Skip to main content
Clinical Trials/NCT05681767
NCT05681767
Recruiting
N/A

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

Kuopio University Hospital1 site in 1 country210 target enrollmentNovember 21, 2022
ConditionsDepression

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depression
Sponsor
Kuopio University Hospital
Enrollment
210
Locations
1
Primary Endpoint
Change in Beck Depression Inventory (BDI) scores
Status
Recruiting
Last Updated
7 months ago

Overview

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?

Registry
clinicaltrials.gov
Start Date
November 21, 2022
End Date
December 31, 2026
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kuopio University Hospital
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Change in Beck Depression Inventory (BDI) scores

Time Frame: Change from baseline at 3, 12 and 24 months

Depressive symptoms

Change in the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) scores

Time Frame: Change from baseline at 3, 12 and 24 months

Mental Wellbeing

Change in 15D scores

Time Frame: Change from baseline at 3, 12 and 24 months

Health-Related Quality of Life

Secondary Outcomes

  • Change in Blood lipid levels(Change from baseline at 12 and 24 months)
  • Change in waist circumference(Change from baseline at 3, 12 and 24 months)
  • Change in Perceived Stress Scale (PSS-10) scores(Change from baseline at 3, 12 and 24 months)
  • Change in weight/body mass index (BMI)(Change from baseline at 3, 12 and 24 months)
  • Change in Blood pressure (diastolic and systolic)(Change from baseline at 3, 12, and 24 months)
  • Change in Insomnia Severity Index (ISI) scores(Change from baseline at 3, 12 and 24 months)
  • Change in Numeric Rating Scale for pain(Change from baseline at 3, 12 and 24 months)
  • Change in Overall Anxiety Severity and Impairment Scale (OASIS) scores(Change from baseline at 3, 12 and 24 months)
  • Change in Blood glucose levels(Change from baseline at 12 and 24 months)

Study Sites (1)

Loading locations...

Similar Trials