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临床试验/NCT04343391
NCT04343391已完成不适用

Brief Psychotherapies for Emotional Disorders in Primary and Secondary Care: A Randomized Controlled Trial

Universidad de Córdoba1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年1月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Patient Health Questionnaire (PHQ-15)

研究概览

简要总结

The present work aims to develop a randomized clinical trial with a sample of 150 patients diagnosed with at least one of the following emotional disorder: somatoform disorder, panic disorder, generalized anxiety disorder and depression disorder. Participants are tested by several self-reports related to the emocional disorders mentioned in a repeated measures design, pre and post treatment. The investigators think this study will demonstrate that brief psychological treatments should be prioritized over pharmacological treatment for such pathologies in the Primary or Secondary Care context to improve the patient´s quality of life.

详细描述

Nowadays, the heavy demands placed on health systems exceed the resources in many developed countries. So-called "emotional disorders" and their mostly pharmacological treatment are, in no small part, responsible for this situation. However, research indicates that psychological treatment should be the first step when caring for these types of problems. The investigators expect that the results show that brief psychological therapies are more effective than pharmacological interventions. Moreover, it is expected that brief individual psychotherpay approach delivered in secondary care is more effective than brief group psychotherapy delivered in primary care.

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
Double (Care Provider, Investigator)

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

  • Emotional Disorder

排除标准

  • Severe mental disorder
  • Substance use disorder
  • Severe depression

研究组 & 干预措施

Brief Individual Psychotherapy

Experimental

Individual brief psychological intervention by adaptation of the Guide NICE "Common Mental Health Disorders" (ISBN 978-1-84936-585-7) and the unified protocol for the trasndiagnostic treatment of the emotional disorders of Barlow (Boisseau, Farchione, Fairholme, Ellard, y Barlow, 2010). This intervention is provided by clinical psychologist in secondary care.

干预措施: Brief transdiagnostic cognitive-behavioral therapy (Behavioral)

Brief Group Psychotherapy

Experimental

Group brief psychological intervention by adaptation of the Guide NICE "Common Mental Health Disorders" (ISBN 978-1-84936-585-7) and the unified protocol for the trasndiagnostic treatment of the emotional disorders of Barlow (Boisseau, Farchione, Fairholme, Ellard, y Barlow, 2010). This intervention is provided by clinical psychologist in primary care.

干预措施: Brief transdiagnostic cognitive-behavioral therapy (Behavioral)

Treatment as usual

Active Comparator

Medication provided by a general practitioner.

干预措施: Pharmacological treatment (Drug)

结局指标

主要结局

Patient Health Questionnaire (PHQ-15)

时间窗: 10 weeks

The Patient Health Questionnaire-Somatoform Disorder is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders.The PHQ-15 is the somatization module, which scores each DSM-IV criteria as "0" (not bothered at all) to "2" (bothered a lot). The more score the more severity.

State-Trait Anxiety Inventory (STAI)

时间窗: 10 weeks

The State-Trait Anxiety Inventory is a commonly used measure of trait and state anxiety (Spielberger, Gorsuch, Lushene, Vagg, \& Jacobs, 1983). It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. It also is often used in research as an indicator of caregiver distress AnxietyForm Y, its most popular version, has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety. The STAI is appropriate for those who have at least a sixth-grade reading level. Internal consistency coefficients for the scale have ranged from .86 to .95; test-retest reliability coefficients have ranged from .65 to .75 over a 2-month interval (Spielberger et al., 1983).

Beck Depression Inventory (BDI-II)

时间窗: 10 weeks

The Beck Depression Inventory (second edition) is a widely used 21-item self-report inventory measuring the severity of depression in adolescents and adults. The BDI-II was revised in 1996 to be more consistent with DSM-IV criteria for depression. For example, individuals are asked to respond to each question based on a two-week time period rather than the one-week timeframe on the BDI. The BDI-II is widely used as an indicator of the severity of depression, but not as a diagnostic tool, and numerous studies provide evidence for its reliability and validity across different populations and cultural groups. The more score the more depression severity.

Patient Health Questionnaire (PHQ-9)

时间窗: 10 weeks

The Patient Health Questionnaire-Depression is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders.The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The more score the more severity.

Patient Health Questionnaire (PHQ-PD)

时间窗: 10 weeks

The Patient Health Questionnaire-Panic Disorder is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders.The PHQ-PD is the panic disorder module, which scores each DSM-IV criteria as "yes" or "no". Higher scores mean greater severity of panic disorder.

Generalized Anxiety Disorder score (GAD-7)

时间窗: 10 weeks

The Generalized Anxiety Disorder score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater. Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for GAD.

Brief Symptom Inventory (BSI-18)

时间窗: 10 weeks

The Brief Symptom Inventory contains the three six-item scales somatization, depression, and anxiety as well as the Global Severity Index (GSI), including all 18 items. The BSI-18 is the latest and shortest of the multidimensional versions of the Symptom-Checklist 90-R. The more score the more symptoms patients report.

次要结局

未报告次要终点

研究者

发起方
Universidad de Córdoba
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jorge Corpas López

Reseracher in Clinical Psychology

Universidad de Córdoba

研究点 (1)

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