Components of Placebo Effects in Sadness (COPES)

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Philipps University

Status

Completed

Conditions

Dysphoric Mood

Treatments

Other: OLP scientifically-objective
Other: DP scientifically-objective
Other: OLP personally-affective
Other: DP personally-affective

Study type

Interventional

Funder types

Other

Identifiers

NCT03507959
2017-40v

Details and patient eligibility

About

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.

Full description

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.

Enrollment

159 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

159 participants in 5 patient groups

OLP scientifically-objective
Experimental group
Description:
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.
Treatment:
Other: OLP scientifically-objective
OLP personally-affective
Experimental group
Description:
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.
Treatment:
Other: OLP personally-affective
DP scientifically-objective
Experimental group
Description:
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.
Treatment:
Other: DP scientifically-objective
DP personally-affective
Experimental group
Description:
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.
Treatment:
Other: DP personally-affective
Control group
No Intervention group
Description:
This group does not take the nasal spray.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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