Back to Basics - Effects, Narratives and Routes of Administration of Open-label Placebo

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.

Study Overview

• Status: Completed
• Conditions: Pain; Placebo Effect; Expectancy
• Intervention / Treatment: Other: open-label placebo; Other: deceptive placebo

Detailed Description

The current project will consist of one experimental study and one qualitative study:

1. the effects of open-label, and deceptive placebo administration on placebo analgesia will be directly compared when both groups have a comparable expectancy-inducing scientific rationale;
2. subjective meaning models will be assessed by comparing subjective narratives of the placebo effect in open-label and deceptive placebo groups in a nested 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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4055
    • University of Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male and female adults aged 18-65
• Healthy by self-report statement, thus no known current or chronic somatic diseases or psychiatric disorders
• Right-handedness (Oldfield, 1971),
• Willing to participate in study

Exclusion Criteria:

• Medicine or Psychology Students
• Any acute or chronic disease (chronic pain, hypertension, heart disease, renal disease, liver disease, diabetes) as well as skin pathologies, neuropathies or nerve entrapment symptoms, sensory abnormalities affecting the tactile or thermal modality
• Current medications (psychoactive medication, narcotics, intake of analgesics) or being currently in psychological or psychiatric treatment
• Insufficient German language skills to understand the instructions
• Previous participation in studies using pain assessment (threshold and tolerance) with Peltier Devices
• Daily consumption of more than three alcoholic standard beverages per day (a standard alcoholic beverage is defined as either 3dl beer or 1 dl wine or 2cl spirits)
• Current or regular drug consumption (THC, cocaine, heroin, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: open-label placebo; 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.	Other: open-label placebo; Placebo Cream, openly described as "Placebo"
Sham Comparator: deceptive placebo; 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.	Other: deceptive placebo; Placebo Cream, described as "Voltaren, containing Diclofenac"
Placebo Comparator: control group; Participants (N=40) will have the information that they are receiving an inert control cream.	Other: open-label placebo; Placebo Cream, openly described as "Placebo"
No Intervention: no treatment group; Participants (N=40) will be told that they are in the "no treatment group" and that they will not receive an analgesic cream.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Study Chair: Jens Gaab, Prof, Clinical Psychology and Psychotherapy, Department of Psychology, University of Basel

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: October 12, 2015
• First Submitted That Met QC Criteria: October 14, 2015
• First Posted (Estimate): October 19, 2015

Study Record Updates

• Last Update Posted (Actual): July 26, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: EKNZ 2015-246