HEAlth Dialogues for Patients With Mental Illness in Primary Care

NCT05181254 | Terminated

• 1 other identifier: 2021-10-28
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Mental Illness; Stress; Fatigue; Sleep Disorder; Diabetes; Myocardial Disease; Stroke; Death; Depression

Keywords

primary health care; health dialogue; long-term follow-up; mental illness

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months from baseline

Secondary Outcomes (22)

• Self reported risk change

  At 12 and 24 months from baseline

• Proportion of smokers and number of cigarettes per day

  At baseline and follow-up at 12 and 24 months from baseline.

• Referral to smoking cessation

  At 12 and 24 months from baseline

• Time and intensity in physical activity

  At baseline and follow-up at 12 and 24 months from baseline.

• Referral PaR-S

  At 12 and 24 months from baseline

Study Arms (1)

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

Behavioral: health dialogue

Interventions

health dialogue BEHAVIORAL

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.

Also known as: The health curve

Health dialogue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients \> 18 years old seeking primary care for mental illness (depression, anxiety, sleep disorders or stress related problems

You may not qualify if:

• Dementia, not speaking, writing or understanding spoken the Swedish language.

Sponsors & Collaborators

• Region Skane: lead
• Lund University: collaborator

Study Sites (1)

Peter Nymberg

Helsingborg, Region Skane, 253 62, Sweden

Location

Related Publications (24)

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• Persson 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.

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• 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 BACKGROUND

• Enhorning 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.

  PMID: 20439785 BACKGROUND

• Tasevska I, Enhorning S, Persson M, Nilsson PM, Melander O. Copeptin predicts coronary artery disease cardiovascular and total mortality. Heart. 2016 Jan;102(2):127-32. doi: 10.1136/heartjnl-2015-308183. Epub 2015 Dec 9.

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• Pikkemaat M, Melander O, Bengtsson Bostrom K. Association between copeptin and declining glomerular filtration rate in people with newly diagnosed diabetes. The Skaraborg Diabetes Register. J Diabetes Complications. 2015 Nov-Dec;29(8):1062-5. doi: 10.1016/j.jdiacomp.2015.07.006. Epub 2015 Jul 9.

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• Siegenthaler J, Walti C, Urwyler SA, Schuetz P, Christ-Crain M. Copeptin concentrations during psychological stress: the PsyCo study. Eur J Endocrinol. 2014 Dec;171(6):737-42. doi: 10.1530/EJE-14-0405. Epub 2014 Sep 23.

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• Kaczmarczyk M, Spitzer C, Wingenfeld K, Wiedemann K, Kuehl LK, Schultebraucks K, Deuter CE, Otte C. No association between major depression with and without childhood adversity and the stress hormone copeptin. Eur J Psychotraumatol. 2020 Nov 2;11(1):1837511. doi: 10.1080/20008198.2020.1837511.

  PMID: 33244366 BACKGROUND

• Agorastos A, Sommer A, Heinig A, Wiedemann K, Demiralay C. Vasopressin Surrogate Marker Copeptin as a Potential Novel Endocrine Biomarker for Antidepressant Treatment Response in Major Depression: A Pilot Study. Front Psychiatry. 2020 May 20;11:453. doi: 10.3389/fpsyt.2020.00453. eCollection 2020.

  PMID: 32508691 BACKGROUND

• Milos Nymberg V, Pikkemaat M, Calling S, Nymberg P. HEAD-MIP-(HEAlth Dialogues for patients with Mental Illness in Primary care)-a feasibility study. Pilot Feasibility Stud. 2023 Sep 28;9(1):167. doi: 10.1186/s40814-023-01391-2.

  PMID: 37770967 DERIVED

• Pikkemaat M, Nymberg VM, Nymberg P. Structured assessment of modifiable lifestyle habits among patients with mental illnesses in primary care. Sci Rep. 2022 Jul 19;12(1):12292. doi: 10.1038/s41598-022-16439-1.

  PMID: 35853972 DERIVED

MeSH Terms

Conditions

Mental Disorders; Fatigue; Sleep Wake Disorders; Depression; Diabetes Mellitus; Cardiomyopathies; Stroke; Death

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations; Behavioral Symptoms; Behavior; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Pathologic Processes

Study Officials

• Miriam Pikkemaat, PhD

  Lund University/ Region Skane

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2021
• First Posted: January 6, 2022
• Study Start: January 1, 2020
• Primary Completion: November 24, 2025
• Study Completion: November 24, 2025
• Last Updated: May 1, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)