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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression
• Intervention / Treatment: Other: Treatment as usual; Behavioral: Motivational multicomponent lifestyle intervention + Treatment as usual

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:

1. What is the effect of the intervention on depressive symptoms at 3- and 12-month follow-ups?
2. What is the effect of the intervention on mental well-being at 3- and 12-month follow-ups?
3. 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?
4. What is the effect of the intervention on health-related quality of life?
5. What is the cost-effectiveness of the intervention?

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pekka Mäntyselkä; Phone Number: +35850449436; Email: pekka.mantyselka@uef.fi
• Study Contact Backup: Name: Ulla Mikkonen; Email: ulla.mikkonen@uef.fi

Study Locations

• Finland
  • Kuopio, Finland
    • Recruiting
    • Kuopio Health Center
    • Contact: Ulla Mikkonen, MD
    • Contact: Pekka Mäntyselkä, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; Treatment as usual	Other: Treatment as usual; Treatment as usual
Experimental: Intervention group; Motivational multicomponent lifestyle intervention + treatment as usual	Behavioral: Motivational multicomponent lifestyle intervention + 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Beck Depression Inventory (BDI) scores	Depressive symptoms	Change from baseline at 3, 12 and 24 months
Change in the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) scores	Mental Wellbeing	Change from baseline at 3, 12 and 24 months
Change in 15D scores	Health-Related Quality of Life	Change from baseline at 3, 12 and 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Perceived Stress Scale (PSS-10) scores	Stress	Change from baseline at 3, 12 and 24 months
Change in Insomnia Severity Index (ISI) scores	Insomnia	Change from baseline at 3, 12 and 24 months
Change in Numeric Rating Scale for pain	Pain	Change from baseline at 3, 12 and 24 months
Change in Overall Anxiety Severity and Impairment Scale (OASIS) scores	Anxiety	Change from baseline at 3, 12 and 24 months
Change in Blood lipid levels	P-Kol, P-KOL-LDL, P-KOL-HDL, P-Trigly	Change from baseline at 12 and 24 months
Change in weight/body mass index (BMI)	Change in measured weight/BMI	Change from baseline at 3, 12 and 24 months
Change in waist circumference	Waist (centimeters)	Change from baseline at 3, 12 and 24 months
Change in Blood pressure (diastolic and systolic)	Blood pressure (diastolic and systolic)	Change from baseline at 3, 12, and 24 months
Change in Blood glucose levels	P-Glucose and glycated haemoglobin	Change from baseline at 12 and 24 months

Collaborators and Investigators

• Sponsor: Kuopio University Hospital
• Collaborators: University of Oslo; University of Eastern Finland; City of Kuopio
• Investigators: Principal Investigator: Pekka Mäntyselkä, University of Eastern Finland

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 9, 2022
• First Submitted That Met QC Criteria: December 28, 2022
• First Posted (Actual): January 12, 2023

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression; Therapeutics
• Other Study ID Numbers: KUH500SH07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No