Effectiveness and Cost-effectiveness of a Lifestyle Modification Program in the Prevention and Treatment of Subclinical, Mild and Moderate Depression in Primary Care: A Randomized Clinical Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 试验地点
- 2
- 主要终点
- Beck II Self-Applied Depression Inventory (BDI-II)
研究概览
简要总结
Introduction:
Major depression is a highly prevalent pathology that is currently the second most common cause of disease-induced disability in our society. The onset and continuation of depression may be related to a wide variety of biological and psychosocial factors, many of which are linked to different lifestyle aspects. Therefore, health systems must design and implement health promotion and lifestyle modification programs, taking into account personal factors and facilitators. The main objective of this work is to analyze the utility and cost-effectiveness of an adjunctive treatment program for subclinical, mild or moderate depression in Primary Care patients, based on healthier lifestyle recommendations. Secondary objectives include the analysis of the effectiveness of the intervention in comorbid chronic pathology and the measurement of the influence of personal factors on lifestyle modification.
Methods and analysis:
A randomized, multicenter pragmatic clinical trial with 3 parallel groups consisting of primary healthcare patients suffering from subclinical, mild or moderate depression. The following interventions will be used: 1. Usual antidepressant treatment with psychological advice and/or psychotropic drugs prescribed by the General Practitioner (treatment-as-usual, TAU). 2. TAU + Lifestyle Modification Program (LMP). A program to be imparted in 6 weekly 90-minute group sessions, intended to improve the following aspects: behavioral activation + daily physical activity + adherence to the Mediterranean diet pattern + sleep hygiene + careful exposure to sunlight. 3. TAU + LMP + ICTs: healthy lifestyle recommendations (TAU+LMP intervention) + monitoring using ICTs (a wearable smartwatch). The primary outcome will be the depressive symptomatology and the secondary outcomes will be the quality of life, the use of health and social resources, personal variables related to program adherence (patient activation in their own health, self-efficacy, sense of coherence, health literacy and procrastination) and chronic comorbid pathology. Data will be collected before and after the intervention, with 6- and 12-month follow-ups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals over the age of
- •Both sexes.
- •Having a duration of depression symptoms of at least 2 months.
- •Who perfectly understand written and spoken Spanish.
- •Who have provided their informed consent.
排除标准
- •Suffering from another disease that affects the central nervous system (organic brain pathology or having suffered a traumatic brain injury of any severity, dementia).
- •Having another psychiatric diagnosis or serious psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, eating disorders) with the exception of anxious pathology or personality disorders (collected through a medical history and from the Mini-International Neuropsychiatric Interview (MINI) (Ferrando, Bobes, & Gibert, 2000)).
- •Presence of a serious or uncontrolled medical, infectious or degenerative illness that may interfere with the affective symptoms.
- •Presence of delirium or hallucinations, risk of suicide, pregnancy or lactation.
- •Patients who have participated in another clinical trial over the past 6 months or who are currently in psychotherapy.
- •Who practice mindfulness, yoga, meditation or similar practices over the past 6 months, engaging in formal practice at least once a week.
- •Presence of any medical, psychological or social problem that could seriously interfere with the patient's participation in the study.
结局指标
主要结局
Beck II Self-Applied Depression Inventory (BDI-II)
时间窗: Change from baseline, immediately after the intervention and at six and 12-month follow-up.
The primary outcome will be measured using the BDI-II (Beck et al., 1996). This is a self-report inventory for measuring the severity of depression, consisting of 21 multiple-choice questions with each answer being scored on a scale ranged from 0 to 3. It was translated and validated into Spanish with a reliability of .89 (Sanz et al., 2005). The standardized cutoffs are: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.
次要结局
- Comorbidity with chronic diseases(Change from baseline, immediately after the intervention and at six and 12-month follow-up.)
- Mediterranean Diet Adherence Screener (MEDAS)(Change from baseline, immediately after the intervention and at six and 12-month follow-up.)
- Social support questionnaire (MOS)(Change from baseline, immediately after the intervention and at six and 12-month follow-up.)
- Sense of coherence questionnaire of Antonovsky(Change from baseline, immediately after the intervention and at six and 12-month follow-up.)
- International Neuropsychiatric Interview (MINI)(Baseline)
- European Quality of Life-5 Dimensions questionnaire (EQ-5D)(Change from baseline, immediately after the intervention and at six and 12-month follow-up.)
- Physical activity questionnaire (IPAQ-SF)(Change from baseline, immediately after the intervention and at six and 12-month follow-up.)
- Health Literacy Europe questionnaire (HLS-EUQ16)(Change from baseline, immediately after the intervention and at six and 12-month follow-up.)
- Irrational Procrastination Scale (IPS)(Change from baseline, immediately after the intervention and at six and 12-month follow-up.)
- Pittsburgh Sleep Quality Index (PSQI)(Change from baseline, immediately after the intervention and at six and 12-month follow-up.)
- The Self-Efficacy Scale(Change from baseline, immediately after the intervention and at six and 12-month follow-up.)
- Client Service Receipt Inventory (CSRI)(Change from baseline, immediately after the intervention and at six and 12-month follow-up.)
- Patient Activation Questionnaire (PAM) in relation to the management of their health(Change from baseline, immediately after the intervention and at six and 12-month follow-up.)
研究者
Bárbara Oliván-Blázquez
Professor University of Zaragoza
Instituto de Investigación Sanitaria Aragón