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Components of Placebo Effects in Sadness

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Rėmėjai
Philipps University Marburg Medical Center

Raktažodžiai

Santrauka

Research has shown that placebo effects contribute substantially to clinical outcomes. Recent evidence suggests that placebos remain effective even if they are openly described as placebos (so-called Open-Label Placebos). In this study, the investigators examine components of open-label placebos and traditional deceptive placebos in an experimental study investigating sadness.

apibūdinimas

A growing body of research has indicated that placebos contribute substantially to clinical outcomes. Yet, the implementation of deceptive placebos in clinical practice is incompatible with key principles of openness and patient autonomy. However, recent research suggests that placebos remain effective even if they openly described as placebos (so-called Open-Label Placebos (OLP)), hence questioning the necessity of deception in clinical trials.

However, comparisons between OLP and deceptive placebos (DP) with regard to their particular mechanisms are lacking. Therefore, the current study aims to identify components of OLP and DP. For this purpose, experimentally induced sadness is examined using a standardized paradigm which has previously been developed by our working group. In particular, healthy volunteers are informed that a new application method for a well-known antidepressant would be tested. Sadness is assessed before and after receiving a nasal spray. Two experimental groups (DP groups) are informed that they would receive an antidepressant nasal spray, another two experimental groups (OLP groups) are informed that they would receive a placebo. In fact, all nasal sprays are active placebos inducing prickling nasal sensations (sesame oil with 0.014% capsaicin). In addition to the factor "Transparency" (DP vs. OLP), the instruction is experimentally varied, with which the substance is administered (scientifically-objective vs. personally-affective), resulting in a 2x2 design. Further, there is an additional fifth group receiving no intervention. The primary outcome is self-rated sadness after taking the nasal spray.

Datos

Paskutinį kartą patikrinta: 11/30/2018
Pirmasis pateikimas: 03/06/2018
Numatytas registravimas pateiktas: 04/23/2018
Pirmas paskelbtas: 04/24/2018
Paskutinis atnaujinimas pateiktas: 12/17/2018
Paskutinis atnaujinimas paskelbtas: 12/18/2018
Faktinė studijų pradžios data: 03/14/2018
Numatoma pirminio užbaigimo data: 06/29/2019
Numatoma studijų užbaigimo data: 10/30/2019

Būklė ar liga

Dysphoric Mood

Intervencija / gydymas

Other: OLP scientifically-objective

Other: OLP personally-affective

Other: DP scientifically-objective

Other: DP personally-affective

Fazė

-

Rankų grupės

RankaIntervencija / gydymas
Experimental: OLP scientifically-objective
Participants are informed that they are about to take a placebo. The rationale for the effectivity of placebos is explained in a scientifically-objective manner.
Other: OLP scientifically-objective
Participants are informed that they are about to take a placebo. The rationale for the effectivity of placebos is explained in a scientifically-objective manner.
Experimental: OLP personally-affective
Participants are informed that they are about to take a placebo. The rationale for the effectivity of placebos is explained in a personally-affective manner.
Other: OLP personally-affective
Participants are informed that they are about to take a placebo. The rationale for the effectivity of placebos is explained in a personally-affective manner.
Experimental: DP scientifically-objective
Participants are informed that they are about to take an effective antidepressant. The rationale for the effectivity of the antidepressant is explained in a scientifically-objective manner.
Other: DP scientifically-objective
Participants are informed that they are about to take an effective antidepressant. The rationale for the effectivity of the antidepressant is explained in a scientifically-objective manner.
Experimental: DP personally-affective
Participants are informed that they are about to take an effective antidepressant. The rationale for the effectivity of the antidepressant is explained in a personally-affective manner.
Other: DP personally-affective
Participants are informed that they are about to take an effective antidepressant. The rationale for the effectivity of the antidepressant is explained in a personally-affective manner.
No Intervention: Control group
This group does not take the nasal spray.

Tinkamumo kriterijai

Amžius, tinkami studijuoti 18 Years Į 18 Years
Tinkamos studijoms lytysAll
Priima sveikus savanoriusTaip
Kriterijai

Inclusion Criteria:

- age between 18 and 40 years

- no mental disorder or physical disease

- sufficient German language knowledge

Exclusion Criteria:

- intake of psychopharmacological drugs

- intake of illegal drugs in the last two weeks

- consumption of alcohol in the last twelve hours

- allergy to capsaicin or sesame

Rezultatas

Pirminės rezultatų priemonės

1. Change in Positive and Negative Affect Schedule (PANAS) [Baseline and 45 minutes]

Change of self-rated sadness

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