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

Not Applicable

• Conditions: Depression
• Interventions: Behavioral: Wording of the explenation on side-effects as part of the informed consent.

• Registration Number: NCT01200615
• Lead Sponsor: Shalvata Mental Health Center

Brief 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).

Study Timeline

• Study First Submitted: 2010-08-26
• Status Verified: 2010-09
• Study First Submitted QC: 2010-09-10
• Last Update Submitted: 2010-09-10
• Study First Posted: 2010-09-13
• Last Update Posted: 2010-09-13
• Study Start: 2010-10
• Primary Completion: 2012-10
• Study Completion: 2013-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. age 18-60
2. started on an SSRI

Exclusion Criteria

• Psychotic spectrum disorder
• Suicidality
• Sensitivity to SSRI
• Has taken the prescribed SSRI in the past

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Explanation about common side effects	Wording of the explenation on side-effects as part of the informed consent.	50 patients started on SSRI's will be updated about its common side effects
Explaning side effects and the nocebo effect	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
explanation about the nocebo effect	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.

Primary Outcome Measures

Name	Time	Method
The prevalence of side-effects	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

Trial Locations

Locations (1)

Shalvata Mental Health Center; 🇮🇱 Hod Hasharon, Israel