Brief Group Psychotherapy for Anxiety and Depression: A Randomized Controlled Trial of Efficacy and Mechanisms of Change
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Generalised Anxiety Disorder Assessment (GAD-7)
研究概览
简要总结
The present work aims to develop a randomized clinical trial with a sample of 100 patients diagnosed with anxiety and depression in primary care. All participants are tested by several self-reports related to emotional disorders in a repeated measures design, pre and post treatment. It is our aim this study will demonstrate that brief psychological treatments should be prioritized over pharmacological treatment in Primary Care. In addition, emotional regulation will be assessed and examined as a key factor in the clinical improvement.
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 (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
- 否
入选标准
- •Depression
排除标准
- •Severe mental disroders
- •Drug abuse
- •Suicidal ideation/severe depression
研究组 & 干预措施
Brief group psychotherapy
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 et al., 2010). This intervention is provided by clinical psychologist in primary care.
干预措施: Psychological treatment (Behavioral)
Treatment as usual (TAU)
Medication provided by a general practitioner.
干预措施: Medication (Drug)
结局指标
主要结局
Generalised Anxiety Disorder Assessment (GAD-7)
时间窗: 12 weeks
The GAD-7 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.
The Patient Health Questionnaire (PHQ-9)
时间窗: 12 weeks
The Patient Health Questionnaire (PHQ) 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 Patient Health Questionnaire (PHQ-15)
时间窗: 12 weeks
It asseses somatoform symptoms. Scores could vary between 0-30 points.
Patient Health Questionnaire-Panic Disorder (PHQ-PD)
时间窗: 12 weeks
It measures panic disorder symotmos. Scores vould vary between 0-15 points.
Beck Depression Inventory-Second Edition (BDI-II)
时间窗: 12 weeks
The BDI-II 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.
次要结局
- Emotional Regulation Questionnaire (ERQ)(12 weeks)
- Penn State Worry Questionnaire-Abbreviated (PSWQ-A)(12 weeks)
- Ruminative Response Scale-10 (RRS-10)(12 weeks)
- Metacognition Questionnaire-30 (MCQ-30)(12 weeks)
研究者
Jorge Corpas López
Clinical Professor
Universidad de Córdoba