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临床试验/NCT01786733
NCT01786733已完成不适用

Psychotherapy in the Transition From Acute Psychiatric Inpatient Wards to Outpatient Services - A Randomized Controlled Trial of Behavioral Activation vs. Supportive Therapy

Uppsala University0 个研究点目标入组 64 人开始时间: 2013年3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
64
主要终点
Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)

研究概览

简要总结

The purpose of this study is to compare the effectiveness of Behavioral Activation and Supportive Therapy added to the standard acute psychiatric inpatient care. Therapy starts during inpatient care and can continue in an outpatient facility if the patients are discharged before 12 sessions has been completed.

详细描述

Psychiatric inpatient care is reserved for individuals with the most acute mental health problems. The period after discharge is associated with increased risk for relapse, non-adherence and suicide. Delivering high quality psychosocial interventions during and after acute psychiatric inpatient care is known to be a difficult challenge. This study will investigate the effectiveness of adding either Behavioral Activation or Supportive Therapy to the standard acute psychiatric inpatient care. Subjects with different psychiatric diagnoses and elevated depressive symptoms are assessed and randomized after admission. Therapists from the nearest outpatient facility initiate 12 sessions of Behavioral Activation or Supportive Therapy as soon as possible. The 12 sessions are delivered twice weekly at the inpatient unit or at the outpatient facility, depending on whether the patient is admitted or discharged. Treatment as usual interventions(medications, nursing etc.) are not manipulated in the study. The main assessment points are pre-, post, 6 months follow-up and 12 months follow-up. The main outcome measure and some process measures are also administered at session 3, 6 and 9.

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 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Admitted into one of four acute psychiatric inpatient units in Dalarna
  • MADRS-S 20 and above at acute admission and and after 2-3 days on the ward
  • Psychiatric disorder according to M.I.N.I (Sheehan et al., 1998)
  • Read and Speak Swedish

排除标准

  • Acute psychotic symptoms
  • Acute manic symptoms
  • Confusion
  • Primary eating disorder
  • Primary alcohol or substance abuse disorder
  • Self rated score on AUDIT (Saunders et al., 1993)of 20 or greater
  • Mental retardation

结局指标

主要结局

Change from Baseline in Montgomery-Åsberg Depression Rating Scale (Self-report version) (MADRS-S)

时间窗: 12 months

次要结局

  • Change from baseline in Global Assessment of Functioning (GAF)(12 months)
  • Change from baseline in The Sheehan Disability Scale (SDS)(12 months)
  • Change from baseline in EuroQol 5 Dimension Scale (EQ5D)(12 months)
  • Change from baseline in sick leave and employment status(12 months)
  • Change from baseline in Mini-International Neuropsychiatric Interview (M.I.N.I)(12 months)
  • Change from baseline in Clinical Global Impression (CGI)(12 months)
  • Change from baseline in Alcohol Disorders Identification Test (AUDIT)(12 months)
  • Change from baseline in Behavioral Activation for Depression Scale, Short Form (BADS-SF)(12 months)
  • Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS)(12 months)
  • Change from baseline in Usage of mental health care(12 months)

研究者

发起方
Uppsala University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fredrik Folke

PhD-student

Uppsala University

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