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临床试验/NCT03622151
NCT03622151已完成不适用

Homeless Population and Mental Health: Impact of Primer la Llar Program

Parc Sanitari Sant Joan de Déu0 个研究点目标入组 86 人开始时间: 2016年1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
已完成
发起方
入组人数
86
主要终点
Prevalence and gravity of psychotic symptoms in both groups

研究概览

简要总结

The main goal is to evaluate the impact of the Primer La Llar housing program for the homeless population on the mental health of the participants.

The hypothesis is that the housing program, which follows Housing first model, for the homeless population has a positive impact on the mental health of the participants, compared to the group that does not receive the intervention -treatment as usual group (meaning the "positive impact" a lower score on the symptomatology scales and lower toxic intake in the group receiving the intervention).

详细描述

The specific objectives are:

Identify the socio-demographic and clinical characteristics of the participants.

Compare the severity of psychiatric symptoms and improvement among the participants in the intervention group and the control group (depressive, anxious, psychotic or manic symptomatology, depending on the case).

Compare the consumption of alcohol and drugs among the participants of both groups.

Compare the basic daily life skills among the participants in both groups, as well as the improvement of them in the experimental group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 72 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Single people, adults (exceptionally sentimental couples, friends with positive support relationship for both).
  • Long life on the street (minimum 1 year staying overnight on the street) and / or accommodation centers without linking, using them in a timely manner in the last year.
  • Social needs concurrent to the lack of housing: mental illness and / or drug abuse.
  • Functional autonomy for daily life.
  • Have regular economic income or possibility of obtaining them.
  • Sign informed consent form.

排除标准

  • language barrier
  • severe neurological or organic pathology
  • severe dementia
  • alcoholic dementia Wernicke Korsakoff

研究组 & 干预措施

Intervention group

Experimental

Primer la Llar Program (housing first model): to live in permanent and individual housing and receiving weekly visits from a multidisciplinary team.

干预措施: Primer la Llar program (Other)

Control group

No Intervention

Treatment as usual:

attention from the resources of the homeless network in Barcelona.

结局指标

主要结局

Prevalence and gravity of psychotic symptoms in both groups

时间窗: Up to 21 months

PANSS scale (Positive And Negative Syndrome Scale). Subscales: 1. PANSS-P-Positive (7 ítems): range 7-49 (minimum and maximum scores) 2. PANSS-N-Negative (7 ítems). Range: 7-49. 3. PANSS-PG- general psychopathology (16 ítems). Range: 16-112. Higher values represent a worse outcome. Subscales are summed to compute a total score.

Prevalence and gravity of anxious symptoms in both groups

时间窗: Up to 21 months

HARS scale (Hamilton Anxiety Rating Scale). Total range:0-56. Higher values represent a worse outcome.

Prevalence and gravity of depressive symptoms in both groups

时间窗: Up to 21 months.

HDRS scale (Hamilton Depression Rating Scale). Total range: 0-52. Higher values represent a worse outcome.

次要结局

  • Changes in number of visits to the emergency room/health center/specialist doctors(Up to 21 months)
  • Basic skills of daily life(Up to 21 months)
  • Sociodemographic and psychopathological description of both groups(Up to 21 months)
  • Number of participants with an alcohol abuse problem assessed by Audit test(Up to 21 months)
  • Number of participants with a drug abuse problem assessed by questionnaire on drug abuse(Up to 21 months)

研究者

发起方
Parc Sanitari Sant Joan de Déu
申办方类型
Other
责任方
Principal Investigator
主要研究者

Inés Campo Ferreiro

Mental Health Nurse

Parc Sanitari Sant Joan de Déu

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