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

• Sponsor: Kuopio University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05681767
• Collaborator: University of Eastern Finland (Other), City of Kuopio (Other), University of Oslo (Other)
• Enrollment: 210
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 49.3
• Patients Per Site Per Month: 4.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Behavioral: Motivational multicomponent lifestyle intervention + Treatment as usual; Other: Treatment as usual	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 210 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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)
• Primary Purpose: Treatment
• Official Title: Motivational Multicomponent Lifestyle Interventions as a Supportive Treatment for Depression in Primary Health Care
• Actual Study Start Date: Nov 21, 2022
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group Motivational multicomponent lifestyle intervention + treatment as usual	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: Control group Treatment as usual	Other: Treatment as usual; Treatment as usual

Outcome Measures

Primary Outcome Measures

1. Change in Beck Depression Inventory (BDI) scores [Change from baseline at 3, 12 and 24 months]

   Depressive symptoms

2. Change in the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) scores [Change from baseline at 3, 12 and 24 months]

   Mental Wellbeing

3. Change in 15D scores [Change from baseline at 3, 12 and 24 months]

   Health-Related Quality of Life

Secondary Outcome Measures

1. Change in Perceived Stress Scale (PSS-10) scores [Change from baseline at 3, 12 and 24 months]

   Stress

2. Change in Insomnia Severity Index (ISI) scores [Change from baseline at 3, 12 and 24 months]

   Insomnia

3. Change in Numeric Rating Scale for pain [Change from baseline at 3, 12 and 24 months]

   Pain

4. Change in Overall Anxiety Severity and Impairment Scale (OASIS) scores [Change from baseline at 3, 12 and 24 months]

   Anxiety

5. Change in Blood lipid levels [Change from baseline at 12 and 24 months]

   P-Kol, P-KOL-LDL, P-KOL-HDL, P-Trigly

6. Change in weight/body mass index (BMI) [Change from baseline at 3, 12 and 24 months]

   Change in measured weight/BMI

7. Change in waist circumference [Change from baseline at 3, 12 and 24 months]

   Waist (centimeters)

8. Change in Blood pressure (diastolic and systolic) [Change from baseline at 3, 12, and 24 months]

   Blood pressure (diastolic and systolic)

9. Change in Blood glucose levels [Change from baseline at 12 and 24 months]

   P-Glucose and glycated haemoglobin

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kuopio Health Center	Kuopio		Finland

Sponsors and Collaborators

• Kuopio University Hospital
• University of Eastern Finland
• City of Kuopio
• University of Oslo

Investigators

• Principal Investigator: Pekka Mäntyselkä, University of Eastern Finland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kuopio University Hospital
• ClinicalTrials.gov Identifier: NCT05681767
• Other Study ID Numbers: KUH500SH07
• First Posted: Jan 12, 2023
• Last Update Posted: Jan 12, 2023
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depression; Depressive Disorder

Study Results

No Results Posted as of Jan 12, 2023