Clinical trial NCT05425563: Effects of Expectations on Negative Affect, Perceived Cognitive Effort, and Pain
Official title: Effects of Expectations on Negative Affect, Perceived Cognitive Effort, and Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Placebo
Expectations
Keywords: Social Placebo
Somatic Pain
Vicarious Pain
Cognitive Effort
Lead sponsor: Trustees of Dartmouth College
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Mental Health (NIMH)
First posted: 2022-06-21
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Within-participant design with behavioral manipulations
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Behavioral: Within Participant Subjective Outcome Ratings of Acute Thermal Pain Following High Compared to Low Cues
timeFrame: 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.
measure: Behavioral: Within Participant Subjective Outcome Ratings of Vicarious Pain Following High Compared to Low Cues
timeFrame: 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.
measure: Behavioral: Within Participant Subjective Ratings of Cognitive Effort Following High Compared to Low Cues
timeFrame: 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.
measure: Behavioral: Within Participant Subjective Outcome Ratings of Acute Thermal Pain Following High Cues
timeFrame: 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.
measure: Behavioral: Within Participant Subjective Outcome Ratings of Acute Thermal Pain Following Low Cues
timeFrame: 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.
measure: Behavioral: Within Participant Subjective Outcome Ratings of Vicarious Pain Following High Cues
timeFrame: 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.
measure: Behavioral: Within Participant Subjective Outcome Ratings of Vicarious Pain Following Low Cues
timeFrame: 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.
measure: Behavioral: Within Participant Subjective Ratings of Cognitive Effort Following High Cues
timeFrame: 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.
measure: Behavioral: Within Participant Subjective Ratings of Cognitive Effort Following Low Cues
timeFrame: 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:
measure: Behavioral: Within Participant Expectation Ratings of Acute Thermal Pain Following High Compared to Low Cues
timeFrame: 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.
measure: Behavioral: Within Participant Expectation Ratings of Vicarious Pain Following High Compared to Low Cues
timeFrame: 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.
measure: Behavioral: Within Participant Expectation Ratings of Cognitive Effort Following High Compared to Low Cues
timeFrame: 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.
measure: Behavioral: Within Participant Expectations Ratings of Acute Thermal Pain Following High Cues
timeFrame: 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.
measure: Behavioral: Within Participant Expectations Ratings of Acute Thermal Pain Following Low Cues
timeFrame: 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.
measure: Behavioral: Within Participant Expectation Ratings of Vicarious Pain Following High Cues
timeFrame: 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.
measure: Behavioral: Within Participant Expectation Ratings of Vicarious Pain Following Low Cues
timeFrame: 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.
measure: Behavioral: Within Participant Expectation Ratings of Cognitive Effort Following High Cues
timeFrame: 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.
measure: Behavioral: Within Participant Expectation Ratings of Cognitive Effort Following Low Cues
timeFrame: 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.
measure: Physiological: Within Participant Changes in Skin Conductance Response Measured With a Physiological Data Acquisition Device
timeFrame: 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.
measure: Physiological: Within Participant Changes in Skin Conductance Rate Measured With a Physiological Data Acquisition Device
timeFrame: 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.
measure: Functional Magnetic Resonance Imaging (fMRI): Within Participant Changes in Brain Signals as a Function of Stimulus Intensity
timeFrame: Measured continuously during stimulus delivery, 1 hour of functional magnetic resonance imaging scanning. Each scan is conducted across 3 sessions.
measure: Functional Magnetic Resonance Imaging (fMRI): Within Participant Changes in Brain Signals as a Function of High vs Low Cue
timeFrame: Measured continuously during stimulus delivery, 1 hour of functional magnetic resonance imaging scanning. Each scan is conducted across 3 sessions.
Other outcomes:
Locations:
city: Hanover
country: United States
facility: Dartmouth College
state: New Hampshire
Study officials:
affiliation: Dartmouth College
name: Tor D Wager, PhD
role: PRINCIPAL_INVESTIGATOR
References: