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

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Motivational multicomponent lifestyle intervention + Treatment as usual
Treatment as usual
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Kuopio Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention group

Control group

Arm Description

Motivational multicomponent lifestyle intervention + treatment as usual

Treatment as usual

Outcomes

Primary Outcome Measures

Change in Beck Depression Inventory (BDI) scores
Depressive symptoms
Change in the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) scores
Mental Wellbeing
Change in 15D scores
Health-Related Quality of Life

Secondary Outcome Measures

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

Full Information

First Posted
December 9, 2022
Last Updated
December 28, 2022
Sponsor
Kuopio University Hospital
Collaborators
University of Eastern Finland, City of Kuopio, University of Oslo
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1. Study Identification

Unique Protocol Identification Number
NCT05681767
Brief Title
Motivational Multicomponent Lifestyle Interventions as a Supportive Treatment for Depression in Primary Health Care
Acronym
DEPKuopio
Official Title
Motivational Multicomponent Lifestyle Interventions as a Supportive Treatment for Depression in Primary Health Care
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuopio University Hospital
Collaborators
University of Eastern Finland, City of Kuopio, University of Oslo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: What is the effect of the intervention on depressive symptoms at 3- and 12-month follow-ups? What is the effect of the intervention on mental well-being at 3- and 12-month follow-ups? 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? What is the effect of the intervention on health-related quality of life? What is the cost-effectiveness of the intervention?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study is a 2-arm, randomized controlled clinical trial, in which participants are randomized to the study arms at an individual level. After the baseline data is collected, the study nurse (nurse 1), who conducts the baseline data collection, uses opaque capsules to randomize patients to the study arms.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Motivational multicomponent lifestyle intervention + treatment as usual
Arm Title
Control group
Arm Type
Other
Arm Description
Treatment as usual
Intervention Type
Behavioral
Intervention Name(s)
Motivational multicomponent lifestyle intervention + Treatment as usual
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
Treatment as usual
Primary Outcome Measure Information:
Title
Change in Beck Depression Inventory (BDI) scores
Description
Depressive symptoms
Time Frame
Change from baseline at 3, 12 and 24 months
Title
Change in the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) scores
Description
Mental Wellbeing
Time Frame
Change from baseline at 3, 12 and 24 months
Title
Change in 15D scores
Description
Health-Related Quality of Life
Time Frame
Change from baseline at 3, 12 and 24 months
Secondary Outcome Measure Information:
Title
Change in Perceived Stress Scale (PSS-10) scores
Description
Stress
Time Frame
Change from baseline at 3, 12 and 24 months
Title
Change in Insomnia Severity Index (ISI) scores
Description
Insomnia
Time Frame
Change from baseline at 3, 12 and 24 months
Title
Change in Numeric Rating Scale for pain
Description
Pain
Time Frame
Change from baseline at 3, 12 and 24 months
Title
Change in Overall Anxiety Severity and Impairment Scale (OASIS) scores
Description
Anxiety
Time Frame
Change from baseline at 3, 12 and 24 months
Title
Change in Blood lipid levels
Description
P-Kol, P-KOL-LDL, P-KOL-HDL, P-Trigly
Time Frame
Change from baseline at 12 and 24 months
Title
Change in weight/body mass index (BMI)
Description
Change in measured weight/BMI
Time Frame
Change from baseline at 3, 12 and 24 months
Title
Change in waist circumference
Description
Waist (centimeters)
Time Frame
Change from baseline at 3, 12 and 24 months
Title
Change in Blood pressure (diastolic and systolic)
Description
Blood pressure (diastolic and systolic)
Time Frame
Change from baseline at 3, 12, and 24 months
Title
Change in Blood glucose levels
Description
P-Glucose and glycated haemoglobin
Time Frame
Change from baseline at 12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pekka Mäntyselkä
Phone
+35850449436
Email
pekka.mantyselka@uef.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Ulla Mikkonen
Email
ulla.mikkonen@uef.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pekka Mäntyselkä
Organizational Affiliation
University of Eastern Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio Health Center
City
Kuopio
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulla Mikkonen, MD
First Name & Middle Initial & Last Name & Degree
Pekka Mäntyselkä, Professor

12. IPD Sharing Statement

Plan to Share IPD
No

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

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