Effectiveness of an Internet-based Intervention for the Treatment of Depression: Towards the Improvement of the Management of Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- Change in depressivity assessed with the Beck's Depression Inventory I (BDI-I)
研究概览
简要总结
Depression is a highly prevalent disorder in Chile, generating important personal and social costs. This study aims to evaluate the effectiveness of the internet-based program ASCENSO as an adjunct intervention for the treatment of depression. ASCENSO provides information to promote patients' self-care, it monitors reported depression symptoms providing automatized feedback and provides the possibility of booking a counseling session via chat or by phone. To evaluate the effectiveness of ASCENSO, an open, evaluator-blind, prospective, parallel-group (one intervention group and one active control group) randomized controlled trial will be implemented in one mental health center in Santiago of Chile. The sample will be composed of adults initiating treatment for depression, and who have internet access. Participants will be randomly assigned to one of the two study arms. Randomization will be stratified by the number of patients´ previous episodes (dichotomized into none, 1 or more), following a permuted block randomization procedure. Patients in the experimental group (n=100) will receive the usual treatment plus access to the ASCENSO program. The control group (n=100) will only receive the usual treatment. At recruitment, months 6 and 9, patients' self-reported depression symptoms and quality of life will be assessed. Additionally, adherence to treatment in terms of patients' attendance to medical controls and psychotherapy sessions will be registered for both research groups.
详细描述
The public health system has established policies and priorities to provide access to depression treatment and to improve the quality of those services. The acknowledgment of the complexity and chronicity of the disorder has motivated the design and implementation of comprehensive disease management strategies for depression. There are experiences that show that information technologies can help to optimize the management of depression. If ASCENSO is effective, it could be a useful resource to include to the mental health services for depression in Chile.
The components of the ASCENSO program are:
Emergency. Standard Information on what to do and who to contact in a crisis situation.
Online or phone counseling. Patients can schedule a 30-minute session with a psychologist, which is conducted in a private text chatroom or over the phone.
Monitoring. Patients receive a bi-weekly email with a link to the monitoring questionnaire and automatized tailored feedback message. If a participant reports severe impairment, the ASCENSO administrator receives an alert notification and then contacts the patient.
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 (Outcomes Assessor)
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
- •Clinical diagnosis of major depression disorder
- •Internet access
排除标准
- •previous suicide attempt
- •hospitalization for a previous depressive episode
- •a history of psychotic symptoms
- •bipolar disorder
- •organic brain disorders
- •any serious disorders related to substance abuse or dependence
- •antisocial personality disorder
- •a serious medical condition or severe cognitive impairment
- •lack of knowledge of the Spanish language
- •illiteracy
- •refusal or revocation of patient consent.
- •Patients will be evaluated using the MINI International Neuropsychiatric interview, Spanish for Chile Translation Version 6.0.0.
研究组 & 干预措施
Experimental
Participants receive psychiatric treatment and psychotherapy as usual. In addition, participants have access to the internet-based program ASCENSO: an adjunct support and monitoring system for the treatment of depression.
干预措施: Antidepressants or in combination with anxiolytics, neuroleptics or mood stabilizers. (Drug)
Control
Patients receive psychiatric treatment and psychotherapy as usual.
干预措施: Antidepressants or in combination with anxiolytics, neuroleptics or mood stabilizers. (Drug)
Experimental
Participants receive psychiatric treatment and psychotherapy as usual. In addition, participants have access to the internet-based program ASCENSO: an adjunct support and monitoring system for the treatment of depression.
干预措施: ASCENSO (Behavioral)
Control
Patients receive psychiatric treatment and psychotherapy as usual.
干预措施: Psychotherapy (Behavioral)
Experimental
Participants receive psychiatric treatment and psychotherapy as usual. In addition, participants have access to the internet-based program ASCENSO: an adjunct support and monitoring system for the treatment of depression.
干预措施: Psychotherapy (Behavioral)
结局指标
主要结局
Change in depressivity assessed with the Beck's Depression Inventory I (BDI-I)
时间窗: Baseline, months 6 and 9.
Beck's Depression Inventory I (BDI-I) total score (score range 0 - 63)
次要结局
- Change in quality of life change assessed with the EuroQol/EQ-5D(Baseline, months 6 and 9.)
研究者
Álvaro Carrasco
Researcher
Instituto Milenio para Investigación en Depresión y Personalidad