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

Kuopio University Hospital

Status: Enrolling

Conditions: Depression

Treatments: Other: Treatment as usual; Behavioral: Motivational multicomponent lifestyle intervention + Treatment as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT05681767

KUH500SH07

Details and patient eligibility

About

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.

Full 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?

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 2 patient groups

Intervention group

Experimental group

Description:

Motivational multicomponent lifestyle intervention + treatment as usual

Treatment:

Behavioral: Motivational multicomponent lifestyle intervention + Treatment as usual

Control group

Other group

Description:

Treatment as usual

Treatment:

Other: Treatment as usual