NCT01200615

The Nocebo Effect: a Prospective Study of Informed Consent as a Factor in the Prevalence of SSRI's Side Effects

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Shalvata Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 66 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: 1. 50 patients started on SSRI's will be updated about its common side effects 2. 50 patients started on SSRI's will be updated about its common side effects and will receive an explenation on 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. 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).

Conditions

• Depression

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-10-01
• Completion: 2013-10-01
• First posted: 2010-09-13
• Last updated: 2010-09-13

Locations

1 site across 1 country: Israel