Components of Placebo Effects in Sadness
Raktažodžiai
Santrauka
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
Intervencija / gydymas
Other: OLP scientifically-objective
Other: OLP personally-affective
Other: DP scientifically-objective
Other: DP personally-affective
Fazė
Rankų grupės
Ranka | Intervencija / 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 lytys | All |
Priima sveikus savanorius | Taip |
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]