PlaceboNCT05425563
Effects of Expectations on Negative Affect, Perceived Cognitive Effort, and Pain
A study testing Pain Expectancy Cues, Vicarious Pain Expectancy Cues and Cognitive Effort Expectancy Cues in people with Placebo and Expectations, run by Trustees of Dartmouth College at 1 site in United States.
Trial summary
The investigators administer a functional neuroimaging task to investigate the effect of cue expectancy on participants' self-reported ratings across a variety of affective and cognitive domains. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Placebo, Expectations
- What is being tested?
- Pain Expectancy Cues, Vicarious Pain Expectancy Cues and Cognitive Effort Expectancy Cues
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2020to 19 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Capable of performing experimental tasks (e.g., are able to read, can tolerate the maximum level of thermal pain stimuli).
- Fluent or native speakers of English
Who cannot join
- Contraindications to magnetic resonance scanning (e.g., metal in body, claustrophobia, pregnancy)
- Substance abuse within the last six months
- Current or recent history of pathological pain
- Current or recent history of neurological disorders
- Currently or recent history of chronic pain
- Left-handed only
Trial locations and contacts
1 site in 1 country.
About this study
The investigators administer a functional neuroimaging task to investigate the effect of cue expectancy on participants' self-reported ratings across a variety of affective and cognitive domains. The experiment incorporates three tasks in which participants experience and rate 1) somatic pain, 2) vicarious pain, and 3) cognitive effort. In the somatic pain task, participants receive a brief thermal stimulus administered to a site on their arm; in the vicarious pain task, participants watch a short video clip of a patient with back/shoulder pain; in the cognitive effort task, participants perform a cognitively demanding "mental rotation" task that requires them to indicate whether two 3D objects are the same or different when rotated along the y-axis. Each trial follows a sequence that begins with a fixation, followed by a social influence cue, then an expectation rating, followed by a condition-specific stimulus, and then, an actual rating of the outcome experience.
There are four events of interest: 1) cue perception, 2) expectation rating, 3) stimulus experience, and 4) outcome rating.
First, participants are presented with a cue that depicts how other participants responded to the upcoming stimulus ("cue perception"). Although the participant is told these are real ratings, they are in fact, fabricated data points that vary in intensity (low, high). Then, based on the provided cues, participants are prompted to report their expectation of the upcoming stimulus intensity ("expectation rating") After providing an expectation rating, participants are presented with a condition-specific stimulus (somatic pain, vicarious pain, or cognitive effort) that also varies in three levels of low, medium, high stimulus intensity ("stimulus experience"). Once the stimulus presentation has concluded, participants are prompted to provide an actual rating of their experience ("outcome rating"). For the somatic pain condition, participants rate their expectations and actual experience of how painful the stimulus was; for the vicarious pain condition, they rate their expectations and actual perception of how much pain the patient was in; and for the cognitive condition, the participant provides expectation and actual ratings of task difficulty.
- Conditions
- Placebo, Expectations
- Being tested
- Pain Expectancy Cues, Vicarious Pain Expectancy Cues, Cognitive Effort Expectancy Cues
- Keywords
- Social Placebo, Somatic Pain, Vicarious Pain, Cognitive Effort
- Medical subject headings
- Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Expectancy CuesBehavioural
Participants are presented with a social cue that represents how previous participants responded to the upcoming somatic pain stimulus. In actuality, the cue is a social placebo, constructed by the experimenters and varying in intensity.
Vicarious Pain Expectancy CuesBehavioural
Participants are presented with a social cue that represents how previous participants responded to the upcoming vicarious pain stimulus. In actuality, the cue is a social placebo, constructed by the experimenters and varying in intensity.
Cognitive Effort Expectancy CuesBehavioural
Participants are presented with a social cue that represents how previous participants responded to the upcoming cognitive effort stimulus. In actuality, the cue is a social placebo, constructed by the experimenters and varying in intensity.
| Study group | Role | What they receive |
|---|---|---|
| Cue-established expectations | Experimental | Prior to experiencing the stimuli from three tasks (somatic pain/cognitive effort/vicarious pain), the participant is presented with an expectancy cue. The cue depicts 10 data points on a semi-circular scale (0-180 degrees) with categorical labels ranging from "no effort" to "strongest effort of any kind." Subsequently, participants report expectation ratings and outcome ratings. Receives: Behavioral: Pain Expectancy Cues; Behavioral: Vicarious Pain Expectancy Cues; Behavioral: Cognitive Effort Expectancy Cues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral: Within Participant Subjective Outcome Ratings of Acute Thermal Pain Following High Compared to Low Cues
The outcome measure is the "subjective outcome rating" for perceived pain. In each session, participants undergo pain tasks with multiple thermal stimuli. After each stimulus, participants rate their perceived pain on a semi-circular scale (0-180°). Higher angles indicate greater perceived pain. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average rating after high cue and after low cue. The final outcome is the difference between these averages, forming a contrast score that reflects the average difference in perceived pain as a function of high and low cue exposure.
- Scale: 0-180°
- Min value: 0
- Max value: 180
- Higher scores indicate heightened pain perception.
Measured: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, and contrasted to a single outcome measure: perceived pain as a function of high low cue exposure.
Behavioral: Within Participant Subjective Outcome Ratings of Vicarious Pain Following High Compared to Low Cues
The outcome measure is the "subjective outcome rating" for perceived vicarious pain. In each session, participants undergo vicarious pain tasks, watching multiple videos of patients in pain. After each stimulus, participants rate their perceived vicarious pain on a semi-circular scale (0-180°). Higher angles indicate that participants perceived greater pain for the patient in video. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average outcome rating after high cue and after low cue. The final outcome is the difference between these averages, forming a contrast score that reflects the average difference in perceived vicarious pain as a function of high and low cue exposure.
- Scale: 0-180°
- Min value: 0
- Max value: 180
- Higher scores indicate heightened perception of vicarious pain.
Measured: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, and contrasted to a single outcome measure: perceived vicarious pain as a function of high low cue exposure.
Behavioral: Within Participant Subjective Ratings of Cognitive Effort Following High Compared to Low Cues
The outcome measure is the "subjective outcome rating" for cognitive effort. In each session, participants undergo cognitive effort task where images of mentally rotated figures are presented. After each stimulus, participants rate their perceived cognitive effort on a semi-circular scale (0-180°). Higher angles indicate greater perceived of cognitive effort. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average outcome rating after high cue and after low cue. The final outcome is the difference between these averages, forming a contrast score that reflects the average difference in perceived cognitive effort as a function of high and low cue exposure.
- Scale: 0-180°
- Min value: 0
- Max value: 180
- Higher scores indicate heightened perception of cognitive effort..
Measured: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, and contrasted to a single outcome measure: perceived cognitive effort as a function of high low cue exposure.
Behavioral: Within Participant Subjective Outcome Ratings of Acute Thermal Pain Following High Cues
This outcome measure is the least metabolized data of "subjective outcome rating" for perceived pain. In each session, participants undergo pain tasks with multiple thermal stimuli. After each stimulus, participants rate their perceived pain on a semi-circular scale (0-180°). Higher angles indicate greater perceived pain. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average rating after high cue and after low cue. Reported here is the average subjective outcome rating, post-high cue.
- Scale: 0-180°
- Min value: 0
- Max value: 180
- Higher scores indicate heightened pain perception.
Measured: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of high cue exposure.
Behavioral: Within Participant Subjective Outcome Ratings of Acute Thermal Pain Following Low Cues
This outcome measure is the least metabolized data of "subjective outcome rating" for perceived pain. In each session, participants undergo pain tasks with multiple thermal stimuli. After each stimulus, participants rate their perceived pain on a semi-circular scale (0-180°). Higher angles indicate greater perceived pain. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average rating after high cue and after low cue. Reported here is the average subjective outcome rating post-low cue.
- Scale: 0-180°
- Min value: 0
- Max value: 180
- Higher scores indicate heightened pain perception.
Measured: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of low cue exposure.
Behavioral: Within Participant Subjective Outcome Ratings of Vicarious Pain Following High Cues
The outcome measure is the least metabolized data of "subjective outcome rating" for perceived vicarious pain. In each session, participants undergo vicarious pain tasks, watching multiple videos of patients in pain. After each stimulus, participants rate their perceived vicarious pain on a semi-circular scale (0-180°). Higher angles indicate that participants perceived greater pain for the patient in video. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average outcome rating after high cue and after low cue. Reported here is the average subjective outcome rating post high cue.
- Scale: 0-180°
- Min value: 0
- Max value: 180
- Higher scores indicate heightened perception of vicarious pain.
Measured: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of high cue exposure.
Behavioral: Within Participant Subjective Outcome Ratings of Vicarious Pain Following Low Cues
The outcome measure is the least metabolized data of "subjective outcome rating" for perceived vicarious pain. In each session, participants undergo vicarious pain tasks, watching multiple videos of patients in pain. After each stimulus, participants rate their perceived vicarious pain on a semi-circular scale (0-180°). Higher angles indicate that participants perceived greater pain for the patient in video. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average outcome rating after high cue and after low cue. Reported here is the average subjective outcome rating post low cue.
- Scale: 0-180°
- Min value: 0
- Max value: 180
- Higher scores indicate heightened perception of vicarious pain.
Measured: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of low cue exposure.
Behavioral: Within Participant Subjective Ratings of Cognitive Effort Following High Cues
The outcome measure is the least metabolized data of "subjective outcome rating" for cognitive effort. In each session, participants undergo cognitive effort task where images of mentally rotated figures are presented. After each stimulus, participants rate their perceived cognitive effort on a semi-circular scale (0-180°). Higher angles indicate greater perceived of cognitive effort. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average outcome rating after high cue and after low cue. Reported here is the average subjective outcome rating post high cue.
- Scale: 0-180°
- Min value: 0
- Max value: 180
- Higher scores indicate heightened perception of cognitive effort.
Measured: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of high cue exposure.
Behavioral: Within Participant Subjective Ratings of Cognitive Effort Following Low Cues
The outcome measure is the least metabolized data of "subjective outcome rating" for cognitive effort. In each session, participants undergo cognitive effort task where images of mentally rotated figures are presented. After each stimulus, participants rate their perceived cognitive effort on a semi-circular scale (0-180°). Higher angles indicate greater perceived of cognitive effort. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average outcome rating after high cue and after low cue. Reported here is the average subjective outcome rating post low cue.
- Scale: 0-180°
- Min value: 0
- Max value: 180
- Higher scores indicate heightened perception of cognitive effort.
Measured: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of low cue exposure.
Secondary outcomes (13)
Behavioral: Within Participant Expectation Ratings of Acute Thermal Pain Following High Compared to Low Cues
The outcome measure is the "expectation rating" for upcoming pain. In each session, participants undergo pain tasks with multiple thermal stimuli. Before each stimulus, participants see a high or low cue and rate their pain expectation on a semi-circular scale (0-180°). Higher angles indicate greater pain expectations. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average rating after high cue and after low cue. The final outcome is the difference between these averages, forming a contrast score that reflects the variance in pain expectations between cues.
- Scale: 0-180°
- Min value: 0
- Max value: 180
- Higher scores indicate heightened expectations for thermal pain intensity.
Measured: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, and contrasted to a single outcome measure: expectations of pain as a function of high low cue exposure.
Behavioral: Within Participant Expectation Ratings of Vicarious Pain Following High Compared to Low Cues
The outcome measure is the "expectation rating" for upcoming vicarious pain. In each session, participants undergo vicarious pain tasks, watching multiple videos of patients in pain. Prior to each stimulus, participants see a high or low cue and rate their expectation of perceived vicarious pain for an upcoming stimulus experience on a semi-circular scale (0-180°). Higher angles suggest participants anticipate viewing videos of patients experiencing greater pain. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average expectation rating after high cue and after low cue. The final outcome is the difference between these averages, forming a contrast score that reflects difference in vicarious pain expectations between cues.
- Scale: 0-180°
- Min value: 0
- Max value: 180
- Higher scores indicate heightened expectations for vicarious pain intensity.
Measured: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, and contrasted to a single outcome measure: expectations of vicarious pain as a function of high low cue exposure.
Behavioral: Within Participant Expectation Ratings of Cognitive Effort Following High Compared to Low Cues
The outcome measure is the "expectation rating" for upcoming cognitive effort. In each session, participants undergo cognitive effort tasks where images of mentally rotated figures are presented. Before each stimulus, participants see a high or low cue and rate their expectations on cognitive effort on a semi-circular scale (0-180°). Higher angles indicate greater expectations of cognitive effort. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average expectation rating after high cue and after low cue. The final outcome is the difference between these averages, forming a contrast score that reflects the difference in cognitive effort expectations between cues.
- Scale: 0-180°
- Min value: 0
- Max value: 180
- Higher scores indicate heightened expectations of cognitive effort.
Measured: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, and contrasted to a single outcome measure: expectations of cognitive effort as a function of high low cue exposure.
Behavioral: Within Participant Expectations Ratings of Acute Thermal Pain Following High Cues
The outcome measure is the least metabolized data of "expectation rating" for upcoming pain. In each session, participants undergo pain tasks with multiple thermal stimuli. Before each stimulus, participants see a high or low cue and rate their pain expectation on a semi-circular scale (0-180°). Higher angles indicate greater pain expectations. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average rating after high cue and after low cue. Reported here is the average expectation rating, post-high cue.
- Scale: 0-180°
- Min value: 0
- Max value: 180
- Higher scores indicate heightened expectations for thermal pain intensity.
Measured: Within trials, outcome ratings are collected pre-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, and contrasted to a single outcome measure: expectations of pain as a function of high cue exposure.
Behavioral: Within Participant Expectations Ratings of Acute Thermal Pain Following Low Cues
The outcome measure is the least metabolized data of "expectation rating" for upcoming pain. In each session, participants undergo pain tasks with multiple thermal stimuli. Before each stimulus, participants see a high or low cue and rate their pain expectation on a semi-circular scale (0-180°). Higher angles indicate greater pain expectations. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average rating after high cue and after low cue. Reported here is the average expectation rating, post-low cue.
- Scale: 0-180°
- Min value: 0
- Max value: 180
- Higher scores indicate heightened expectations for thermal pain intensity.
Measured: Within trials, outcome ratings are collected pre-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, and contrasted to a single outcome measure: expectations of pain as a function of low cue exposure.
Behavioral: Within Participant Expectation Ratings of Vicarious Pain Following High Cues
The outcome measure is the least metabolized data of "expectation rating" for upcoming vicarious pain. In each session, participants undergo vicarious pain tasks, watching multiple videos of patients in pain. Prior to each stimulus, participants see a high or low cue and rate their expectation of perceived vicarious pain for an upcoming stimulus experience on a semi-circular scale (0-180°). Higher angles suggest participants anticipate viewing videos of patients experiencing greater pain. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average expectation rating after high cue and after low cue. Reported here is the average expectation rating, post-high cue.
- Scale: 0-180°
- Min value: 0
- Max value: 180
- Higher scores indicate heightened expectations for vicarious pain intensity.
Measured: Within trials, outcome ratings are collected pre-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting perceived vicarious pain as a function of high cue exposure.
Behavioral: Within Participant Expectation Ratings of Vicarious Pain Following Low Cues
The outcome measure is the least metabolized data of "expectation rating" for upcoming vicarious pain. In each session, participants undergo vicarious pain tasks, watching multiple videos of patients in pain. Prior to each stimulus, participants see a high or low cue and rate their expectation of perceived vicarious pain for an upcoming stimulus experience on a semi-circular scale (0-180°). Higher angles suggest participants anticipate viewing videos of patients experiencing greater pain. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average expectation rating after high cue and after low cue. Reported here is the average expectation rating, post-low cue.
- Scale: 0-180°
- Min value: 0
- Max value: 180
- Higher scores indicate heightened expectations for vicarious pain intensity.
Measured: Within trials, outcome ratings are collected pre-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting perceived vicarious pain as a function of low cue exposure.
Behavioral: Within Participant Expectation Ratings of Cognitive Effort Following High Cues
The outcome measure is the least metabolized data of "expectation rating" for upcoming cognitive effort. In each session, participants undergo cognitive effort tasks where images of mentally rotated figures are presented. Before each stimulus, participants see a high or low cue and rate their expectations on cognitive effort on a semi-circular scale (0-180°). Higher angles indicate greater expectations of cognitive effort. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average expectation rating after high cue and after low cue. Reported here is the average expectation rating, post-high cue.
- Scale: 0-180°
- Min value: 0
- Max value: 180
- Higher scores indicate heightened expectations for cognitive effort.
Measured: Within trials, outcome ratings are collected pre-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of high cue exposure.
Behavioral: Within Participant Expectation Ratings of Cognitive Effort Following Low Cues
The outcome measure is the least metabolized data of "expectation rating" for upcoming cognitive effort. In each session, participants undergo cognitive effort tasks where images of mentally rotated figures are presented. Before each stimulus, participants see a high or low cue and rate their expectations on cognitive effort on a semi-circular scale (0-180°). Higher angles indicate greater expectations of cognitive effort. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average expectation rating after high cue and after low cue. Reported here is the average expectation rating, post-low cue.
- Scale: 0-180°
- Min value: 0
- Max value: 180
- Higher scores indicate heightened expectations for cognitive effort.
Measured: Within trials, outcome ratings are collected pre-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of low cue exposure.
Physiological: Within Participant Changes in Skin Conductance Response Measured With a Physiological Data Acquisition Device
Each session of the experiment includes somatic pain, vicarious pain, cognitive effort tasks, in which multiple stimuli are delivered. Skin conductance response will be measured continuously, using a physiological data acquisition device, "Biopac MP150". The investigators will compare the skin conductance rate in response to stimuli delivery as a function high vs. low cue presentation.
Measured: Measured continuously during each task, concurrent with stimulus delivery. Each task is distributed across 3 sessions. Within each task, we plan to average skin conductance rate across sessions.
Physiological: Within Participant Changes in Skin Conductance Rate Measured With a Physiological Data Acquisition Device
Each session of the experiment includes somatic pain, vicarious pain, cognitive effort tasks, in which multiple stimuli are delivered. Skin conductance rate will be measured continuously, using a physiological data acquisition device, "Biopac MP150". The investigators will compare the skin conductance rate in response to stimuli delivery as a function high vs. low cue presentation.
Measured: Measured continuously during each task, concurrent with stimulus delivery. Each task is distributed across 3 sessions. Within each task, we plan to average skin conductance rate across sessions.
Functional Magnetic Resonance Imaging (fMRI): Within Participant Changes in Brain Signals as a Function of Stimulus Intensity
After each stimulus delivery, participants are prompted to indicate outcome ratings, i.e. the intensity of their stimulus experience. Ratings are recorded on a semi-circular scale (0-180 degrees), with categorical labels indicated on the scale (e.g. "no sensation" to "strongest sensation of any kind"). The investigators will analyze stimulus brain signal as a function of high vs. med vs. low stimulus intensity. We plan to construct contrasts of stimulus brain maps based on stimulus intensity of high vs. med vs. low.
Measured: Measured continuously during stimulus delivery, 1 hour of functional magnetic resonance imaging scanning. Each scan is conducted across 3 sessions.
Functional Magnetic Resonance Imaging (fMRI): Within Participant Changes in Brain Signals as a Function of High vs Low Cue
Investigator will model the brain event of each stimulus delivery event. From this, investigator will construct contrasts between stimulus brain maps as a function of high vs. low cue. Within each task of somatic pain, vicarious pain, and cognitive effort, we plan to both 1) average brain signals and 3) also isolate each event for further analyses.
Measured: Measured continuously during stimulus delivery, 1 hour of functional magnetic resonance imaging scanning. Each scan is conducted across 3 sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start23 Nov 2020
- Primary completion8 Jul 2022
- Study completion19 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PlaceboStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within-participant design with behavioral manipulations
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trustees of Dartmouth College
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Tor Wager, Trustees of Dartmouth College
- Investigators
- Tor D Wager, PhD, Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425563
- Sponsor's protocol ID
- STUDY00031937
- Other IDs
- 5R01MH076136
- Status last verified
- Nov 2023
- First submitted
- 15 Jun 2022
- Last updated
- 30 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators are strongly committed to contributing to open and reproducible science. De-identified data will be shared via public online platforms such as the Open Science Framework (OSF), OpenFMRI, OpenNeuro, NeuroVault, and/or the National Institute of Mental Health Data Archive (NDA). All scripts developed to analyze data for this project will be made publicly available on Github (https://github.com/canlab/CanlabCore) at the time of publication of primary manuscripts.
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Expectations on Negative Affect, Perceived Cognitive Effort, and Pain
- ClinicalTrials.gov ID
- NCT05425563
- Acronym / sponsor ID
- STUDY00031937
- Conditions
- Placebo, Expectations
- Keywords
- Social Placebo, Somatic Pain, Vicarious Pain, Cognitive Effort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Trustees of Dartmouth CollegeUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 19 Jan 2023 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Posted 30 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators administer a functional neuroimaging task to investigate the effect of cue expectancy on participants' self-reported ratings across a variety of affective and cognitive domains. The experiment incorporates three tasks in which participants experience and rate 1) somatic pain, 2) vicarious pain, and 3) cognitive effort. In the somatic pain task, participants receive a brief thermal stimulus administered to a site on their arm; in the vicarious pain task, participants watch a short video clip of a patient with back/shoulder pain; in the cognitive effort task, participants perform a cognitively demanding "mental rotation" task that requires them to indicate whether two 3D objects are the same or different when rotated along the y-axis. Each trial follows a sequence that begins with a fixation, followed by a social influence cue, then an expectation rating, followed by a condition-specific stimulus, and then, an actual rating of the outcome experience.
There are four events of interest: 1) cue perception, 2) expectation rating, 3) stimulus experience, and 4) outcome rating.
First, participants are presented with a cue that depicts how other participants responded to the upcoming stimulus ("cue perception"). Although the participant is told these are real ratings, they are in fact, fabricated data points that vary in intensity (low, high). Then, based on the provided cues, participants are prompted to report their expectation of the upcoming stimulus intensity ("expectation rating") After providing an expectation rating, participants are presented with a condition-specific stimulus (somatic pain, vicarious pain, or cognitive effort) that also varies in three levels of low, medium, high stimulus intensity ("stimulus experience"). Once the stimulus presentation has concluded, participants are prompted to provide an actual rating of their experience ("outcome rating"). For the somatic pain condition, participants rate their expectations and actual experience of how painful the stimulus was; for the vicarious pain condition, they rate their expectations and actual perception of how much pain the patient was in; and for the cognitive condition, the participant provides expectation and actual ratings of task difficulty.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within-participant design with behavioral manipulations
| Arm | Type | Receives |
|---|---|---|
| Cue-established expectations | Experimental | Behavioral: Pain Expectancy Cues, Behavioral: Vicarious Pain Expectancy Cues, Behavioral: Cognitive Effort Expectancy CuesPrior to experiencing the stimuli from three tasks (somatic pain/cognitive effort/vicarious pain), the participant is presented with an expectancy cue. The cue depicts 10 data points on a semi-circular scale (0-180 degrees) with categorical labels ranging from "no effort" to "strongest effort of any kind." Subsequently, participants report expectation ratings and outcome ratings. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Capable of performing experimental tasks (e.g., are able to read, can tolerate the maximum level of thermal pain stimuli).
- Fluent or native speakers of English
Key exclusion criteria (6 listed)
- Contraindications to magnetic resonance scanning (e.g., metal in body, claustrophobia, pregnancy)
- Substance abuse within the last six months
- Current or recent history of pathological pain
- Current or recent history of neurological disorders
- Currently or recent history of chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Expectancy CuesParticipants are presented with a social cue that represents how previous participants responded to the upcoming somatic pain stimulus. In actuality, the cue is a social placebo, constructed by the experimenters and varying in intensity. | Behavioural | Cue-established expectations |
| Vicarious Pain Expectancy CuesParticipants are presented with a social cue that represents how previous participants responded to the upcoming vicarious pain stimulus. In actuality, the cue is a social placebo, constructed by the experimenters and varying in intensity. | Behavioural | Cue-established expectations |
| Cognitive Effort Expectancy CuesParticipants are presented with a social cue that represents how previous participants responded to the upcoming cognitive effort stimulus. In actuality, the cue is a social placebo, constructed by the experimenters and varying in intensity. | Behavioural | Cue-established expectations |
Primary outcome
Behavioral: Within Participant Subjective Outcome Ratings of Acute Thermal Pain Following High Compared to Low Cues
Time frame: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, and contrasted to a single outcome measure: perceived pain as a function of high low cue exposure.
The outcome measure is the "subjective outcome rating" for perceived pain. In each session, participants undergo pain tasks with multiple thermal stimuli. After each stimulus, participants rate their perceived pain on a semi-circular scale (0-180°). Higher angles indicate greater perceived pain. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average rating after high cue and after low cue. The final outcome is the difference between these averages, forming a contrast score that reflects the average difference in perceived pain as a function of high and low cue exposure. * Scale: 0-180° * Min value: 0 * Max value: 180 * Higher scores indicate heightened pain perception.
Behavioral: Within Participant Subjective Outcome Ratings of Vicarious Pain Following High Compared to Low Cues
Time frame: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, and contrasted to a single outcome measure: perceived vicarious pain as a function of high low cue exposure.
The outcome measure is the "subjective outcome rating" for perceived vicarious pain. In each session, participants undergo vicarious pain tasks, watching multiple videos of patients in pain. After each stimulus, participants rate their perceived vicarious pain on a semi-circular scale (0-180°). Higher angles indicate that participants perceived greater pain for the patient in video. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average outcome rating after high cue and after low cue. The final outcome is the difference between these averages, forming a contrast score that reflects the average difference in perceived vicarious pain as a function of high and low cue exposure. * Scale: 0-180° * Min value: 0 * Max value: 180 * Higher scores indicate heightened perception of vicarious pain.
Behavioral: Within Participant Subjective Ratings of Cognitive Effort Following High Compared to Low Cues
Time frame: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, and contrasted to a single outcome measure: perceived cognitive effort as a function of high low cue exposure.
The outcome measure is the "subjective outcome rating" for cognitive effort. In each session, participants undergo cognitive effort task where images of mentally rotated figures are presented. After each stimulus, participants rate their perceived cognitive effort on a semi-circular scale (0-180°). Higher angles indicate greater perceived of cognitive effort. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average outcome rating after high cue and after low cue. The final outcome is the difference between these averages, forming a contrast score that reflects the average difference in perceived cognitive effort as a function of high and low cue exposure. * Scale: 0-180° * Min value: 0 * Max value: 180 * Higher scores indicate heightened perception of cognitive effort..
Behavioral: Within Participant Subjective Outcome Ratings of Acute Thermal Pain Following High Cues
Time frame: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of high cue exposure.
This outcome measure is the least metabolized data of "subjective outcome rating" for perceived pain. In each session, participants undergo pain tasks with multiple thermal stimuli. After each stimulus, participants rate their perceived pain on a semi-circular scale (0-180°). Higher angles indicate greater perceived pain. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average rating after high cue and after low cue. Reported here is the average subjective outcome rating, post-high cue. * Scale: 0-180° * Min value: 0 * Max value: 180 * Higher scores indicate heightened pain perception.
Behavioral: Within Participant Subjective Outcome Ratings of Acute Thermal Pain Following Low Cues
Time frame: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of low cue exposure.
This outcome measure is the least metabolized data of "subjective outcome rating" for perceived pain. In each session, participants undergo pain tasks with multiple thermal stimuli. After each stimulus, participants rate their perceived pain on a semi-circular scale (0-180°). Higher angles indicate greater perceived pain. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average rating after high cue and after low cue. Reported here is the average subjective outcome rating post-low cue. * Scale: 0-180° * Min value: 0 * Max value: 180 * Higher scores indicate heightened pain perception.
Behavioral: Within Participant Subjective Outcome Ratings of Vicarious Pain Following High Cues
Time frame: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of high cue exposure.
The outcome measure is the least metabolized data of "subjective outcome rating" for perceived vicarious pain. In each session, participants undergo vicarious pain tasks, watching multiple videos of patients in pain. After each stimulus, participants rate their perceived vicarious pain on a semi-circular scale (0-180°). Higher angles indicate that participants perceived greater pain for the patient in video. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average outcome rating after high cue and after low cue. Reported here is the average subjective outcome rating post high cue. * Scale: 0-180° * Min value: 0 * Max value: 180 * Higher scores indicate heightened perception of vicarious pain.
Behavioral: Within Participant Subjective Outcome Ratings of Vicarious Pain Following Low Cues
Time frame: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of low cue exposure.
The outcome measure is the least metabolized data of "subjective outcome rating" for perceived vicarious pain. In each session, participants undergo vicarious pain tasks, watching multiple videos of patients in pain. After each stimulus, participants rate their perceived vicarious pain on a semi-circular scale (0-180°). Higher angles indicate that participants perceived greater pain for the patient in video. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average outcome rating after high cue and after low cue. Reported here is the average subjective outcome rating post low cue. * Scale: 0-180° * Min value: 0 * Max value: 180 * Higher scores indicate heightened perception of vicarious pain.
Behavioral: Within Participant Subjective Ratings of Cognitive Effort Following High Cues
Time frame: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of high cue exposure.
The outcome measure is the least metabolized data of "subjective outcome rating" for cognitive effort. In each session, participants undergo cognitive effort task where images of mentally rotated figures are presented. After each stimulus, participants rate their perceived cognitive effort on a semi-circular scale (0-180°). Higher angles indicate greater perceived of cognitive effort. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average outcome rating after high cue and after low cue. Reported here is the average subjective outcome rating post high cue. * Scale: 0-180° * Min value: 0 * Max value: 180 * Higher scores indicate heightened perception of cognitive effort.
Behavioral: Within Participant Subjective Ratings of Cognitive Effort Following Low Cues
Time frame: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of low cue exposure.
The outcome measure is the least metabolized data of "subjective outcome rating" for cognitive effort. In each session, participants undergo cognitive effort task where images of mentally rotated figures are presented. After each stimulus, participants rate their perceived cognitive effort on a semi-circular scale (0-180°). Higher angles indicate greater perceived of cognitive effort. The "Outcome Measure Calculation": Ratings are grouped by cue type: High or Low. Data points in each group are averaged across sessions, yielding two measures: average outcome rating after high cue and after low cue. Reported here is the average subjective outcome rating post low cue. * Scale: 0-180° * Min value: 0 * Max value: 180 * Higher scores indicate heightened perception of cognitive effort.
13 secondary outcomes
Behavioral: Within Participant Expectation Ratings of Acute Thermal Pain Following High Compared to Low Cues
Time frame: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, and contrasted to a single outcome measure: expectations of pain as a function of high low cue exposure.
Behavioral: Within Participant Expectation Ratings of Vicarious Pain Following High Compared to Low Cues
Time frame: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, and contrasted to a single outcome measure: expectations of vicarious pain as a function of high low cue exposure.
Behavioral: Within Participant Expectation Ratings of Cognitive Effort Following High Compared to Low Cues
Time frame: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, and contrasted to a single outcome measure: expectations of cognitive effort as a function of high low cue exposure.
Behavioral: Within Participant Expectations Ratings of Acute Thermal Pain Following High Cues
Time frame: Within trials, outcome ratings are collected pre-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, and contrasted to a single outcome measure: expectations of pain as a function of high cue exposure.
Behavioral: Within Participant Expectations Ratings of Acute Thermal Pain Following Low Cues
Time frame: Within trials, outcome ratings are collected pre-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, and contrasted to a single outcome measure: expectations of pain as a function of low cue exposure.
Behavioral: Within Participant Expectation Ratings of Vicarious Pain Following High Cues
Time frame: Within trials, outcome ratings are collected pre-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting perceived vicarious pain as a function of high cue exposure.
Behavioral: Within Participant Expectation Ratings of Vicarious Pain Following Low Cues
Time frame: Within trials, outcome ratings are collected pre-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting perceived vicarious pain as a function of low cue exposure.
Behavioral: Within Participant Expectation Ratings of Cognitive Effort Following High Cues
Time frame: Within trials, outcome ratings are collected pre-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of high cue exposure.
Behavioral: Within Participant Expectation Ratings of Cognitive Effort Following Low Cues
Time frame: Within trials, outcome ratings are collected pre-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, reflecting: perceived pain as a function of low cue exposure.
Physiological: Within Participant Changes in Skin Conductance Response Measured With a Physiological Data Acquisition Device
Time frame: Measured continuously during each task, concurrent with stimulus delivery. Each task is distributed across 3 sessions. Within each task, we plan to average skin conductance rate across sessions.
Physiological: Within Participant Changes in Skin Conductance Rate Measured With a Physiological Data Acquisition Device
Time frame: Measured continuously during each task, concurrent with stimulus delivery. Each task is distributed across 3 sessions. Within each task, we plan to average skin conductance rate across sessions.
Functional Magnetic Resonance Imaging (fMRI): Within Participant Changes in Brain Signals as a Function of Stimulus Intensity
Time frame: Measured continuously during stimulus delivery, 1 hour of functional magnetic resonance imaging scanning. Each scan is conducted across 3 sessions.
Functional Magnetic Resonance Imaging (fMRI): Within Participant Changes in Brain Signals as a Function of High vs Low Cue
Time frame: Measured continuously during stimulus delivery, 1 hour of functional magnetic resonance imaging scanning. Each scan is conducted across 3 sessions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The investigators are strongly committed to contributing to open and reproducible science. De-identified data will be shared via public online platforms such as the Open Science Framework (OSF), OpenFMRI, OpenNeuro, NeuroVault, and/or the National Institute of Mental Health Data Archive (NDA). All scripts developed to analyze data for this project will be made publicly available on Github (https://github.com/canlab/CanlabCore) at the time of publication of primary manuscripts.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tor D Wager, PhD principal investigator
Dartmouth College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Expectancy Cues, Vicarious Pain Expectancy Cues and Cognitive Effort Expectancy Cues in people with Placebo and Expectations, run by Trustees of Dartmouth College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral: Within Participant Subjective Outcome Ratings of Acute Thermal Pain Following High Compared to Low Cues (time frame: Within trials, outcome ratings are collected post-stimulus (4s window); Trials are collected across 3 sessions. Ratings are then averaged, and contrasted to a single outcome measure: perceived pain as a function of high low cue exposure.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.