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临床试验/NCT03586921
NCT03586921已完成3 期

Group Therapy in Primary Care for Women With Depression or Anxiety in Petropolis

Rio de Janeiro State University0 个研究点目标入组 340 人开始时间: 2006年5月19日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
340
主要终点
Depression (Beck Depression Inventory)

研究概览

简要总结

This is a randomized controlled trial comparing two groups: 1) Enhanced usual care and 2) Enhanced usual care plus group psychological intervention. In both groups a "stepped care" approach was used to the management of anxiety and depression among women seen in primary care.

详细描述

All patients received enhanced primary care, which included: (1) The nurses and doctors from the Family Health Teams were trained by Matrix team mental health professionals on clinical aspects of depression and anxiety, including diagnosis, appropriate medication interventions, psycho-education, and cognitive and problem solving therapy. (2) Given the high co-occurrence of anxiety and depression, the intervention was modified from the depression-only Chile model to emphasize co-occurring anxiety and depression in diagnoses, appropriate prescription of anxiolytics and antidepressants. (3) All providers received weekly group or individual consultation with a Matrix team mental health professional, either psychiatrist or psychologist. An qualitative study of participating Petrópolis Family Health Programme doctors and nurses demonstrated their satisfaction with the training.

Patients in the intervention arm received enhanced primary care plus a 9-session group intervention (seven sessions weekly then two sessions every 15 days). The intervention included two psycho-educational sessions with information about depression and anxiety disorders, two sessions on the development of pleasant activities including relaxation exercises, two sessions on solving problems therapy, one session on the problem of overcoming negative thoughts and emotions, one session on relapse prevention, and a final closure and review session which included a small party. The patients from the intervention arm also received additional outreach from the Family Health Teams, including home delivery of psychotropic medication when needed and active outreach and engagement by community workers if patients missed group sessions.

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
Female
接受健康志愿者
否

入选标准

  • •female patients who came to the primary care unit for any type of consultation for themselves (e.g., not for a child).
  • •General Health Questionnaire positive screen (>5 at two time points)
  • •positive diagnosis of depression or anxiety per the Mini Mental State Examination.

排除标准

  • •diagnosis of bipolar disorder, mania, severe suicidal ideation
  • •cognitive impairment that would limit their ability to consent or take part in the study. -pregnant.

研究组 & 干预措施

Enhanced usual care + group intervention

Experimental

Intervention patients received enhanced primary care plus a 9-session group intervention. The intervention included two psycho-educational sessions with information about depression and anxiety disorders, two sessions on the development of pleasant activities including relaxation exercises, two sessions on solving problems therapy, one session on the problem of overcoming negative thoughts and emotions, one session on relapse prevention, and a final closure and review session which included a small party. The patients from the intervention arm also received additional outreach from the Family Health Teams, including home delivery of psychotropic medication when needed and active outreach and engagement by community workers if patients missed group sessions.

干预措施: Psychosocial Group Intervention (Behavioral)

Enhanced Usual Care

Active Comparator

All patients received enhanced primary care: (1) Nurses and doctors from the Family Health Teams were trained by Matrix team mental health professionals on clinical aspects of depression and anxiety. (2) Given the high co-occurrence of anxiety and depression, the intervention was modified from the depression-only Chile model to emphasize co-occurring anxiety and depression in diagnoses, appropriate prescription of anxiolytics and antidepressants. (3) All providers received weekly group or individual consultation with a Matrix team mental health professional, either psychiatrist or psychologist. An qualitative study of participating Petrópolis Family Health Programme doctors and nurses demonstrated their satisfaction with the training.

干预措施: Enhanced Usual Care (Other)

结局指标

主要结局

Depression (Beck Depression Inventory)

时间窗: Change in depression 8 months post intervention

Depression measured by the Beck Depression Inventory

Depression (Beck Depression Inventory)

时间窗: Change in depression 4 months post intervention

Depression measured by the Beck Depression Inventory

次要结局

  • Anxiety (Beck Anxiety Inventory)(8 months post intervention)
  • Quality of Life (World Health Organization Quality of Life Assessment, Brief Version)(8 months post intervention)
  • Anxiety (Beck Anxiety Inventory)(4 months post intervention)
  • Quality of Life (World Health Organization Quality of Life Assessment, Brief Version)(4 months and 8 months post intervention)
  • Quality of Life (World Health Organization Quality of Life Assessment, Brief Version)(4 months post intervention)

研究者

发起方
Rio de Janeiro State University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rosely Sichieri

Associate Professor

Rio de Janeiro State University

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