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

Depression Clinical Trial

— DEPKuopio  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05681767
• Other study ID #: KUH500SH07
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2022
• Source: Kuopio University Hospital
• Contact: Pekka Mäntyselkä
• Phone: +35850449436
• Email: pekka.mantyselka[@]uef.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Other:
• Treatment as usual
Treatment as usual

Locations

Country	Name	City	State
Finland	Kuopio Health Center	Kuopio

Sponsors (4)

Lead Sponsor	Collaborator
Kuopio University Hospital	City of Kuopio, University of Eastern Finland, University of Oslo

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Beck Depression Inventory (BDI) scores	Depressive symptoms	Change from baseline at 3, 12 and 24 months
Primary	Change in the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) scores	Mental Wellbeing	Change from baseline at 3, 12 and 24 months
Primary	Change in 15D scores	Health-Related Quality of Life	Change from baseline at 3, 12 and 24 months
Secondary	Change in Perceived Stress Scale (PSS-10) scores	Stress	Change from baseline at 3, 12 and 24 months
Secondary	Change in Insomnia Severity Index (ISI) scores	Insomnia	Change from baseline at 3, 12 and 24 months
Secondary	Change in Numeric Rating Scale for pain	Pain	Change from baseline at 3, 12 and 24 months
Secondary	Change in Overall Anxiety Severity and Impairment Scale (OASIS) scores	Anxiety	Change from baseline at 3, 12 and 24 months
Secondary	Change in Blood lipid levels	P-Kol, P-KOL-LDL, P-KOL-HDL, P-Trigly	Change from baseline at 12 and 24 months
Secondary	Change in weight/body mass index (BMI)	Change in measured weight/BMI	Change from baseline at 3, 12 and 24 months
Secondary	Change in waist circumference	Waist (centimeters)	Change from baseline at 3, 12 and 24 months
Secondary	Change in Blood pressure (diastolic and systolic)	Blood pressure (diastolic and systolic)	Change from baseline at 3, 12, and 24 months
Secondary	Change in Blood glucose levels	P-Glucose and glycated haemoglobin	Change from baseline at 12 and 24 months