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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05681767
Other study ID # KUH500SH07
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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