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Investigating Hope and Expectations in Open-Label Placebos (I-HELP)

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ClinicalTrials.gov Identifier: NCT03517644
Recruitment Status : Completed
First Posted : May 7, 2018
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Philipps University Marburg Medical Center

Brief Summary:
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 hope and expectations as components of open-label placebos in an experimental study investigating pain..

Condition or disease Intervention/treatment Phase
Pain Other: DP Other: OLP Hope Other: OLP Expectation Other: Placebo cream Other: Heat pain Not Applicable

Detailed 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, research identifying the specific mechanisms underlying OLP is lacking. Therefore, the current study aims to examine hope and expectations as components of OLP in pain.

For this purpose, experimentally induced heat pain is examined. First, all participants receive heat pain stimuli and evaluate them. Next, participants are randomly assigned to one of four groups: (1) a traditional deceptive placebo (DP) group, which is told that they receive an effective analgesic cream, (2) an OLP group inducing hope among the participants that the placebo cream could help them tolerating painful stimuli (OLP hope), (3) and OLP group raising the expectation that the placebo cream will help participants tolerating heat pain (OLP expectation), (4) a control group receiving no cream. Finally, participants receive and evaluate heat pain again.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to one of four experimental groups in parallel for the duration of the study
Masking: Single (Participant)
Masking Description: Using a cover story, participants are instructed to think that there are three experimental groups: a treatment condition, a placebo condition, and a control condition. Therefore, participants from the open-label groups do know that they receive a placebo, but do not know which specific mechanism is being addressed in their condition.
Primary Purpose: Treatment
Official Title: Hope and Expectations as Components of Open-Label Placebos: An Experimental Study Investigating Pain
Actual Study Start Date : February 10, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : August 21, 2018

Arm Intervention/treatment
Experimental: Deceptive Placebo (DP)
After pretreatment heat pain assessment, participants are informed that they are about to receive an effective analgesic cream. In fact, they receive a placebo cream. Next, the posttreatment pain assessment is conducted.
Other: DP
Participants are informed that they are about to receive an effective analgesic cream. They are instructed to apply the cream using a cotton pad.

Other: Placebo cream
The participants receive an inert placebo cream (standard basic cream with oil of thyme produced by a local pharmacy).

Other: Heat pain
Participant receive heat pain stimuli using the suprathreshold method of the Thermo Sensory Analyser (TSA-II), a commonly used device to study pain sensation and analgesic effects.

Experimental: OLP with Hope (OLP Hope)
After pretreatment heat pain assessment, participants are informed that they are about to receive an placebo cream. They are told that the cream has no active pharmacological ingredient. However, using verbal instructions, the investigator aims to induce hope among the participants that the cream could have a positive effect. Next, the posttreatment pain assessment is conducted.
Other: OLP Hope
Participants are informed that they are about to receive an placebo cream. They are told that the cream has no active pharmacological ingredient. Therefore, participants are supposed to evaluate the subjective probability for a positive effect of the cream as rather low. However, using verbal instructions, the investigator aims to induce hope among the participants that the cream could have a positive effect for them because this placebo cream did have a positive among some former participants who were similar to the current participant. The emphasis of this similarity (regarding age and sex) aims to induce a feeling of connectedness to previous participants who reported positive effects of the placebo cream.

Other: Placebo cream
The participants receive an inert placebo cream (standard basic cream with oil of thyme produced by a local pharmacy).

Other: Heat pain
Participant receive heat pain stimuli using the suprathreshold method of the Thermo Sensory Analyser (TSA-II), a commonly used device to study pain sensation and analgesic effects.

Experimental: OLP with Expectations (OLP Expectation)
After pretreatment heat pain assessment, participants are informed that they are about to receive an placebo cream. They are told that the cream has no active pharmacological ingredient. However, using verbal instructions, the investigator aims to raise expectations among the participants that the cream will have a positive effect. Next, the posttreatment pain assessment is conducted.
Other: OLP Expectation
Participants are informed that they are about to receive an placebo cream. They are told that the cream has no active pharmacological ingredient. However, participants are told that placebos have been shown to contribute substantially to clinical outcomes such as pain intensity/unpleasantness. This positive effect of placebos is reasoned by explaining learning mechanisms such as classical conditioning. We anticipated that after hearing this instruction, participants would consider it to be likely that the placebo has a positive effect for them.

Other: Placebo cream
The participants receive an inert placebo cream (standard basic cream with oil of thyme produced by a local pharmacy).

Other: Heat pain
Participant receive heat pain stimuli using the suprathreshold method of the Thermo Sensory Analyser (TSA-II), a commonly used device to study pain sensation and analgesic effects.

Experimental: Control
After pretreatment heat pain assessment, this group does not receive an intervention targeting pain sensation prior to the posttreatment pain assessment.
Other: Heat pain
Participant receive heat pain stimuli using the suprathreshold method of the Thermo Sensory Analyser (TSA-II), a commonly used device to study pain sensation and analgesic effects.




Primary Outcome Measures :
  1. Change in pain intensity scale [ Time Frame: Baseline and 45 minutes ]
    Change in subjective pain intensity assessed using a visual analogue scale (ranging from 0 to 100, with higher values reflecting more pain intensity)


Secondary Outcome Measures :
  1. Change in pain unpleasantness scale [ Time Frame: Baseline and 45 minutes ]
    Change in subjective pain unpleasantness assessed using a visual analogue scale (ranging from 0 to 100, with higher values reflecting more pain unpleasantness)

  2. Change in physiological heat pain threshold [ Time Frame: Baseline and 45 minutes ]
    Change in the individual heat pain threshold (the point when the stimulus changes from being warm to being painful)

  3. Change in physiological heat pain tolerance [ Time Frame: Baseline and 45 minutes ]
    Change in the individual heat pain tolerance (the point when participants cannot stand the heat pain stimulus any longer)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • sufficient German language knowledge
  • at least 18 years old

Exclusion Criteria:

  • current mental disorder
  • current medical disease
  • studying psychology or medicine
  • pregnancy or breastfeeding period
  • intake of drugs
  • severely visually impaired

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03517644


Locations
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Germany
Philipps-University of Marburg
Marburg, Hessen, Germany, 35037
Sponsors and Collaborators
Philipps University Marburg Medical Center
Investigators
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Principal Investigator: Tobias Kube, M. Sc. Philipps University Marburg Medical Center

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Responsible Party: Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT03517644     History of Changes
Other Study ID Numbers: 2017-58v
First Posted: May 7, 2018    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs