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

Not Applicable

Recruiting

• Conditions: Depression
• Interventions: Behavioral: Motivational multicomponent lifestyle intervention + Treatment as usual; Other: Treatment as usual

• Registration Number: NCT05681767
• Lead Sponsor: Kuopio University Hospital

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?

Study Timeline

• Status Verified: 2022-11
• Study Start: 2022-11-21
• Study First Submitted: 2022-12-09
• Study First Submitted QC: 2022-12-28
• Last Update Submitted: 2022-12-28
• Study First Posted: 2023-01-12
• Last Update Posted: 2023-01-12
• Primary Completion: 2024-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Motivational multicomponent lifestyle intervention + Treatment as usual	Motivational multicomponent lifestyle intervention + treatment as usual
Control group	Treatment as usual	Treatment as usual

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kuopio Health Center; 🇫🇮 Kuopio, Finland