Depression
Conditions
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?
Interventions
BEHAVIORALMotivational 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.
OTHERTreatment as usual
Treatment as usual
Sponsors
University of Eastern Finland
City of Kuopio
University of Oslo
Kuopio University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Beck Depression Inventory (BDI) scores | Change from baseline at 3, 12 and 24 months | Depressive symptoms |
| Change in the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) scores | Change from baseline at 3, 12 and 24 months | Mental Wellbeing |
| Change in 15D scores | Change from baseline at 3, 12 and 24 months | Health-Related Quality of Life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Overall Anxiety Severity and Impairment Scale (OASIS) scores | Change from baseline at 3, 12 and 24 months | Anxiety |
| Change in Blood lipid levels | Change from baseline at 12 and 24 months | P-Kol, P-KOL-LDL, P-KOL-HDL, P-Trigly |
| Change in weight/body mass index (BMI) | Change from baseline at 3, 12 and 24 months | Change in measured weight/BMI |
| Change in Perceived Stress Scale (PSS-10) scores | Change from baseline at 3, 12 and 24 months | Stress |
| Change in Blood pressure (diastolic and systolic) | Change from baseline at 3, 12, and 24 months | Blood pressure (diastolic and systolic) |
| Change in Blood glucose levels | Change from baseline at 12 and 24 months | P-Glucose and glycated haemoglobin |
| Change in waist circumference | Change from baseline at 3, 12 and 24 months | Waist (centimeters) |
| Change in Insomnia Severity Index (ISI) scores | Change from baseline at 3, 12 and 24 months | Insomnia |
| Change in Numeric Rating Scale for pain | Change from baseline at 3, 12 and 24 months | Pain |
Countries
Finland
Contacts
Primary ContactPekka Mäntyselkä
Backup ContactUlla Mikkonen
Outcome results
None listed