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临床试验/NCT01631500
NCT01631500已完成不适用

Effects of an Integrative Treatment Model to Reduce Anxiety and Depression in Minor Mental Health Problems and Medically Unexplained Symptoms

Göteborg University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年1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
120
试验地点
1
主要终点
Pre-post treatment change in anxiety as assessed with the Hospital Anxiety and Depression scale (HAD)

研究概览

简要总结

Minor mental health problems, MMHP, like mild depression and anxiety, and medically unexplained symptoms, MUS, symptoms with no known underlying organic disease, are strongly associated to each other. MMHP and MUS have an impact on well-being and quality of life, lead to impaired social and cognitive function and could result in reduced work capacity. The investigators have designed the present study as a pragmatic trial to investigate the effectiveness of an integrative treatment model, therapeutic acupuncture, versus conventional treatment in patients with MMHP or MUS in primary care. The investigators examined whether the effects of the integrative treatment model differed from those achieved with therapeutic acupuncture or conventional treatment. Primary endpoints were anxiety and depression (assessed with the Hospital Anxiety and Depression scale), health-related quality of life (SF-36) and coping with stress, sense of coherence (SOC) during the eight weeks of treatment interventions.

Statistical power was calculated based on an expected 50% reduction in HAD anxiety and depression scores after eight weeks of integrative treatment; a 30% reduction in acupuncture; and 20% in conventional care. A total of 120 (40/arm) were needed to achieve a power of 83% at p <0.05. Treatment effects were calculated as the difference between values at baseline, after four weeks and after the complete intervention period, i.e. after eight weeks. Nonparametric analyses were carried out to test differences between independent samples (Kruskal-Wallis and Mann-Whitney U) and related samples (Wilcoxon).

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
20 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • one or more symptoms of emotional and physical fatigue
  • depression
  • sleep disturbances or somatic pain

排除标准

  • 100% sick leave > 2,5 years
  • pregnancy
  • personality disorders
  • substance use disorders or prescribed sedative drugs

结局指标

主要结局

Pre-post treatment change in anxiety as assessed with the Hospital Anxiety and Depression scale (HAD)

时间窗: Baseline and after eight weeks of treatment completion

Change in HAD Anxiety between baseline and 8-week follow up

次要结局

  • Pre-post treatment change in health-related quality of life (assessed with the SF-36 Mental Component Summary score(MCS))(Baseline and after eight weeks of treatment completion)
  • Pre-post treatment change in sense of coherence (SOC)(Baseline and after eight weeks of treatment completion)
  • Pre-post treatment change in depression as assessed with the Hospital Anxiety and Depression scale (HAD)(Baseline and after eight weeks of treatment completion)

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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