The Nocebo Effect: a Prospective Study of Informed Consent as a Factor in the Prevalence of SSRI's Side Effects
研究概览
详细说明
In this study the investigators wish to inquire whether the nature of the explenation given to the patient as part of informed consent has an effect on the prevalence of side-effects. The study will take place in the out-patient clinic at the Shalvata Mental health Center. Three arms are included:
- 50 patients started on SSRI's will be updated about its common side effects
- 50 patients started on SSRI's will be updated about its common side effects and will receive an explenation on the nocebo effect
- 50 patients started on SSRI's will receive an explenation on the nocebo effect, but will not be updated about common side-effects. Nonetheless, they will be informed of severe side-effects.
Following the prescription of an SSRI the subjects will we enter the follow-up phase of the study. They will attend two follow-up meetings: 3 days after the initiation point and one month after the starting point. During each meeting they will be asked to fill the Antidepressant Side-Effect Checklist (ASEC)and the General Health Questionnaire (GHQ).
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
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Hod Hasharon、以色列
- Shalvata Mental Health Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- age 18-60
- started on an SSRI
Exclusion Criteria:
- Psychotic spectrum disorder
- Suicidality
- Sensitivity to SSRI
- Has taken the prescribed SSRI in the past
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:阶乘赋值
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他:Explanation about common side effects
50 patients started on SSRI's will be updated about its common side effects
|
Subjects will hear different versions of the description of SSRI's side-effects and the nocebo effect.
|
|
其他:Explaning side effects and the nocebo effect
subjects started on SSRI's will be updated about its common side effects and the nocebo effect
|
Subjects will hear different versions of the description of SSRI's side-effects and the nocebo effect.
|
|
其他:explanation about the nocebo effect
3. 50 patients started on SSRI's will receive an explenation on the nocebo effect, but will not be updated about common side-effects.
Nonetheless, they will be informed of severe side-effects.
|
Subjects will hear different versions of the description of SSRI's side-effects and the nocebo effect.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The prevalence of side-effects
大体时间:6 weeks
|
We are interested in the possible influence of the physicians wording upon recieving informed consend from the patient and the prevalence of side-effects
|
6 weeks
|
合作者和调查者
调查人员
- 首席研究员:Uri Nitzan, MD、Shalvata Mental Health Center
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
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