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

Shalvata Mental Health Center

Status: Unknown

Conditions: Depression

Treatments: Behavioral: Wording of the explenation on side-effects as part of the informed consent.

Study type: Interventional

Funder types: Other

Identifiers

NCT01200615

025622648

Details and patient eligibility

About

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.

Full 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).

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 66 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Explanation about common side effects

Other group

Description:

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

Treatment:

Behavioral: Wording of the explenation on side-effects as part of the informed consent.

Explaning side effects and the nocebo effect

Other group

Description:

subjects started on SSRI's will be updated about its common side effects and the nocebo effect

Treatment:

Behavioral: Wording of the explenation on side-effects as part of the informed consent.

explanation about the nocebo effect

Other group

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.

Treatment:

Behavioral: Wording of the explenation on side-effects as part of the informed consent.