DepressionDEPKuopioNCT05681767
Motivational Multicomponent Lifestyle Interventions as a Supportive Treatment for Depression in Primary Health Care
A study testing Motivational multicomponent lifestyle intervention + Treatment as usual and Treatment as usual in people with Depression, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Motivational multicomponent lifestyle intervention + Treatment as usual and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteFinland
- Study dates
- 21 Nov 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- bipolar disorder
- psychosis
- substance abuse
- pregnancy or lactation
- a long-term rehabilitative psychotherapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ulla Mikkonen contact
Finland1 site, 1 recruiting
- Recruiting
Kuopio Health Center
Kuopio
Ulla Mikkonen, MD
Pekka Mäntyselkä, Professor
About this study
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.
Read the detailed description
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?
- Conditions
- Depression
- Being tested
- Motivational multicomponent lifestyle intervention + Treatment as usual, Treatment as usual
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational multicomponent lifestyle intervention + Treatment as usualBehavioural
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 usualOther
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Motivational multicomponent lifestyle intervention + treatment as usual Receives: Behavioral: Motivational multicomponent lifestyle intervention + Treatment as usual |
| Control group | Other | Treatment as usual Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Beck Depression Inventory (BDI) scores
Depressive symptoms
Measured: Change from baseline at 3, 12 and 24 months
Change in the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) scores
Mental Wellbeing
Measured: Change from baseline at 3, 12 and 24 months
Change in 15D scores
Health-Related Quality of Life
Measured: Change from baseline at 3, 12 and 24 months
Secondary outcomes (9)
Change in Perceived Stress Scale (PSS-10) scores
Stress
Measured: Change from baseline at 3, 12 and 24 months
Change in Insomnia Severity Index (ISI) scores
Insomnia
Measured: Change from baseline at 3, 12 and 24 months
Change in Numeric Rating Scale for pain
Pain
Measured: Change from baseline at 3, 12 and 24 months
Change in Overall Anxiety Severity and Impairment Scale (OASIS) scores
Anxiety
Measured: Change from baseline at 3, 12 and 24 months
Change in Blood lipid levels
P-Kol, P-KOL-LDL, P-KOL-HDL, P-Trigly
Measured: Change from baseline at 12 and 24 months
Change in weight/body mass index (BMI)
Change in measured weight/BMI
Measured: Change from baseline at 3, 12 and 24 months
Change in waist circumference
Waist (centimeters)
Measured: Change from baseline at 3, 12 and 24 months
Change in Blood pressure (diastolic and systolic)
Blood pressure (diastolic and systolic)
Measured: Change from baseline at 3, 12, and 24 months
Change in Blood glucose levels
P-Glucose and glycated haemoglobin
Measured: Change from baseline at 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start21 Nov 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a 2-arm, randomized controlled clinical trial, in which participants are randomized to the study arms at an individual level. After the baseline data is collected, the study nurse (nurse 1), who conducts the baseline data collection, uses opaque capsules to randomize patients to the study arms.
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland, City of Kuopio, University of Oslo
- Responsible party
- Sponsor
- Investigators
- Pekka Mäntyselkä, Principal investigator, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681767
- Sponsor's protocol ID
- KUH500SH07
- Acronym
- DEPKuopio
- Status last verified
- Sep 2025
- First submitted
- 9 Dec 2022
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Multicomponent Lifestyle Interventions as a Supportive Treatment for Depression in Primary Health Care
- ClinicalTrials.gov ID
- NCT05681767
- Acronym / sponsor ID
- DEPKuopio / KUH500SH07
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- University of Eastern Finland, City of Kuopio, University of Oslo
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jan 2023 (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.
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.
Detailed description
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a 2-arm, randomized controlled clinical trial, in which participants are randomized to the study arms at an individual level. After the baseline data is collected, the study nurse (nurse 1), who conducts the baseline data collection, uses opaque capsules to randomize patients to the study arms.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Motivational multicomponent lifestyle intervention + Treatment as usualMotivational multicomponent lifestyle intervention + treatment as usual |
| Control group | Other | Other: Treatment as usualTreatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- bipolar disorder
- psychosis
- substance abuse
- pregnancy or lactation
- a long-term rehabilitative psychotherapy.
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 |
|---|---|---|
| Motivational multicomponent lifestyle intervention + Treatment as usualStudy 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. | Behavioural | Intervention group |
| Treatment as usualTreatment as usual | Other | Control group |
Primary outcome
Change in Beck Depression Inventory (BDI) scores
Time frame: Change from baseline at 3, 12 and 24 months
Depressive symptoms
Change in the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) scores
Time frame: Change from baseline at 3, 12 and 24 months
Mental Wellbeing
Change in 15D scores
Time frame: Change from baseline at 3, 12 and 24 months
Health-Related Quality of Life
9 secondary outcomes
Change in Perceived Stress Scale (PSS-10) scores
Time frame: Change from baseline at 3, 12 and 24 months
Change in Insomnia Severity Index (ISI) scores
Time frame: Change from baseline at 3, 12 and 24 months
Change in Numeric Rating Scale for pain
Time frame: Change from baseline at 3, 12 and 24 months
Change in Overall Anxiety Severity and Impairment Scale (OASIS) scores
Time frame: Change from baseline at 3, 12 and 24 months
Change in Blood lipid levels
Time frame: Change from baseline at 12 and 24 months
Change in weight/body mass index (BMI)
Time frame: Change from baseline at 3, 12 and 24 months
Change in waist circumference
Time frame: Change from baseline at 3, 12 and 24 months
Change in Blood pressure (diastolic and systolic)
Time frame: Change from baseline at 3, 12, and 24 months
Change in Blood glucose levels
Time frame: Change from baseline at 12 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Ulla Mikkonen contact
Pekka Mäntyselkä principal investigator
University of Eastern Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational multicomponent lifestyle intervention + Treatment as usual and Treatment as usual in people with Depression, run by Kuopio University Hospital at 1 site in Finland.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 19 Sep 2025. 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 Finland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pekka Mäntyselkä (+35850449436, pekka.mantyselka@uef.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Beck Depression Inventory (BDI) scores (time frame: Change from baseline at 3, 12 and 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2025.