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

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Wording of the explenation on side-effects as part of the informed consent.
Sponsored by
Shalvata Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring nocebo side-effects SSRI informed consent

Eligibility Criteria

18 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shalvata Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Explanation about common side effects

Explaning side effects and the nocebo effect

explanation about the nocebo effect

Arm Description

50 patients started on SSRI's will be updated about its common side effects

subjects started on SSRI's will be updated about its common side effects and 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 26, 2010
Last Updated
September 10, 2010
Sponsor
Shalvata Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT01200615
Brief Title
The Nocebo Effect: a Prospective Study of Informed Consent as a Factor in the Prevalence of SSRI's Side Effects
Official Title
The Nocebo Effect: a Prospective Study of Informed Consent as a Factor in the Prevalence of SSRI's Side Effects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
October 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shalvata Mental Health Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
nocebo side-effects SSRI informed consent

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Explanation about common side effects
Arm Type
Other
Arm Description
50 patients started on SSRI's will be updated about its common side effects
Arm Title
Explaning side effects and the nocebo effect
Arm Type
Other
Arm Description
subjects started on SSRI's will be updated about its common side effects and the nocebo effect
Arm Title
explanation about the nocebo effect
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Wording of the explenation on side-effects as part of the informed consent.
Intervention Description
Subjects will hear different versions of the description of SSRI's side-effects and the nocebo effect.
Primary Outcome Measure Information:
Title
The prevalence of side-effects
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uri Nitzan, MD
Organizational Affiliation
Shalvata Mental Health Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shalvata Mental Health Center
City
Hod Hasharon
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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