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临床试验/NCT05087446
NCT05087446进行中(未招募)不适用

Effect of Early Assessment Team for Clarification and Follow-up of Patients Referred to Outpatient Mental Health Care: A Randomized Controlled Trial

St. Olavs Hospital1 个研究点 分布在 1 个国家目标入组 588 人开始时间: 2021年10月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
588
试验地点
1
主要终点
Work and Social Adjustment Scale (WSAS)

研究概览

简要总结

Loss of function and incapacity for work as a result of mental disorders are increasing, especially among young people (under 30 years of age), even though the prevalence of mental illness is fairly stable. Many of the patients referred to outpatient mental health care have complex difficulties with both mental and somatic ailments, in addition to difficulties with social conditions related to, for example, education, work, finances and social support. Functional difficulties can come as a result of mental illness. However, it can also be the opposite way; not functioning at work, study or daily life in general can cause mental symptoms and ailments. Many of these people are referred to mental health care even if the basic problem cannot be solved by psychotherapy or medication. Some of the referred patients do not have a psychiatric illness, but a reaction to a stressful and demanding situation and strains over time. Compound health challenges require individualized assessments and clarifications in order to offer the right measures. Traditionally in mental health care, the patient is placed on a waiting list to receive assessment and therapy for a specific condition.

With this background, the investigators believe it is important to early identify the referred patients who will benefit from measures other than traditional assessment and treatment in mental health care. Knowledge of other aid agencies is important to find the right measures at the right time. This is important for the individual patients, who are often young people going to "get started in life". It is also important for the health services because the capacity to provide a good health service is a limited resource. From a societal perspective it is important that the health care offered contributes to reducing social security dependence.

The purpose of this randomized, controlled trial is to compare the effect of traditional management of newly referred patients in outpatient clinics with assessment through an Early Assessment Team. The investigators believe that early assessment may have a positive effect on mental health, quality of life and function. The outcome goals can be summarized as less use of resources in outpatient clinics and society and better function and life for patients.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients referred to a general psychiatric outpatient clinic
  • necessary capacity to consent
  • master Norwegian language to such an extent that the patient can understand the written consent

排除标准

  • patients that an admission team at the outpatient clinic consider obviously must have a TAU for some time
  • patients too healthy to receive specialized mental health care
  • patients in need of acute psychiatric assessment
  • relevant participants who do not respond digitally or who do not confirm consent in writing within given deadlines

研究组 & 干预措施

Early assessment group

Experimental

干预措施: Early assessment team (Behavioral)

Usual admission procedure group

Active Comparator

干预措施: Admission to General psychiatric outpatient clinic (Behavioral)

结局指标

主要结局

Work and Social Adjustment Scale (WSAS)

时间窗: 1 year

WSAS is a self-report questionnaire with five items covering the following dimensions; influence on work, home management, social leisure activity, private leisure activities and relationships with others. The items are scored from 0 to 8, with a total score from minimum 0 to maximum 40, with lower scores indicating better adjustment.

次要结局

  • Clinical Outcome in Routine Evaluation Outcome Measure (CORE-10)(2, 4, 8 months after enrollment)
  • The Questionaire about the Process of Recovery (QPR-15)(2, 4, 8, 12, 24 months after enrollment)
  • EuroQoL EQ-5D-5L(2, 4, 8, 12, 24 months after enrollment)
  • World Health Organization Well Being Index (WHO-5)(2, 4, 8, 12, 24 months after enrollment)
  • Client Satisfaction Questionnaire (CSQ-8)(Through study completion, an average of 1 year)
  • Clinical Outcome in Routine Evaluation Outcome Measure (CORE-OM)(12, 24 months after enrollment)
  • Occupational status - data extracted from The Norwegian Labour and Welfare Administration (NAV)(12 and 24 months)
  • Work and Social Adjustment Scale (WSAS)(2, 4, 8, 24 months after enrollment)

研究者

发起方
St. Olavs Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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