Implementation Study of an Interactive Technological Intervention to Improve Mental Health Symptoms in Primary Health Care Users
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12,400
- 试验地点
- 1
- 主要终点
- Proportion of participants who have 'recovered' from depressive symptoms (PHQ-9 < 10)
研究概览
简要总结
This study aims to implement and evaluate a technological intervention called CONEMO to treat depressive symptoms, anxiety, and insomnia in adults who use primary health care services. The effectiveness of this intervention has already been proven in previous research, specifically for depressive symptoms. Implementation will occur in 28 basic health units in the municipalities of Indiatuba and Jaguariúna in the interior of São Paulo.
All eligible residents of the cities will be invited to participate.
详细描述
A type III hybrid implementation and effectiveness study, with a mixed-method explanatory sequential design consisting of two distinct stages: the first quantitative, followed by qualitative. The method is indicated when the researcher wishes to use qualitative data to help interpret and explain the initial quantitative findings and deepen them. The elements of both methods are analyzed separately and then merged, looking for convergences, divergences, contradictions, or relationships between the two databases.
The qualitative data will help to interpret, explain and deepen the quantitative findings. The guidelines of the Consolidated Criteria for Reporting Qualitative Research (COREQ) will be followed, a 32-item instrument that guides the conduct of the interview and analysis of qualitative data, also validated in Portuguese in Brazil.
Study site The study will be carried out in 28 Basic Health Units (UBS) in two municipalities in the interior of São Paulo, Indaiatuba and Jaguariúna, located approximately 100 km from the capital São Paulo, in the state of São Paulo, Brazil.
Study population - stakeholder groups Patients/service users - user category Our study population will be made up of adult individuals (18 years or older) who live in the municipality of Indaiatuba or Jaguariúna and attend the UBS and who show significant symptoms of depression, anxiety or insomnia.
Health professionals, service managers and local managers - professional categories Adults (18 years or older) from the groups of interest will also participate in the study: health professionals from the UBS in the municipalities of Jaguariúna and Indaiatuba, service managers, health department managers, or primary care and mental health coordinators. We consider these individuals to be the main stakeholders, in addition to the users and main participants in the research, in the unfolding of the CONEMO intervention implementation study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Look for consultation in basic health units due to Major Depressive Disorder, Insomnia and/or Generalized Anxiety Disorder, or who receive home visits for the same reason.
- •Score >= 10 on the PHQ-9 Scale for Depression; and/or >= 11 on the IGI Scale for Insomnia; and/or >= 10 on the GAD-7 Scale for Anxiety.
- •Be able to read the app's instructions via a tablet or smartphone screen.
排除标准
- •Individuals considered severe on the Suicide Risk Assessment Protocol-SRAP (suicidal imminence)
研究组 & 干预措施
CONEMO
CONEMO is a low-intensity psychoeducational program which is made available to users via smartphones compatible with Android or iOS systems. At the same time, the designed healthcare professional use a tablet to monitor user adherence to the intervention. CONEMO comprise seven weekly modules, totally self-guides.
干预措施: CONEMO App (Device)
结局指标
主要结局
Proportion of participants who have 'recovered' from depressive symptoms (PHQ-9 < 10)
时间窗: 3 months
Patient Health Questionnaire-9 (PHQ-9) is a questionnaire to access the severity of participants' depressive symptoms. The PHQ-9 score varies according to the severity of the symptoms and is classified as follows: no depression (0 to 4), mild symptoms (5 to 9), moderate symptoms (10 to 14), moderately severe symptoms (15 to 19) and severe symptoms (20 to 27). A cut-off point of 10 is suggested to indicate the presence of significant depressive symptoms.
Proportion of participants who have 'recovered' from anxiety (GAD-7< 10)
时间窗: 3 months
General Anxiety Disorder-7 (GAD-7) scale, which measures common symptoms associated with generalized anxiety disorder in the last two weeks. Each of the scale's seven items ranges from 0 ('not at all') to 3 ('almost every day'), resulting in a total score ranging from 0 to 21. A suggested cut-off point of more than 10 points indicates the presence of anxiety.
Proportion of participants who have 'recovered' from insomnia (IGI<8)
时间窗: 3 months
Insomnia Severity Index (IGI) is a retrospective instrument that assesses the last month and is made up of seven items that explore various aspects of sleep, including difficulties initiating or maintaining sleep, early morning awakening, satisfaction with sleep, daytime impairment, perception of sleep problems by other people, and concern about sleep problems. Respondents use a Likert scale ranging from 0 (no severity) to 4 (high severity), resulting in a total score ranging from 0 to 28. This score is classified as follows: no insomnia (0 to 7), mild insomnia (8 to 14), moderate insomnia (15 to 21) and severe insomnia (22 to 28
次要结局
- Social Support Assessment:(3 months and 6 months)
- Quality of Life(3 months and 6 months)
- Daily Activity Level:(3 months and 6 months)