跳至主要内容
临床试验/NCT01726387
NCT01726387已完成不适用

Self-Management Support in Primary Care

Universitätsklinikum Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 364 人开始时间: 2013年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
364
试验地点
1
主要终点
General Self-Efficacy Scale (GSE)

研究概览

简要总结

Anxiety, Depression and Somatoform disorders are highly prevalent in primary care. Very often these conditions remain undiscovered and/or untreated.

In order to ease this urgent health care problem in the future, the investigators conduct a cluster-randomized controlled trial, implementing a tandem working cooperation between a nurse practitioner (Counseling Assistant - CA) and a general practitioner (GP) on-site its own practise.

The CA's task is to enhance the patients abilities to engage in a better self-management of their psychological symptoms and complaints, to enhance self-efficacy and empower the patients to tackle problems of daily living.

详细描述

Anxiety, Depression and Somatoform disorders are highly prevalent in primary care. Very often these conditions remain undiscovered and/or untreated. Managing it is time-consuming and communication-intensive. Furthermore, the management is restraint by the high contact-frequencies in primary care practices in Germany.

In order to ease this urgent health care problem in the future, the investigators conduct a cluster-randomized controlled trial, implementing a tandem working cooperation between a nurse practitioner (Counseling Assistant - CA) and a general practitioner (GP) on-site its own practise.

The CA's task is to enhance the patients abilities to engage in a better self-management of their psychological symptoms and complaints, to enhance self-efficacy and empower the patients to tackle problems of daily living.

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
All
接受健康志愿者

入选标准

  • Patients scoring >= 5 on the Patient Health Questionnaire (German Version), corresponding to a probable or established diagnosis of Anxiety, Depression or Somatoform Disorder

排除标准

  • Negation of Inclusion Criteria

研究组 & 干预措施

Psychosocial Counseling

Experimental

A Counseling Assistant offers a low-threshold intervention (self-management support, counseling, active guidance). This nurse practitioner collaborates extensively with the general practitioner, re-adjusting the intervention in order to meet the patient's needs.

干预措施: Psychosocial Counseling (Behavioral)

Usual Care

Placebo Comparator

Depending on the conditions, patients get usual care of their general practitioner.

干预措施: Usual Care (Behavioral)

结局指标

主要结局

General Self-Efficacy Scale (GSE)

时间窗: Baseline, 8 Weeks, 12 Months

GSE assesses a general sense of perceived self-efficacy. It predicts coping with daily hassles as well as adaptation after experiencing all kinds of stressful life events. http://userpage.fu-berlin.de/%7Ehealth/engscal.htm "The construct of Perceived Self-Efficacy reflects an optimistic self-belief (Schwarzer, 1992). This is the belief that one can perform a novel or difficult tasks, or cope with adversity -- in various domains of human functioning. Perceived self-efficacy facilitates goal-setting, effort investment, persistence in face of barriers and recovery from setbacks. It can be regarded as a positive resistance resource factor. Ten items are designed to tap this construct. Each item refers to successful coping and implies an internal-stable attribution of success. Perceived self-efficacy is an operative construct, i.e., it is related to subsequent behavior and, therefore, is relevant for clinical practice and behavior change."

次要结局

  • Change in Symptom Score Patient's Health Questionnaire (German Version)(Baseline, 8 Weeks, 12 Months)
  • Health Related Quality of Life(Baseline, 8 Weeks, 12 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Self-Management for Anxiety, Depression and... | 临床试验