green CA. Perspectives on Providing And Receiving Preventive Health Care From Primary Care Providers and Their Patients With Mental Illnesses. Am J Health Promot. 2018 Nov;32(8):1730-1739. doi: 10.1177/0890117118763233. Epub 2018 Apr 15.
PubMed 29658287Neeleman J, Oldehinkel AJ, Ormel J. Positive life change and remission of non-psychotic mental illness. A competing outcomes approach. J Affect Disord. 2003 Sep;76(1-3):69-78. doi: 10.1016/s0165-0327(02)00068-x.
PubMed 12943935Ronngren Y, Bjork A, Kristiansen L, Haage D, Enmarker I, Audulv A. Meeting the needs? Perceived support of a nurse-led lifestyle programme for young adults with mental illness in a primary health-care setting. Int J Ment Health Nurs. 2018 Feb;27(1):390-399. doi: 10.1111/inm.12333. Epub 2017 Apr 4.
PubMed 28374967Forsyth A, Deane FP, Williams P. A lifestyle intervention for primary care patients with depression and anxiety: A randomised controlled trial. Psychiatry Res. 2015 Dec 15;230(2):537-44. doi: 10.1016/j.psychres.2015.10.001. Epub 2015 Oct 3.
PubMed 26453120Lingfors H, Persson LG, Lindstrom K, Bengtsson C, Lissner L. Effects of a global health and risk assessment tool for prevention of ischemic heart disease in an individual health dialogue compared with a community health strategy only results from the Live for Life health promotion programme. Prev Med. 2009 Jan;48(1):20-4. doi: 10.1016/j.ypmed.2008.10.009. Epub 2008 Nov 1.
PubMed 19013188Farnkvist L, Olofsson N, Weinehall L. Did a health dialogue matter? Self-reported cardiovascular disease and diabetes 11 years after health screening. Scand J Prim Health Care. 2008;26(3):135-9. doi: 10.1080/02813430802113029.
PubMed 18609252Persson LG, Lindstrom K, Lingfors H, Bengtsson C, Lissner L. Cardiovascular risk during early adult life. Risk markers among participants in "Live for Life" health promotion programme in Sweden. J Epidemiol Community Health. 1998 Jul;52(7):425-32. doi: 10.1136/jech.52.7.425.
PubMed 9799876Lingfors H, Lindstrom K, Persson LG, Bengtsson C, Lissner L. Lifestyle changes after a health dialogue. Results from the Live for Life health promotion programme. Scand J Prim Health Care. 2003 Dec;21(4):248-52. doi: 10.1080/02813430310003282.
PubMed 14695077Persson LG, Lingfors H, Nilsson M, Molstad S. The possibility of lifestyle and biological risk markers to predict morbidity and mortality in a cohort of young men after 26 years follow-up. BMJ Open. 2015 May 6;5(5):e006798. doi: 10.1136/bmjopen-2014-006798.
PubMed 25948404Lingfors 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.
PubMed 30696668Enhorning S, Wang TJ, Nilsson PM, Almgren P, Hedblad B, Berglund G, Struck J, Morgenthaler NG, Bergmann A, Lindholm E, Groop L, Lyssenko V, Orho-Melander M, Newton-Cheh C, Melander O. Plasma copeptin and the risk of diabetes mellitus. Circulation. 2010 May 18;121(19):2102-8. doi: 10.1161/CIRCULATIONAHA.109.909663. Epub 2010 May 3.
PubMed 20439785
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEAlth Dialogues for Patients With Mental Illness in Primary Care
- ClinicalTrials.gov ID
- NCT05181254
- Acronym / sponsor ID
- HEAD-MIP / 2021-10-28
- Conditions
- Mental Illness, Stress, Fatigue, Sleep Disorder, Depression, Diabetes
- Keywords
- primary health care, health dialogue, long-term follow-up, mental illness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding.
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Lund University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 24 Nov 2025 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the current project, primary health care patients with mental illness such as anxiety, depression, fatigue or sleep disorders will be followed. The study includes both health conversations with the health curve as a systematic work with lifestyle habits, and the biochemical risk marker copeptin with a focus on improved lifestyle habits and the development of cardiovascular complications. Participants will be followed up at 12 and 24 months with renewed health interview including the health curve and blood sampling. National registries will be used for a, up to 20 year long follow-up regarding cardiovascular complications and mortality.
Detailed description
Patients with mental illness have an increased risk of cardiovascular morbidity and mortality compared to the rest of the population, partly related to unhealthy lifestyle habits. However, not all risk factors for developing cardiovascular disease are known yet. The interest in studies about the importance of copeptin as a biochemical risk factors has increased in recent years.
Objectives:
The main aim with this project is assessment of the effect of Health Dialogue with the health curve (in swedish; Hälsokurvan) on lifestyle habits and cardiovascular risk factors in patients with mental illness in primary care. The second aim is to assess copeptin's prognostic value and to collect blood samples in a biobank for future research on molecular biomarkers with prognostic value for cardiovascular disease.
Work plan:
The study has a prospective observational design. The method with Health Dialogues is previously validated in a Swedish context and is based on a detailed lifestyle questionnaire, blood testing and personalized counselling by a trained health care professional. The patients will be followed with a new Health Dialogue and blood samples after 12 and 24 months and for 20 years with National Registers
Significance:
The effect of Health Dialogues in patients with mental illness is not studied yet. The current fast implementation of the method in the primary care in south of Sweden (the region of Scania) provides a unique opportunity to study this patient group and the expected benefits of Health Dialogues in the long term, to study a potentially useful risk biomarker (copeptin) as well as to build a biobank for future studies on cardiovascular prognostic risk markers.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health dialogue | Experimental | Behavioral: health dialoguePatients > 18 years old seeking primary care for mental illness (depression, anxiety, sleep disorders or stress related problems) will be followed at 12 and 24 months from baseline in a first assessment, and after 5 and 10 years with follow-up in national registers in a later phase. The patient will fill out a web-based questionnaire about lifestyle habits before the visit to the health center and will be called for blood sampling and measurement of blood pressure and BMI. A nurse with special training in the Health Dialogue then meets the patient and provides individually tailored advice based on the patient's unique conditions and the risk profile on the Health Dialogue, such as help with smoking cessation, physical activity on prescription (PaR-S), contact with a dietitian, physiotherapist. A continued contact with a psychologist or physician will be planned if necessary |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients > 18 years old seeking primary care for mental illness (depression, anxiety, sleep disorders or stress related problems
Key exclusion criteria (1 listed)
- Dementia, not speaking, writing or understanding spoken the Swedish language.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| health dialogueAlso: The health curveThe visual health assessment formulary is based on detailed questions about food, physical activity, heredity, smoking, alcohol, stress and mental illness and measurements such as BMI, blood pressure and blood fats. Patients fill in a web-based questionnaire resulting in a visual colorful scale showing a risk assessment (Figure 1). The Health Dialogue is a prognostic tool that provides an estimate of the increase in risk with current lifestyle habits. The use has shown improvement of lifestyle habits such as smoking cessation, lower intake of fat and higher physical activity level as well as reduced mortality in a long-term follow-up. | Behavioural | Health dialogue |
Primary outcome
Proportion of patients who change their risk profile
Time frame: 24 months from baseline
Proportion of patients who achieve a change in the risk profile on the Health Dialogue. A positive change ("yes") is defined if a larger number of the variables on the Health Curve have improved than deteriorated. "No" is defined as no change or negative change has taken place.
22 secondary outcomes
Self reported risk change
Time frame: At 12 and 24 months from baseline
Proportion of smokers and number of cigarettes per day
Time frame: At baseline and follow-up at 12 and 24 months from baseline.
Referral to smoking cessation
Time frame: At 12 and 24 months from baseline
Time and intensity in physical activity
Time frame: At baseline and follow-up at 12 and 24 months from baseline.
Referral PaR-S
Time frame: At 12 and 24 months from baseline
Referral physiotherapist
Time frame: At 12 and 24 months from baseline
Alcohol consumption
Time frame: At baseline and follow-up at 12 and 24 months from baseline.
Metabolic markers
Time frame: At 12 and 24 months from baseline
Referral dietitian
Time frame: At 12 and 24 months from baseline
Proportion lost to follow-up
Time frame: At 12 and 24 months from baseline
Proportion of patients affected with type 2 diabetes
Time frame: From baseline and up to 20 years follow-up
Proportion of patients affected with myocardial infarction
Time frame: From baseline and up to 20 years follow-up
Proportion of patients affected with ischemic stroke
Time frame: From baseline and up to 20 years follow-up
Proportion of deaths
Time frame: From baseline and up to 20 years follow-up
Proportion of cardiovascular death
Time frame: From baseline and up to 20 years follow-up
Proportion of patients affected with venous thromboembolism
Time frame: From baseline and up to 20 years follow-up
Proportion of patients affected by MACE (Myocardial infarction, stroke or cardiovascular death)
Time frame: From baseline and up to 20 years follow-up
Co-peptin
Time frame: At baseline and follow-up at 12 and 24 months from baseline.
Blood glucose
Time frame: At baseline and follow-up at 12 and 24 months from baseline.
BMI
Time frame: At baseline and follow-up at 12 and 24 months from baseline.
Waist hip ratio (WHR)
Time frame: At baseline and follow-up at 12 and 24 months from baseline.
Blood pressure
Time frame: At baseline and follow-up at 12 and 24 months from baseline.
Results and safety
The study was stopped early (reason given: Lack of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 21675345Gibson M, Carek PJ, Sullivan B. Treatment of co-morbid mental illness in primary care: how to minimize weight gain, diabetes, and metabolic syndrome. Int J Psychiatry Med. 2011;41(2):127-42. doi: 10.2190/PM.41.2.c.
- Background: PubMed 30485154Jao NC, Robinson LD, Kelly PJ, Ciecierski CC, Hitsman B. Unhealthy behavior clustering and mental health status in United States college students. J Am Coll Health. 2019 Nov-Dec;67(8):790-800. doi: 10.1080/07448481.2018.1515744. Epub 2018 Nov 28.
- Background: PubMed 26871852Wu Q, Kling JM. Depression and the Risk of Myocardial Infarction and Coronary Death: A Meta-Analysis of Prospective Cohort Studies. Medicine (Baltimore). 2016 Feb;95(6):e2815. doi: 10.1097/MD.0000000000002815.
- Background: PubMed 12485965Bonow RO. Primary prevention of cardiovascular disease: a call to action. Circulation. 2002 Dec 17;106(25):3140-1. doi: 10.1161/01.cir.0000048067.86569.e1. No abstract available.
- Background: PubMed 29658287Stumbo SP, Yarborough BJH, Yarborough MT, Green CA. Perspectives on Providing And Receiving Preventive Health Care From Primary Care Providers and Their Patients With Mental Illnesses. Am J Health Promot. 2018 Nov;32(8):1730-1739. doi: 10.1177/0890117118763233. Epub 2018 Apr 15.
- Background: PubMed 12943935Neeleman J, Oldehinkel AJ, Ormel J. Positive life change and remission of non-psychotic mental illness. A competing outcomes approach. J Affect Disord. 2003 Sep;76(1-3):69-78. doi: 10.1016/s0165-0327(02)00068-x.
- Background: PubMed 28374967Ronngren Y, Bjork A, Kristiansen L, Haage D, Enmarker I, Audulv A. Meeting the needs? Perceived support of a nurse-led lifestyle programme for young adults with mental illness in a primary health-care setting. Int J Ment Health Nurs. 2018 Feb;27(1):390-399. doi: 10.1111/inm.12333. Epub 2017 Apr 4.
- Background: PubMed 26453120Forsyth A, Deane FP, Williams P. A lifestyle intervention for primary care patients with depression and anxiety: A randomised controlled trial. Psychiatry Res. 2015 Dec 15;230(2):537-44. doi: 10.1016/j.psychres.2015.10.001. Epub 2015 Oct 3.
- Background: PubMed 19013188Lingfors H, Persson LG, Lindstrom K, Bengtsson C, Lissner L. Effects of a global health and risk assessment tool for prevention of ischemic heart disease in an individual health dialogue compared with a community health strategy only results from the Live for Life health promotion programme. Prev Med. 2009 Jan;48(1):20-4. doi: 10.1016/j.ypmed.2008.10.009. Epub 2008 Nov 1.
- Background: PubMed 18609252Farnkvist L, Olofsson N, Weinehall L. Did a health dialogue matter? Self-reported cardiovascular disease and diabetes 11 years after health screening. Scand J Prim Health Care. 2008;26(3):135-9. doi: 10.1080/02813430802113029.
- Background: PubMed 9799876Persson LG, Lindstrom K, Lingfors H, Bengtsson C, Lissner L. Cardiovascular risk during early adult life. Risk markers among participants in "Live for Life" health promotion programme in Sweden. J Epidemiol Community Health. 1998 Jul;52(7):425-32. doi: 10.1136/jech.52.7.425.
- Background: PubMed 14695077Lingfors H, Lindstrom K, Persson LG, Bengtsson C, Lissner L. Lifestyle changes after a health dialogue. Results from the Live for Life health promotion programme. Scand J Prim Health Care. 2003 Dec;21(4):248-52. doi: 10.1080/02813430310003282.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miriam Pikkemaat, PhD study chair
Lund University/ Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health dialogue in people with Mental Illness and Stress, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who change their risk profile (time frame: 24 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05181254, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.