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临床试验/NCT02911519
NCT02911519已完成不适用

Efficacy of a Brief Group Psychoeducation Program Aimed at Patients With Schizophrenia and Their Families: A Clinical Controlled Trial

Salud Mental Integral S.A.S.0 个研究点目标入组 176 人开始时间: 2013年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
176
主要终点
Number of Participants With Relapse

研究概览

简要总结

This study evaluates the addition of psychoeducation to treatment as usual in the treatment of adults with schizophrenia for relapse prevention. Half of participants will receive a brief (5 sessions) psychoeducation intervention and treatment as usual in combination, while the other half will receive treatment as usual only.

详细描述

Schizophrenia is a chronic persistent and disabling psychiatric syndrome whose primary feature is the presence of delusions, hallucinations, disorganized speech or behavior, catatonic behavior and negative symptoms (poverty of thought, social isolation, decreased expression of emotions and motivation for activities). Its incidence in one year is 15.9 per 100,000 inhabitants; its prevalence is 4.3 per 1,000 inhabitants and has been shown to be more common among men, migrant population, urban area, developed countries and greater latitude. It is associated with: 1) Increased mortality rates compared to the general population 2) Disability is one of the top ten causes of years lived with disability in people between 15 and 44 years old, which can be explained by incomplete remission of up to 80% of affected patients and psychotic relapses (5-7). 3) High economic costs given by relapses, hospitalizations, decreased labor productivity and financial and emotional burden for families (8,9). The latter has increased in the last 50 years by changes in the mental health care systems throughout the world that have left families a greater responsibility in caring for patients so they would need more knowledge about the disorder, treatment and rehabilitation (10,11). All this justifies the search for strategies aimed at preventing psychosis crisis increase the period between crises and decrease disability (12,13,14). Psychoeducation is one of the strategies that have been raised so far (15).

Psychoeducation is an intervention based on the structured and systematic knowledge acquisition of a mental disorder, with the aim of improving their clinical prognosis and reduce care costs (15,16,17). There are various designs of psychoeducative programs, they can be individual or group, involving only patients, family or both, or short (less than 10 sessions) or longer. There is insufficient evidence to establish whether any of these methods is most effective, and with respect to the psychoeducation in general, available studies suggest that it may have beneficial effect on reduction in relapses, adherence, hospital stay, global functioning and quality of life (19). However, these studies have methodological limitations such as lack of clarity in the generation and concealment of randomized allocation sequence, non-blind assessment of outcomes and frequent losses in monitoring, suggesting that the effects observed for psychoeducation may not be valid and could be overestimated. Additionally, the cultural characteristics and health system of each country may limit the applicability of studies, which may be necessary to evaluate the efficacy in sites with particular conditions (20).

In a private psychiatric clinic in Medellin primarily serving patients who belong to the contributory scheme of health care, Brief Psychoeducation Group Program was designed (five sessions) for Patients with Schizophrenia and their Families (PGSF). It was decided to include both patients and relatives because some studies suggest there may be advantages and generally patients with this disorder should go out accompanied. It will be group because some authors have argued that it could have more benefits than individual, to facilitate meetings with others, by facilitating the encounter with other people with similar conditions, which could have additional therapeutic effects and be more cost-effective (19). It will be five sessions because it was considered that they could cover the main issues and ensure the attendance at all sessions, taking into account the economic conditions and time restrictions most for most relatives. It is very important to evaluate the effectiveness of this program because that will allow making informed decisions regarding the implementation in this and other psychiatric care institutions in the country. In addition, there are not any controlled clinical trials in Colombia that evaluate the effectiveness of a psychoeducational intervention for this disorder.

Therefore, the research question is: In a psychiatric clinic of Medellin (Colombia), What is the effectiveness of a Brief Psychoeducational Group Program for Patients with Schizophrenia and their Families (PGSF) added to their Outpatient Treatment as Usual (TAU) compared with TAU to reduce the risk of relapse?

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of schizophrenia according to the International Classification of Diseases in its tenth edition (ICD-10).
  • The relative who attend the PGSF must have lived with the patient in the last year and is preferred to be their primary caregiver.
  • Agree to participate in the investigation.

排除标准

  • Be involved in another group psychoeducation program.
  • Have clinically significant psychotic symptoms that indicate "decompensation" with a score in the Clinical Global Impressions Scale for severity (CGI-S) 3 or greater.
  • Moderate mental retardation
  • Drug Addiction. (Consumption of active illegal psychoactive substances or alcohol during the last three months.
  • Medical comorbidity whose life expectancy is less than one year.

结局指标

主要结局

Number of Participants With Relapse

时间窗: 12 months

Defined as the reappearance of criteria for an episode of psychosis in a patient who did not or only had residual symptoms. It can be set in two ways: hospitalization or a score on the CGI-S greater than or equal to 3 in the evaluation and an increase greater than 20% in the Scale for the Assessment of Positive Symptoms (SAPS)

次要结局

  • Symptoms of Schizophrenia(12 months)
  • Expressed Emotions(12 months)
  • Adherence to Treatment(12 months)
  • Insight(12 months)
  • Number of Patients With Hospitalization(12 months)
  • Quality of Life Measure by WHOQOL-BREF(12 months)
  • Family Burden(12 months)

研究者

发起方
Salud Mental Integral S.A.S.
申办方类型
Other
责任方
Sponsor

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