Clinical trial NCT05681767: Motivational Multicomponent Lifestyle Interventions as a Supportive Treatment for Depression in Primary Health Care
Official title: Motivational Multicomponent Lifestyle Interventions as a Supportive Treatment for Depression in Primary Health Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
name: City of Kuopio
name: University of Oslo
First posted: 2023-01-12
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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?

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.

Primary outcomes:
measure: Change in Beck Depression Inventory (BDI) scores
timeFrame: Change from baseline at 3, 12 and 24 months
measure: Change in the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) scores
timeFrame: Change from baseline at 3, 12 and 24 months
measure: Change in 15D scores
timeFrame: Change from baseline at 3, 12 and 24 months
Secondary outcomes:
measure: Change in Perceived Stress Scale (PSS-10) scores
timeFrame: Change from baseline at 3, 12 and 24 months
measure: Change in Insomnia Severity Index (ISI) scores
timeFrame: Change from baseline at 3, 12 and 24 months
measure: Change in Numeric Rating Scale for pain
timeFrame: Change from baseline at 3, 12 and 24 months
measure: Change in Overall Anxiety Severity and Impairment Scale (OASIS) scores
timeFrame: Change from baseline at 3, 12 and 24 months
measure: Change in Blood lipid levels
timeFrame: Change from baseline at 12 and 24 months
measure: Change in weight/body mass index (BMI)
timeFrame: Change from baseline at 3, 12 and 24 months
measure: Change in waist circumference
timeFrame: Change from baseline at 3, 12 and 24 months
measure: Change in Blood pressure (diastolic and systolic)
timeFrame: Change from baseline at 3, 12, and 24 months
measure: Change in Blood glucose levels
timeFrame: Change from baseline at 12 and 24 months
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio Health Center
Study officials:
affiliation: University of Eastern Finland
name: Pekka Mäntyselkä
role: PRINCIPAL_INVESTIGATOR
References: