Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To date, very little is known about the mechanisms of open-label placebo treatment and there is a lack in highly controlled experimental designs. Therefore, the planned project will test well-established explanatory models of (deceptive) placebo, i.e., (1) expectancy, (2) meaning response, in an open-label placebo design, investigating their influence on placebo analgesia.
The current project will consist of one experimental study and one qualitative study:
The experimental study will be a randomized experiment with healthy subjects (N=120), and pain will be induced using a standardized heat pain paradigm (Medoc, Ramatishai, Israel; thermo-sensory analyzer (TSA)-II). Effects of the experimental conditions will be assessed both objectively (i.e. heat pain threshold and tolerance) and subjectively (i.e. subjective pain ratings, pain intensity and unpleasantness). Furthermore, investigators will randomly select 30 participants to take part in a nested qualitative study in order to qualitatively assess the meaning response by comparing subjective narratives of the placebo effect in the open-label and deceptive placebo groups, as well as in the control group.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open-label placebo | Placebo Comparator | Participants (N=40) will have the information that they are receiving an inert cream (i.e. "placebo"). Placebo will be described as an inert or inactive cream, with no medication in it. Additionally, participants will be told that "placebo has been shown in rigorous clinical testing to produce significant mind-body self-healing processes." The placebo administration will be combined with the following scientific rationale/verbal suggestion: (a) placebos are effective analgesics, (b) classical conditioning as a possible mechanism of this effect, (c) compliance is important for outcome and (d) positive expectations increase placebo effects, but are not necessary. |
|
| deceptive placebo | Sham Comparator | Participants (N=40) will have the information that they are receiving an analgesic cream ("Antidolor, containing "Lidocain"), while in fact they will receive an inert cream, only. Antidolor will be described as an analgesic cream. |
|
| control group | Placebo Comparator | Participants (N=40) will have the information that they are receiving an inert control cream. |
|
| no treatment group | No Intervention | Participants (N=40) will be told that they are in the "no treatment group" and that they will not receive an analgesic cream. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| open-label placebo | Other | Placebo Cream, openly described as "Placebo" |
|
| Measure | Description | Time Frame |
|---|---|---|
| subjective intensity and unpleasantness ratings of heat pain tolerance | Visual Analogue Scale (VAS) | 2 hours |
| objective heat pain tolerance | Temperatures | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Expectancy of Relief Scale (ERS; Erwartungsfragebogen) | 2 hours | |
| Credibility and Effectiveness of the placebo analgesia expectation; adapted Version of the Context Model Questionnaire; Kontextmodellfragebogen (KMF) | 2 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jens Gaab, Prof | Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Basel | Basel | 4055 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34408060 | Derived | Locher C, Buergler S, Frey Nascimento A, Kost L, Blease C, Gaab J. Lay perspectives of the open-label placebo rationale: a qualitative study of participants in an experimental trial. BMJ Open. 2021 Aug 18;11(8):e053346. doi: 10.1136/bmjopen-2021-053346. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| deceptive placebo | Other | Placebo Cream, described as "Voltaren, containing Diclofenac" |
|
| multidimensional sensitivities questionnaire (Mehrdimensionaler Befindlichkeitsfragebogen (MDBF)) | 2 hours |
| sociodemographic questionnaire (Soziodemographischer Fragebogen (SDD)) | 2 hours |
| Revised Life Orientation Test (LOT-R) | 2 hours |
| NEO five-factor inventory (NEO-FFI) | 2 hours |
| questionnaire on competence and locus of control (Fragebogen zu Kompetenz- und Kontrollüberzeugungen (FKK)) | 2 hours |
| Anxiety and Depression Scale (HADS-D) | 2 hours |
| Beliefs in holistic health and holistic treatments; Complementary and Alternative Medicine Beliefs Intentory (CAMBI) | 2 hours |
| Desire for Relief Scale (DRS) | 2 hours |
| subjective intensity and unpleasantness ratings of heat pain threshold | Visual Analogue Scale (VAS) | 2 hours |
| objective heat pain threshold | Temperatures | 2 hours |