跳至主要内容
临床试验/NCT06480019
NCT06480019招募中不适用

IPT-based Group Intervention by Non-specialist for Improvement of Depressive Symptoms in Community Young Adults in Brazil: a Randomized Clinical Trial

Hospital de Clinicas de Porto Alegre2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Hospital Anxiety and Depression Scale (HADS)

研究概览

简要总结

Major depressive disorder is a highly prevalent, recurrent, and debilitating disease, the third cause of years of lost life in the world, and it may be the most common disease in 2030, according to the World Health Organization (WHO). Furthermore, it's also related to decreased quality of life and high mortality. Interpersonal psychotherapy (IPT) is a first-line treatment and can also be used for the prevention of depression.

This randomized controlled clinical trial is planned to have 50 participants randomized between an interventional and a control group (waiting list). Our study covers young adults (18 to 24 years old) with depression. Participants will be invited by social media to undergo treatment in an IPT group. The intervention group will be separated into groups with up to 10 participants, with a weekly meeting for eight weeks. The intervention will focus on interpersonal relationships within the model of IPT and will be held by a university student and a doctor trained in IPT.

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
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 24 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Young adults (between 18 and 24 years old)
  • Young adults who work, live or study in Porto Alegre
  • PHQ ≥ 5 - without suicide ideation

排除标准

  • Maniac or hypomanic episode
  • Psychotic Syndrome
  • Substance Abuse
  • Suicide Risk or Ideation

研究组 & 干预措施

Intervention

Other

Participants that receive psychotherapy

干预措施: Interpersonal psychotherapy (Behavioral)

Waiting list

No Intervention

Participants that are waiting for intervention

结局指标

主要结局

Hospital Anxiety and Depression Scale (HADS)

时间窗: Pre-treatment, Week 1 to 8

The Hospital Anxiety and Depression Scale consists of 14 items, of which 7 assess anxiety and 7 assess depression. Each item is scored from 0 to 3, and each subscale has a maximum score of 21 points with higher scores indicating greater symptom severity.

Hospital Anxiety and Depression Scale (HADS)

时间窗: Pre-treatment, Week 1 to 8

The Hospital Anxiety and Depression Scale consists of 14 items, of which 7 assess anxiety and 7 assess depression. Each item is scored from 0 to 3, and each subscale has a maximum score of 21 points with higher scores indicating greater symptom severity.

次要结局

  • Clinical Global Impression (CGI)(Pre-treatment, Week 1 to 8)
  • Patient Health Questionnaire-9(Pre-treatment, Week 1 to 8)
  • Social support scale (MOS-SSS)(Pre-treatment, Week 1 to 8)
  • Quality of Life (WHOQOL-BREF)(Pre-treatment, Week 1 to 8)
  • Clinical Global Impression (CGI)(Pre-treatment, Week 1 to 8)
  • Beck Depression Inventory (BDI)(Pre-treatment; Week 1-8)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Neusa Sica da Rocha

Principal Investigator

Hospital de Clinicas de Porto Alegre

研究点 (2)

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