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临床试验/NCT05482217
NCT05482217已完成不适用

The Effectiveness of Psychoeducation and Problem-solving (Life-steps) on Depression and Treatment Adherence in HIV Infected Adolescents: an Exploratory Randomized Controlled Trial

University of Botswana1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年7月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Depressive symptoms were measured with Patient Health Questionnaire (PHQ-9), has sensitivity and specificity of 0.8 and 0.7. The cut-off of nine or more was consistent with a diagnosis of depression

研究概览

简要总结

Aim: To explore the effectiveness of psychoeducation and problem-solving (Life-steps) on depression and adherence in HIV-infected adolescents.

Methods: Forty-two adolescents were randomized into 21 controls and 21 intervention groups. The intervention group was exposed to 5-week sessions of life steps applied by a lay counselor. The PHQ-9 and visual analog scale (VAS) were used to measure the outcomes: depression and adherence. They were applied at baseline, 5-weeks, and 24 weeks post-intervention.

详细描述

General objectives

To explore the effect of psychoeducation and problem solving (LIFE STEPS) technique on medication adherence and depression among mentally ill ALWHIV in Botswana.

Specific Objectives

  1. To compare the sociodemographic and clinical variables of the ALWHIV: intervention and control group
  2. To explore the effect of psychoeducation and problem solving (LIFE STEPS) on medication adherence and depression among ALWHIV.

Methodology Study Design: Randomised controlled trial to assess the psychological intervention program.

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 (Participant)

入排标准

年龄范围
12 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • HIV infected adolescents aged, 12 - 19 years
  • On ART for a minimum of six months.
  • Speak or communicate in Setswana or English.
  • Outpatient
  • Willing to participate

排除标准

  • Psychotic, and intellectually disabled patients

结局指标

主要结局

Depressive symptoms were measured with Patient Health Questionnaire (PHQ-9), has sensitivity and specificity of 0.8 and 0.7. The cut-off of nine or more was consistent with a diagnosis of depression

时间窗: 5 weeks

Change in PHQ-9 score or change in depressive symptoms score

次要结局

  • Medication adherence: measured with the Visual Analogue Scale (VAS), a horizontal line, 10cm long, and calibrated by 5 from 0 to 100. Score of <95% is suboptimal adherence based on 30 days pill use. It exhibits medium to large strength (r = 0.5-0.7).(5 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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