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临床试验/NCT01907035
NCT01907035Unknown3 期

Improving Anxiety-depressive Disorder in Primary Care Applying a Cognitive-behavioral Treatment, Applied by Psychologists.

Basque Health Service3 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2012年8月1日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
246
试验地点
3
主要终点
Life Quality

研究概览

简要总结

OBJECTIVE: Evaluate the effectiveness of quality of life score, a cognitive-behavioral intervention by psychologists in the field of primary care in anxiety-depressive patients, mild to moderate, compared with usual care.

DESIGN: Clinical trial, multicenter, prospective, and randomized into two parallel groups. SCOPE AND SUBJECTS: We included a random sample of 246 patients anxious-depressive, mild / moderate, belonging to the target population of 41 doctors from several health centers. INTERVENTION: In the 246 patients randomly assigned to the intervention group, with a standardized program of cognitive behavioral therapy applied by psychologists, by the usual treatment or control group, which will be standard care. MEASUREMENTS: The main result will be changes in general health scores of the SF-36. It will also measure the change in frequency and intensity of anxiety-depressive symptoms on the scales HARS, HDRS, STAI and BDI at baseline and at 2, 6 and 12 months. In addition, also collected for drug use and health services.

ANALYSIS: Analyses were performed by intention to treat, comparing the change obtained in both groups at the end of the 12 month follow up. Estimates of the effect attributable to the intervention by the difference in those changes, adjusting in addition to the baseline, the possible confounding covariates or effect modifiers of the intervention, using longitudinal mixed-effects models.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary care patients.
  • Of both sexes.
  • With disorder mixed anxiety-depressive mild-moderate active diagnosed by their general practitioner and showing more than 4 points in Goldberg-Anxiety, and more than 3 in Goldberg Depression.

排除标准

  • Patients under 18 or over 75 years
  • Patients with inability to understand, read or speak Spanish
  • Patients with cognitive impairment
  • Patients with severe disease which in the opinion of your doctor have a presumably fatal end during the 12 month follow-up
  • Patients with psychotic disorders or other serious mental disease
  • Patients with attempted suicide or suicidal ideation persistent
  • Patients referred to Specialized Care
  • Patients who are in private treatment
  • Patients with high probability of loss to follow up.

结局指标

主要结局

Life Quality

时间窗: The change from basal point to 2, 6 and 12 months

Change in the scale SF-36

次要结局

  • Use of pharmacotherapy and sanitary services(The change from baseline point to 12 months)

研究者

发起方
Basque Health Service
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Amale Jauregui Larrabeiti

IPrincipal Investigator

Basque Health Service

研究点 (3)

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