Implementation of Internet-based Psychotherapy for Symptoms of Depression, Insomnia and Anxiety in Primary Care in the Cities of Indaiatuba and Jaguariuna
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 268
- 试验地点
- 2
- 主要终点
- PHQ-9 - Patient Health Questionnaire-9
研究概览
简要总结
The main objective of this study is to evaluate the effectiveness and success of implementing internet-based cognitive behavioral psychotherapy (iCBT) guided by a therapist for symptoms of depression, insomnia and anxiety in individuals who did not respond to an automated intervention in primary care in the cities of Indaiatuba and Jaguariúna. Method: This is a pragmatic, prospective, randomized, two-arm, parallel-group, controlled clinical trial, comparing a therapist-guided Internet-based cognitive behavioral therapy (iCBT) treatment associated with usual care versus usual care alone (UC) for symptoms of depression, insomnia and anxiety in adults who attend primary care in the cities of Indaiatuba and Jaguariúna and who did not respond to a first phase of treatment with automated iCBT (not guided by a therapist) focused on these groups of symptoms. The results will be accessed during treatment, in the immediate post-treatment (after two weeks of completing treatment) and at 3 and 6 month follow-up.
详细描述
Hypotheses:
Guided iCBT will produce an additive effect of significant reduction in symptoms of depression, insomnia, and anxiety compared to treatment as usual.
Design Plan:
Study type Experiment - A researcher randomly assigns treatments to study subjects, this includes field or lab experiments. This is also known as an intervention experiment and includes randomized controlled trials.
Blinding Personnel who analyze the data collected from the study are not aware of the treatment applied to any given group.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants included in the first phase of the study;
- •Depression complaints with significant scores for depression> = 10 points; and/or
- •Insomnia complaints with significant score for insomnia> = 11; and/or
- •Complaints of significant score for anxiety> =
- •participants with significant symptoms in more than one domain, together with the professional, will be invited to elect a main focus of treatment, or by be the main problem and/or the one the patient is most motivated to treat.
排除标准
- •Individuals who have acute suicide risk, evaluated by positive response (1, 2 or 3) to PHQ-9 item 9 and considered severe (suicidal illusion) in the Suicide Risk Assessment Protocol (S-RAP) will be excluded.
- •Individuals identified as bass in S-rap will be sent for emergency care according to security monitoring protocol presented in the topic "Evaluation and Risk Monitoring" of this project.
研究组 & 干预措施
iCBT
For participants allocated to ICBT, in addition to the usual care performed in the primary unit, these individuals will also receive digital intervention through an online platform specifically developed for this purpose. Depression and anxiety intervention will consist of 10 specific modules for the treatment of each disorder to be performed within 10 weeks. Insomnia intervention will consist of 9 specific modules for the treatment of insomnia, to be performed within 8 weeks. These modules use concepts associated with cognitive behavioral therapy and third-generation behavioral therapy and were created through the transcultural and digital adaptation the therapeutic ingredients present in consumed treatment manuals in the literature.
In all modules, a therapist will be designated to accompany each patient.
干预措施: interactive technological intervention for improvement of mental health symptoms in Primary Care users Health (Device)
Treatment as usual
Patients allocated to this arm will continue to receive the usual treatment in their health units, which usually consists of psychotropic drugs and psychological support
结局指标
主要结局
PHQ-9 - Patient Health Questionnaire-9
时间窗: 3 month follow up
Reduction of 50% or more in the PHQ-9 score
ISI - Insomnia Severity Index
时间窗: 3 month follow up
Reduction of 8 points or more in the ISI score
GAD-7 - Generalized Anxiety Disorder 7-item
时间窗: 3 month follow up
Reduction of 50% or more in the GAD-7
次要结局
未报告次要终点