Effects of Expectations on Negative Affect, Perceived Cognitive Effort, and Pain

NCT05425563 | Completed Results

• 2 other identifiers: STUDY000319375R01MH076136
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Placebo; Expectations

Keywords

Social Placebo; Somatic Pain; Vicarious Pain; Cognitive Effort

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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..

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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

  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

  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

  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

  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.

Study Arms (1)

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.

Behavioral: Pain Expectancy Cues; Behavioral: Vicarious Pain Expectancy Cues; Behavioral: Cognitive Effort Expectancy Cues

Interventions

Pain Expectancy Cues BEHAVIORAL

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.

Cue-established expectations

Vicarious Pain Expectancy Cues BEHAVIORAL

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.

Cue-established expectations

Cognitive Effort Expectancy Cues BEHAVIORAL

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.

Cue-established expectations

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trustees of Dartmouth College: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Dartmouth College

Hanover, New Hampshire, 03755, United States

Location

MeSH Terms

Conditions

Nociceptive Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Tor Wager, professor
• Organization: Dartmouth College

tor@dartmouth.edu

603-646-2196

Study Officials

• Tor D Wager, PhD

  Dartmouth College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Within-participant design with behavioral manipulations

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: November 23, 2020
• Primary Completion: July 8, 2022
• Study Completion: January 19, 2023
• Last Updated: November 30, 2023
• Results First Posted: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: All data will be de-identified prior to sharing. Raw data will be submitted to the NDA in accordance with the terms and conditions outlined on their website (https://ndar.nih.gov/contribute\ data\ sharing\ regimen.html) and will be publicly released within one year from the end of data collection or 6 months from the acceptance date of the first primary study manuscript on the full dataset (excluding methods development papers), whichever is later. Analyzed data/maps of statistical results and models accompanying each paper will be submitted to public repositories (OSF, OpenFMRI, OpenNeuro, and/or NeuroVault) when the primary study manuscript is accepted. All data will be shared indefinitely.

Locations

US (1)