Motivational Multicomponent Lifestyle Interventions as a Supportive Treatment for Depression in Primary Health Care
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Motivational multicomponent lifestyle intervention + Treatment as usual, Treatment as usual.
- Кому может быть актуально
- Состояния в реестре: Depression. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Финляндия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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.
Подробное описание
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?
Вмешательства
- Поведенческое 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, - Другое Treatment as usual
Treatment as usual
Первичные конечные точки
- Change in Beck Depression Inventory (BDI) scores [Срок оценки: Change from baseline at 3, 12 and 24 months]
- Change in the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) scores [Срок оценки: Change from baseline at 3, 12 and 24 months]
- Change in 15D scores [Срок оценки: Change from baseline at 3, 12 and 24 months]
Вторичные конечные точки (9)
- Change in Perceived Stress Scale (PSS-10) scores [Срок оценки: Change from baseline at 3, 12 and 24 months]
- Change in Insomnia Severity Index (ISI) scores [Срок оценки: Change from baseline at 3, 12 and 24 months]
- Change in Numeric Rating Scale for pain [Срок оценки: Change from baseline at 3, 12 and 24 months]
- Change in Overall Anxiety Severity and Impairment Scale (OASIS) scores [Срок оценки: Change from baseline at 3, 12 and 24 months]
- Change in Blood lipid levels [Срок оценки: Change from baseline at 12 and 24 months]
- Change in weight/body mass index (BMI) [Срок оценки: Change from baseline at 3, 12 and 24 months]
- Change in waist circumference [Срок оценки: Change from baseline at 3, 12 and 24 months]
- Change in Blood pressure (diastolic and systolic) [Срок оценки: Change from baseline at 3, 12, and 24 months]
- Change in Blood glucose levels [Срок оценки: Change from baseline at 12 and 24 months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- bipolar disorder
- psychosis
- substance abuse
- pregnancy or lactation
- a long-term rehabilitative psychotherapy.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Финляндия · 1 центр
- Kuopio Health Center — Kuopio
Идентификаторы
NCT: NCT05681767 · KUH500SH07