Well-being Online: Internet-based Self-administered Intervention to Reduce Anxiety and Depression Symptomatology: Randomized Clinical Trial in 7 Countries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 9
- 主要终点
- Decrease in the score of the General Anxiety Disorder with 7-items (GAD-7) scale
研究概览
简要总结
This study evaluates the effectiveness of an online Multi-component psychological intervention, that is focused on providing self-support to the population of 5 Latin American countries and 2 European Countries. The objectives of the intervention are: 1) To reduce the symptoms of anxiety and depression in the adult population, 2) To increase the levels of subjective well-being.
详细描述
Anxiety and depression at clinically significant levels are associated with suicidal thoughts and behaviors. Furthermore, it is associated with the health-disease process in two ways: 1) variables that influence behavior, hindering people's healthy habits and promoting the development of unhealthy behaviors; 2) anxiety and depression affect the psycho physiological activation of people, which affects their immune system.
Considering the damage that can occur by not addressing incipient problems of anxiety and depression, it is important to develop interventions with preventive purposes. Thus, the online modality of the intervention presented in this project can benefit a significant number of people in Mexico, Ecuador, Chile, Brazil, Peru, the Netherlands and Spain. The online modality of psychological interventions is a viable treatment alternative, especially for those people who do not have any psychological treatment within their reach.
The participants will be measured at pre, middle treatment, post assessment and two follow ups of 3 and 6 months. The self-report measures will include the following Psychometrics:
- General Anxiety Disorder with 7-items (GAD-7)
- Center for Epidemiologic Studies Depression Scale" in its revised version (CESD-R).
- Perceived Stress Scale (PSS-10)
- Pittsburgh Sleep Quality scale (PSQI)
- Action Acceptance Questionnaire II (AAQ-II)
- The Satisfaction with Life scale
- The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
- Perceived Deficits Questionnaire (PDQ-5)
- The Positive and Negative Affect Schedule (PANAS)
- Opinion on the treatment.
- System usability scale.
- Client Satisfaction Questionnaire (CSQ-8S)
- The Telehealth Usability Questionnaire (TUQ)
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
- Single (Participant)
盲法说明
The patients are not aware that there are another experimental group and a control group. The conditions of the study are only known by the researcher and the Research Ethics Committee of the Universidad Autónoma de Ciudad Juárez.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •Completion of 100% of the basal evaluation through the form
- •Residence in one of the countries participating in the study
- •Fluency/ proficiency in Spanish (Mexico, Ecuador, Chile, Peru and Spain), Dutch or English (Netherlands) or Portuguese (Brazil), depending on the country.
排除标准
- •Participants with severe symptoms of anxiety and/or depression, or they report a diagnosis of a depression and/or an anxiety disorder.
- •Participants who self-report having another diagnosed psychiatric comorbidity: personality disorder, psychotic disorder, bipolar disorder, Attention-Deficit/Hyperactivity Disorder, or others.
- •Participants taking medication for symptoms of depression and/or anxiety
结局指标
主要结局
Decrease in the score of the General Anxiety Disorder with 7-items (GAD-7) scale
时间窗: 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules
Is a short scale with items that measure the severity of generalized anxiety disorder symptoms. Responses are based on symptoms perceived during the past week. The questions of this scale are answered in Likert format with 0-3, where the maximum total score is 21. A score between 0 and 4 points indicates that anxiety is not perceived, and a score between 15 and 21 is an indicator of perceived severe anxiety.It is expected a statistically significant decrease (P \< 0.05) in anxiety symptoms.
Increase in Mental Psychological Well-being, the Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
时间窗: Time Frame: 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules
It consists of 14 items, including hedonic (i.e. affects, life satisfaction) and eudaimonic (i.e. positive relationships, psychological functioning) items, which together measure mental well-being. Each item is responded in a Likert scale (i.e. 1 = none of the time to 5 = all of the time) and the total score ranges from 14 to 70. The higher the score, the higher the mental well-being
Decrease in the scores of the Center for Epidemiologic Studies Depression (CESD-R) scale
时间窗: 1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules
Center for Epidemiologic Studies Depression (CES-D) is a structured self-report scale for evaluation depression symptoms. This scale assesses the number of depression symptoms within 2 weeks. The scale consists 20 items and contains 4-point score responses (0 to 3) as the following; rarely or none of the time (less than 1 day); some of a little of the time (1-2 days); occasionally or moderate amount of time (3-4 days) and most or all of the time (5-7 days). The total possible range of scores is from 0 to 60 where \^16 is the cut-off point for this scale, and higher scores indicate more symptoms of depression. It is expected a statistically significant decrease (P \< 0.05) in depression symptoms.
次要结局
- Decrease in the score of The Pittsburgh Sleep Quality Index(1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules)
- Decrease in The Perceived Stress Scale (PSS-10)(1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules)
- Decrease in the Action Acceptance Questionnaire II (AAQ-II)(1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules)
- Decrease negative affect in the Positive and Negative Affect Schedule (PANAS)(1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules)
- Increase positive affect in the Positive and Negative Affect Schedule (PANAS)(1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules)
- Increase in The Satisfaction with Life scale(1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules)
- Decrease in the Perceived Deficits Questionnaire or PDQ-5(1 to 1.5 months, depending on the development of the patient and the completion of the 10 modules)