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PsychosesNCT07888894

Targeted Health Dialogues for Individuals With Psychosis Spectrum Disorders

A study testing Targeted Health Dialogues in people with Psychoses and Metabolic Syndrome, run by Uppsala University.

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psychoses, Metabolic Syndrome
What is being tested?
Targeted Health Dialogues
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Oct 2026to 1 Dec 2030
Phase
Interventional

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

  • Age above 18.
  • Diagnosed with psychotic spectrum disorders (PSD) (schizophrenia, schizoaffective, psychosis NOS)
  • Mentally stable in their illness
  • Adequate Swedish language skills.

Who cannot join

  • -

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Katarina Asplund, PhD, MDspecialist i psychiatry contact

004618611000

katarina.danielsson@akademiska.se

About this study

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.

Read the detailed description

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

Being tested
Targeted Health Dialogues
Medical subject headings
Psychotic Disorders, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Targeted Health DialoguesBehavioural

    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.

Study groups in NCT07888894
Study groupRoleWhat they receive
Targeted health dialoguesExperimentalTargeted 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.
Receives: Behavioral: Targeted Health Dialogues

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes from baseline in Body Mass Index after 12 months

    Measured: From enrollment to the end of the sudy at 12 months

Secondary outcomes (7)
  1. 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.

    Measured: From enrollment to the end of the study after 12 months

  2. Changes from baseline in HbA1C mmol/mol at 12 months

    Measured: From enrollment to the end of the study at 12 months

  3. Changes from baseline in waist-to hip ratio after 12 months

    Measured: From enrollment to the end of the study at 12 months

  4. Canges from baseline in blood preassure at 12 months

    Measured: From enrollment to the end of treatment at 12 months

  5. 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

    Measured: From enrollment to the end of the study at 12 months

  6. Changes from baseline in fasting plasma glucose at 12 months

    Bloodtest measuring fasting plasma glucose in mmol/L

    Measured: From enrollment to end of the study at 12 months

  7. 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

    Measured: From enrollment to end of the study at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion1 Dec 2030 (estimated)
  4. Study completion1 Dec 2030 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07888894
Sponsor's protocol ID
2026-04180-01
Status last verified
Oct 2026
First submitted
2 Oct 2026
Last updated
22 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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