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

NCT ID: NCT05681767

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-21
• Study Completion Date: 2026-12-31

Brief 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.

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?

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

Motivational multicomponent lifestyle intervention + treatment as usual

Group Type: EXPERIMENTAL

Motivational multicomponent lifestyle intervention + Treatment as usual

Intervention Type: 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.

Control group

Treatment as usual

Group Type: OTHER

Treatment as usual

Intervention Type: OTHER

Treatment as usual

Interventions

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.

Intervention Type: BEHAVIORAL

Treatment as usual

Treatment as usual

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Eastern Finland

OTHER

Sponsor Role: collaborator

City of Kuopio

OTHER_GOV

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: collaborator

Kuopio University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pekka Mäntyselkä

Role: PRINCIPAL_INVESTIGATOR

University of Eastern Finland

Locations

Kuopio Health Center

Kuopio, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Pekka Mäntyselkä

Role: CONTACT

pekka.mantyselka@uef.fi

+35850449436

Ulla Mikkonen

Role: CONTACT

ulla.mikkonen@uef.fi

Facility Contacts

Ulla Mikkonen, MD

Role: primary

Pekka Mäntyselkä, Professor

Role: backup

Other Identifiers

KUH500SH07

Identifier Type: -

Identifier Source: org_study_id