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

NCT ID: NCT05425563

Last Updated: 2023-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-23
• Study Completion Date: 2023-01-19

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Cue-established expectations

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.

Group Type: EXPERIMENTAL

Pain Expectancy Cues

Intervention Type: 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.

Vicarious Pain Expectancy Cues

Intervention Type: 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.

Cognitive Effort Expectancy Cues

Intervention Type: 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.

Interventions

Pain Expectancy Cues

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.

Intervention Type: BEHAVIORAL

Vicarious Pain Expectancy Cues

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.

Intervention Type: BEHAVIORAL

Cognitive Effort Expectancy Cues

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Trustees of Dartmouth College

OTHER

Sponsor Role: lead

Responsible Party

Tor Wager

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tor D Wager, PhD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth College

Locations

Dartmouth College

Hanover, New Hampshire, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5R01MH076136

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00031937

Identifier Type: -

Identifier Source: org_study_id