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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Wording of the explenation on side-effects as part of the informed consent.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Explanation about common side effects<br>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.<br>* Subjects will hear different versions of the description of SSRI's side-effects and the nocebo effect.<br>|
| Other: Explaning side effects and the nocebo effect<br>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.<br>* Subjects will hear different versions of the description of SSRI's side-effects and the nocebo effect.<br>|
| Other: explanation about the nocebo effect<br>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.<br>* Subjects will hear different versions of the description of SSRI's side-effects and the nocebo effect.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nocebo side-effects SSRI informed consent