Motivational Multicomponent Lifestyle Interventions as a Supportive Treatment for Depression in Primary Health Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Motivational multicomponent lifestyle intervention + Treatment as usual, Treatment as usual.
- Who it may be relevant to
- Registry conditions: Depression. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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?
Interventions
- 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, - Other Treatment as usual
Treatment as usual
Primary outcome measures
- Change in Beck Depression Inventory (BDI) scores [Time frame: Change from baseline at 3, 12 and 24 months]
- Change in the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) scores [Time frame: Change from baseline at 3, 12 and 24 months]
- Change in 15D scores [Time frame: Change from baseline at 3, 12 and 24 months]
Secondary outcome measures (9)
- Change in Perceived Stress Scale (PSS-10) scores [Time frame: Change from baseline at 3, 12 and 24 months]
- Change in Insomnia Severity Index (ISI) scores [Time frame: Change from baseline at 3, 12 and 24 months]
- Change in Numeric Rating Scale for pain [Time frame: Change from baseline at 3, 12 and 24 months]
- Change in Overall Anxiety Severity and Impairment Scale (OASIS) scores [Time frame: Change from baseline at 3, 12 and 24 months]
- Change in Blood lipid levels [Time frame: Change from baseline at 12 and 24 months]
- Change in weight/body mass index (BMI) [Time frame: Change from baseline at 3, 12 and 24 months]
- Change in waist circumference [Time frame: Change from baseline at 3, 12 and 24 months]
- Change in Blood pressure (diastolic and systolic) [Time frame: Change from baseline at 3, 12, and 24 months]
- Change in Blood glucose levels [Time frame: Change from baseline at 12 and 24 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Finland · 1 center
- Kuopio Health Center — Kuopio
Identifiers
NCT: NCT05681767 · KUH500SH07