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NCT Number: NCT05681767

Motivational Multicomponent Lifestyle Interventions as a Supportive Treatment for Depression in Primary Health Care

The investigators aim to examine whether a motivational multicomponent lifestyle intervention as a supportive treatment for depression has a beneficial effect on recovery from depression in a primary health care setting.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kuopio Health Center

Kuopio, Finland

Location status: Recruiting

Location contact

Pekka Mäntyselkä, Professor

CONTACT

Ulla Mikkonen, MD

CONTACT

About this study

Depression causes a significant global burden of disease. Among depressed individuals, poor lifestyles, such as physical inactivity, unhealthy diet, and smoking, are common and play a role in the development and maintenance of depression. Robust research evidence recommends applying one-component lifestyle interventions that focus on factors such as a healthy diet or exercise, as a supportive treatment for depression. Currently, however, there is increasing interest in identifying the most effective multicomponent lifestyle intervention that targets more than one unhealthy lifestyle simultaneously in order to reduce depressive symptoms.

The study aims to examine whether a motivational multicomponent lifestyle intervention as a supportive treatment for depression has a beneficial effect on recovery from depression in a primary health care setting. The specific study questions are as follows:

  • What is the effect of the intervention on depressive symptoms at 3- and 12-month follow-ups?
  • What is the effect of the intervention on mental well-being at 3- and 12-month follow-ups?
  • What kind of physical health do depressed patients in primary health care have? What kinds of effects does the intervention have on common physical health risk factors at 12- and 24- month follow-ups?
  • What is the effect of the intervention on health-related quality of life?
  • What is the cost-effectiveness of the intervention?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults ≥ 18 years
  • depression (ICD-10, F32-F33)
  • Beck Depression Inventory (BDI-1A) ≥ 10 points
  • the initiation of treatment in a primary health care center

Exclusion criteria

  • bipolar disorder
  • psychosis
  • substance abuse
  • pregnancy or lactation
  • a long-term rehabilitative psychotherapy.

Treatment and study plan

Motivational multicomponent lifestyle intervention + Treatment as usual

Behavioral

Study intervention and treatment as usual

The study intervention is a multicomponent lifestyle intervention that targets exercise, diet, and stress management, and is conducted by motivational interviewing. The study nurse provides the study intervention. The intervention is conducted by motivational interviewing and includes the key elements of lifestyle interventions identified as effective (assessment of behavior at the baseline, giving information and advising, individualized goal setting, setting an action plan, monitoring a behavioral change, and giving feedback).

The intervention consists of individual appointments (2 x 45-60 min) and a telephone session ( 2 x 15 min) for three months. The participants receive a short educational guide (A4) on the lifestyle behavior recommendations.

Treatment as Usual

Other

Treatment as usual

Primary outcomes

  1. Change in Beck Depression Inventory (BDI) scores

    Time frame: Change from baseline at 3, 12 and 24 months

    Depressive symptoms

  2. Change in the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) scores

    Time frame: Change from baseline at 3, 12 and 24 months

    Mental Wellbeing

  3. Change in 15D scores

    Time frame: Change from baseline at 3, 12 and 24 months

    Health-Related Quality of Life

Secondary outcomes

  1. Change in Perceived Stress Scale (PSS-10) scores

    Time frame: Change from baseline at 3, 12 and 24 months

    Stress

  2. Change in Insomnia Severity Index (ISI) scores

    Time frame: Change from baseline at 3, 12 and 24 months

    Insomnia

  3. Change in Numeric Rating Scale for pain

    Time frame: Change from baseline at 3, 12 and 24 months

    Pain

  4. Change in Overall Anxiety Severity and Impairment Scale (OASIS) scores

    Time frame: Change from baseline at 3, 12 and 24 months

    Anxiety

  5. Change in Blood lipid levels

    Time frame: Change from baseline at 12 and 24 months

    P-Kol, P-KOL-LDL, P-KOL-HDL, P-Trigly

  6. Change in weight/body mass index (BMI)

    Time frame: Change from baseline at 3, 12 and 24 months

    Change in measured weight/BMI

  7. Change in waist circumference

    Time frame: Change from baseline at 3, 12 and 24 months

    Waist (centimeters)

  8. Change in Blood pressure (diastolic and systolic)

    Time frame: Change from baseline at 3, 12, and 24 months

    Blood pressure (diastolic and systolic)

  9. Change in Blood glucose levels

    Time frame: Change from baseline at 12 and 24 months

    P-Glucose and glycated haemoglobin

Study contacts

Contact information is provided by the study sponsor or research team.

Pekka Mäntyselkä

CONTACT

[email protected]

+35850449436

Ulla Mikkonen

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Collaborators

  • City of Kuopio
  • University of Eastern Finland
  • University of Oslo

Registry information

Acronym: DEPKuopio

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jan 12, 2023
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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