An interventional study of Wording of the explenation on side-effects as part of the informed consent. in Depression, sponsored by Shalvata Mental Health Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 66 Years. Per ClinicalTrials.gov, last updated 2010-09-13.
Sponsored by Shalvata Mental Health Center · Not applicable, Interventional, and Prevention
In this study we invetigate the influence of the nocebo effect (as part of obtaining informed consent) on the prevalence of side-effects. The study is prospective, focusing on the connection between what the physicians says to the patient about side-effects to the frequency of these side effects during treatment period. We also inquire whether informing the patient about the existence of the nocebo effect influences the extent of phenomena.
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:
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).
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 150 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Shalvata Mental Health Center is the lead sponsor of 73 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
50 patients started on SSRI's will be updated about its common side effects
Behavioral: Wording of the explenation on side-effects as part of the informed consent.
subjects started on SSRI's will be updated about its common side effects and the nocebo effect
Behavioral: Wording of the explenation on side-effects as part of the informed consent.
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.
Behavioral: Wording of the explenation on side-effects as part of the informed consent.
Subjects will hear different versions of the description of SSRI's side-effects and the nocebo effect.
The prevalence of side-effects
We are interested in the possible influence of the physicians wording upon recieving informed consend from the patient and the prevalence of side-effects
Time frame: 6 weeks
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Shalvata Mental Health Center