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| Name | Class |
|---|---|
| University of Eastern Finland | OTHER |
| City of Kuopio | OTHER_GOV |
| University of Oslo | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Motivational multicomponent lifestyle intervention + treatment as usual |
|
| Control group | Other | Treatment as usual |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational multicomponent lifestyle intervention + Treatment as usual | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Beck Depression Inventory (BDI) scores | Depressive symptoms | Change from baseline at 3, 12 and 24 months |
| Change in the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) scores | Mental Wellbeing | Change from baseline at 3, 12 and 24 months |
| Change in 15D scores | Health-Related Quality of Life | Change from baseline at 3, 12 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Perceived Stress Scale (PSS-10) scores | Stress | Change from baseline at 3, 12 and 24 months |
| Change in Insomnia Severity Index (ISI) scores | Insomnia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pekka Mäntyselkä | Contact | +35850449436 | pekka.mantyselka@uef.fi | |
| Ulla Mikkonen | Contact | ulla.mikkonen@uef.fi |
| Name | Affiliation | Role |
|---|---|---|
| Pekka Mäntyselkä | University of Eastern Finland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuopio Health Center | Recruiting | Kuopio | Finland |
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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.
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| Treatment as usual | Other | Treatment as usual |
|
| Change from baseline at 3, 12 and 24 months |
| Change in Numeric Rating Scale for pain | Pain | Change from baseline at 3, 12 and 24 months |
| Change in Overall Anxiety Severity and Impairment Scale (OASIS) scores | Anxiety | Change from baseline at 3, 12 and 24 months |
| Change in Blood lipid levels | P-Kol, P-KOL-LDL, P-KOL-HDL, P-Trigly | Change from baseline at 12 and 24 months |
| Change in weight/body mass index (BMI) | Change in measured weight/BMI | Change from baseline at 3, 12 and 24 months |
| Change in waist circumference | Waist (centimeters) | Change from baseline at 3, 12 and 24 months |
| Change in Blood pressure (diastolic and systolic) | Blood pressure (diastolic and systolic) | Change from baseline at 3, 12, and 24 months |
| Change in Blood glucose levels | P-Glucose and glycated haemoglobin | Change from baseline at 12 and 24 months |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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