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

Study Overview
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Brief Summary
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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.

Detailed Description
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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?

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

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Motivational multicomponent lifestyle intervention + Treatment as usual
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Motivational multicomponent lifestyle intervention + treatment as usual | Behavioral: Motivational multicomponent lifestyle intervention + Treatment as usual<br>* 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.<br>|
| Other: Control group<br>Treatment as usual | Other: Treatment as usual<br>* Treatment as usual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |