An interventional study of Motivational multicomponent lifestyle intervention + Treatment as usual and Treatment as usual in Depression, sponsored by Kuopio University Hospital. Recruiting at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Kuopio University Hospital · Not applicable, Interventional, and Treatment
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.
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:
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 210 is above the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →Kuopio University Hospital is the lead sponsor of 135 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Motivational multicomponent lifestyle intervention + treatment as usual
Behavioral: Motivational multicomponent lifestyle intervention + Treatment as usual
Treatment as usual
Other: Treatment as usual
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
Change in Beck Depression Inventory (BDI) scores
Depressive symptoms
Time frame: Change from baseline at 3, 12 and 24 months
Change in the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) scores
Mental Wellbeing
Time frame: Change from baseline at 3, 12 and 24 months
Change in 15D scores
Health-Related Quality of Life
Time frame: Change from baseline at 3, 12 and 24 months
Change in Perceived Stress Scale (PSS-10) scores
Stress
Time frame: Change from baseline at 3, 12 and 24 months
Change in Insomnia Severity Index (ISI) scores
Insomnia
Time frame: Change from baseline at 3, 12 and 24 months
Change in Numeric Rating Scale for pain
Pain
Time frame: Change from baseline at 3, 12 and 24 months
Change in Overall Anxiety Severity and Impairment Scale (OASIS) scores
Anxiety
Time frame: Change from baseline at 3, 12 and 24 months
Change in Blood lipid levels
P-Kol, P-KOL-LDL, P-KOL-HDL, P-Trigly
Time frame: Change from baseline at 12 and 24 months
Change in weight/body mass index (BMI)
Change in measured weight/BMI
Time frame: Change from baseline at 3, 12 and 24 months
Change in waist circumference
Waist (centimeters)
Time frame: Change from baseline at 3, 12 and 24 months
Change in Blood pressure (diastolic and systolic)
Blood pressure (diastolic and systolic)
Time frame: Change from baseline at 3, 12, and 24 months
Change in Blood glucose levels
P-Glucose and glycated haemoglobin
Time frame: Change from baseline at 12 and 24 months
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2022 (actual). Primary completion is estimated for Dec 2025, 37 months after the start.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 37 months is above that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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