跳至主要内容
临床试验/NCT03047512
NCT03047512Unknown不适用

Pilot Study of an Internet-based Program for Prevention and Early Intervention of Adolescent Depression

CES University8 个研究点 分布在 1 个国家目标入组 213 人开始时间: 2017年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
213
试验地点
8
主要终点
Change from Baseline Depressive Symptomatology

研究概览

简要总结

Major depression is a highly prevalent and severe mental disease that negatively alters the lives of people, their families, and their social environment.

Organizations that promote mental health policies have recognized the potential of new information technologies for the prevention and treatment of mental disorders. In this direction, information and communication technologies (ICTs) generate opportunities for increasing patient well-being through the use of on-line software. Such programs often include interactivity, self-monitoring, information materials (sometimes in multimedia format), and exercises on problem solving, recognition and challenging of dysfunctional thoughts, scheduling of activities, behavioral experiments, and other psycho-educational activities.

In Colombia, there are few preventive mental health interventions scientifically oriented and seeking to demonstrate efficacy in context.

The purpose of this study is to determine whether an internet-based program is effective to prevent and to intervene early the depression in adolescents between 11 and 20 years of age in 2 schools in the Antioquia Region, Colombia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
11 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adolescents who study in schools in Antioquia from sixth grade to tenth grade, who can access the internet and a psychological service in case of moderate or severe depressive symptoms.

排除标准

  • •High suicide risk defined by: A score equal to or greater than 2 in the question 9 of the PHQ-9A, an adolescent who is undergoing treatment with antidepressants and / or currently attends psychotherapy

研究组 & 干预措施

Internet-based program

Experimental

The internet based program includes the following modules: (1) information and psychoeducational material, (2) symptom monitoring with personalized automatic feedback, (3) forum (peer support moderated by mental health professionals) and (4) chat (individualized support by mental health professionals). It also considers (5) the referral to face-to-face treatment of cases with symptoms that require it. (6) In addition to the web page in the institutions, there will be a monthly health promotion booth during breaks.

干预措施: Experimental: Internet-based program (Behavioral)

Control Group

No Intervention

The control group will receive two psychoeducational workshops / conferences. In addition, the adolescents in the control group can participate in the monthly health promotion booths offered by the program.

结局指标

主要结局

Change from Baseline Depressive Symptomatology

时间窗: Baseline, 4 months, 12 months

Depressive symptomatology measured with the Patient Health Questionnaire PHQ -9

次要结局

  • Change from Baseline in Health Related Quality(Baseline, 4 months, 12 months)
  • Change from Baseline in anxious symptoms(Baseline, 4 months, 12 months)
  • Change from Baseline in of depression(Baseline, 4 months, 12 month)

研究者

发起方
CES University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Henry Daniel Espinosa Duque

PhD

CES University

研究点 (8)

Loading locations...

相似试验