HealthyNOFNCT04664400

N-of-few Study of Pain Perception

A study testing Symbolic conditioning, Conditioning and Instructions in people with Healthy, run by Trustees of Dartmouth College at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A behavioral study that will examine how pain perception is affected by different types of conditioning and by context, with a few participants and multiple sessions ("N-of-few" design). Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Symbolic conditioning, Conditioning and Instructions
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 22 Jan 2021to 24 May 2021
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

Healthy participants

Who cannot join

Cannot tolerate heat pain applied to the forearm/leg, based on a calibration task at the beginning of the experiment

Trial locations and contacts

1 site in 1 country.

United States1 site

Dartmouth College
Hanover, New Hampshire, 03755

Other trials in United States

About this study

Official title: Common and Distinct Mechanisms of Expectancy Effects Across Outcomes

A behavioral study that will examine how pain perception is affected by different types of conditioning and by context, with a few participants and multiple sessions ("N-of-few" design).

Conditions: Healthy
Being tested: Symbolic conditioning, Conditioning, Instructions, Counterfactual

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Symbolic conditioningBehavioural
Participants will learn associations between cues and thermal stimuli with varying temperatures (low vs. high) through symbolic conditioning (no actual heat stimuli, only pictures of thermometers)
ConditioningBehavioural
Participants will learn associations between cues and thermal stimuli with varying temperatures (low vs. high) from experience (with actual heat stimuli).
InstructionsBehavioural
Participants will learn associations between cues and thermal stimuli with varying temperatures (low vs. high) from verbal instructions.
CounterfactualBehavioural
Thermal stimuli will be either the better outcome or the worse outcome out of two possible outcomes.

Study groups in NCT04664400
Study group	Role	What they receive
N-of-few Study of Pain	Experimental	Not described Receives: Behavioral: Symbolic conditioning; Behavioral: Conditioning; Behavioral: Instructions; Behavioral: Counterfactual

What is being measured

The primary outcome is the main question the study is designed to answer.

Within Participant Subjective Ratings of Acute Thermal Pain Following High Compared to Low Cues (Learned Via Symbolic Learning)
Each session of the experiment includes pain tasks, in which multiple thermal stimuli are delivered. Following each thermal stimulus, participants are asked to rate how painful it was, on a semi-circular computerized scale. Ratings are based on the angle (0-180), with higher angle representing higher pain ratings. In the symbolic learning procedure, cues are conditioned to different temperatures based on pictures of thermometers (instead of actual thermal stimuli as in the conditioning procedure). For the cues that were learned via symbolic learning, the investigators will compare the average rating of pain for stimuli that are preceded by high cues minus the average rating of pain for stimuli that are preceded by low cues (each averaged across sessions), within participant.
Measured: Measured repeatedly during pain tasks, in each of the 10 sessions of the experiment (up to 3 sessions per week, depending on the participants' availability), immediately after thermal stimuli. Averaged across sessions and compared across conditions.
Within Participant Subjective Ratings of Acute Thermal Pain Following High Compared to Low Cues (Learned Via Conditioning)
Each session of the experiment includes pain tasks, in which multiple thermal stimuli are delivered. Following each thermal stimulus, participants are asked to rate how painful it was, on a semi-circular computerized scale. Ratings are based on the angle (0-180), with higher angle representing higher pain ratings. In the conditioning procedure, cues are conditioned to different temperatures by delivering thermal stimuli with different temperatures after cues are presented (higher temperature following high cues and lower temperature following low cues). For the cues that were learned via conditioning, the investigators will compare the average rating of pain for stimuli that are preceded by high cues minus the average rating of pain for stimuli that are preceded by low cues (each averaged across sessions), within participant.
Measured: Measured repeatedly during pain tasks, in each of the 10 sessions of the experiment (up to 3 sessions per week, depending on the participants' availability), immediately after thermal stimuli. Averaged across sessions and compared across conditions.
Within Participant Subjective Ratings of Acute Thermal Pain Following High Compared to Low Cues (Learned Via Instructions Only)
Each session of the experiment includes pain tasks, in which multiple thermal stimuli are delivered. Following each thermal stimulus, participants are asked to rate how painful it was, on a semi-circular computerized scale. Ratings are based on the angle (0-180), with higher angle representing higher pain ratings. In the instructions only condition, cues are learned via verbal suggestion. For the cues that were learned via instructions only, the investigators will compare the average rating of pain for stimuli that are preceded by high cues minus the average rating of pain for stimuli that are preceded by low cues (each averaged across sessions), within participant.
Measured: Measured repeatedly during pain tasks, in each of the 10 sessions of the experiment (up to 3 sessions per week, depending on the participants' availability), immediately after thermal stimuli. Averaged across sessions and compared across conditions.
Within Participant Subjective Ratings of Acute Thermal Pain, When it is the Worse vs. the Better Alternative
In the counterfactual task, participants are presented with two alternatives (either two pain levels, or one pain level and either losing or gaining a certain amount of money). In these pairs of alternatives, the medium level pain is sometimes the better option (i.e., when the alternative is losing money or a more intense pain stimulus) and sometimes the worse option (i.e., when the other alternative is gaining money or a less intense pain stimulus). One of the two options is chosen by the computer (participants have no control on this choice). The investigators will compare the pain ratings (scale 0-180) within participant for the same level pain stimulus (medium intensity) when it is the worse vs. the better option.
Measured: Measured repeatedly during pain tasks, in each of the last 4 sessions of the experiment, immediately after thermal stimuli. Averaged across sessions and compared across conditions.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jan 202124 May 2021

First posted11 Dec 2020
Study start22 Jan 2021
Primary completion24 May 2021
Study completion24 May 2021

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 HealthyStudies 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: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04664400
Sponsor's protocol ID: 230134
Other IDs: 5R01MH076136
Acronym: NOF
Status last verified: Apr 2023
First submitted: 16 Nov 2020
Last updated: 18 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All de-identified data will be publicly shared via public online platforms such as the Open Science Framework (OSF) and Github, and the NIMH Data Archive (NDA), according to the terms and conditions outlined on their website (https://ndar.nih.gov/contribute\_data\_sharing\_regimen.html). Identifying information will not be released, including the facial videos, of which only non-identifiable features will be extracted and shared.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Common and Distinct Mechanisms of Expectancy Effects Across Outcomes
ClinicalTrials.gov ID: NCT04664400
Acronym / sponsor ID: NOF / 230134
Conditions: Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Trustees of Dartmouth CollegeUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 22 Jan 2021 (actual)
Primary completion: 24 May 2021 (actual)
Study completion: 24 May 2021 (actual)
First posted: 11 Dec 2020 (actual)
Results: Posted 18 Nov 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A behavioral study that will examine how pain perception is affected by different types of conditioning and by context, with a few participants and multiple sessions ("N-of-few" design).

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
N-of-few Study of Pain	Experimental	Behavioral: Symbolic conditioning, Behavioral: Conditioning, Behavioral: Instructions, Behavioral: Counterfactual

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy participants

Key exclusion criteria (1 listed)

Cannot tolerate heat pain applied to the forearm/leg, based on a calibration task at the beginning of the experiment

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
Symbolic conditioningParticipants will learn associations between cues and thermal stimuli with varying temperatures (low vs. high) through symbolic conditioning (no actual heat stimuli, only pictures of thermometers)	Behavioural	N-of-few Study of Pain
ConditioningParticipants will learn associations between cues and thermal stimuli with varying temperatures (low vs. high) from experience (with actual heat stimuli).	Behavioural	N-of-few Study of Pain
InstructionsParticipants will learn associations between cues and thermal stimuli with varying temperatures (low vs. high) from verbal instructions.	Behavioural	N-of-few Study of Pain
CounterfactualThermal stimuli will be either the better outcome or the worse outcome out of two possible outcomes.	Behavioural	N-of-few Study of Pain

Primary outcome

Within Participant Subjective Ratings of Acute Thermal Pain Following High Compared to Low Cues (Learned Via Symbolic Learning)
Time frame: Measured repeatedly during pain tasks, in each of the 10 sessions of the experiment (up to 3 sessions per week, depending on the participants' availability), immediately after thermal stimuli. Averaged across sessions and compared across conditions.
Each session of the experiment includes pain tasks, in which multiple thermal stimuli are delivered. Following each thermal stimulus, participants are asked to rate how painful it was, on a semi-circular computerized scale. Ratings are based on the angle (0-180), with higher angle representing higher pain ratings. In the symbolic learning procedure, cues are conditioned to different temperatures based on pictures of thermometers (instead of actual thermal stimuli as in the conditioning procedure). For the cues that were learned via symbolic learning, the investigators will compare the average rating of pain for stimuli that are preceded by high cues minus the average rating of pain for stimuli that are preceded by low cues (each averaged across sessions), within participant.
Within Participant Subjective Ratings of Acute Thermal Pain Following High Compared to Low Cues (Learned Via Conditioning)
Time frame: Measured repeatedly during pain tasks, in each of the 10 sessions of the experiment (up to 3 sessions per week, depending on the participants' availability), immediately after thermal stimuli. Averaged across sessions and compared across conditions.
Each session of the experiment includes pain tasks, in which multiple thermal stimuli are delivered. Following each thermal stimulus, participants are asked to rate how painful it was, on a semi-circular computerized scale. Ratings are based on the angle (0-180), with higher angle representing higher pain ratings. In the conditioning procedure, cues are conditioned to different temperatures by delivering thermal stimuli with different temperatures after cues are presented (higher temperature following high cues and lower temperature following low cues). For the cues that were learned via conditioning, the investigators will compare the average rating of pain for stimuli that are preceded by high cues minus the average rating of pain for stimuli that are preceded by low cues (each averaged across sessions), within participant.
Within Participant Subjective Ratings of Acute Thermal Pain Following High Compared to Low Cues (Learned Via Instructions Only)
Time frame: Measured repeatedly during pain tasks, in each of the 10 sessions of the experiment (up to 3 sessions per week, depending on the participants' availability), immediately after thermal stimuli. Averaged across sessions and compared across conditions.
Each session of the experiment includes pain tasks, in which multiple thermal stimuli are delivered. Following each thermal stimulus, participants are asked to rate how painful it was, on a semi-circular computerized scale. Ratings are based on the angle (0-180), with higher angle representing higher pain ratings. In the instructions only condition, cues are learned via verbal suggestion. For the cues that were learned via instructions only, the investigators will compare the average rating of pain for stimuli that are preceded by high cues minus the average rating of pain for stimuli that are preceded by low cues (each averaged across sessions), within participant.
Within Participant Subjective Ratings of Acute Thermal Pain, When it is the Worse vs. the Better Alternative
Time frame: Measured repeatedly during pain tasks, in each of the last 4 sessions of the experiment, immediately after thermal stimuli. Averaged across sessions and compared across conditions.
In the counterfactual task, participants are presented with two alternatives (either two pain levels, or one pain level and either losing or gaining a certain amount of money). In these pairs of alternatives, the medium level pain is sometimes the better option (i.e., when the alternative is losing money or a more intense pain stimulus) and sometimes the worse option (i.e., when the other alternative is gaining money or a less intense pain stimulus). One of the two options is chosen by the computer (participants have no control on this choice). The investigators will compare the pain ratings (scale 0-180) within participant for the same level pain stimulus (medium intensity) when it is the worse vs. the better option.

Results and safety

Results posted to the registry on 18 Nov 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
N-of-few Study of Pain	10	8

Primary outcome: Within Participant Subjective Ratings of Acute Thermal Pain Following High Compared to Low Cues (Learned Via Symbolic Learning)

Time frame: Measured repeatedly during pain tasks, in each of the 10 sessions of the experiment (up to 3 sessions per week, depending on the participants' availability), immediately after thermal stimuli. Averaged across sessions and compared across conditions.. Mean (Standard Deviation). Unit: score on a scale

Measure	N-of-few Study of Pain n = 8
Value	7.32 (10.41)

N-of-few Study of Pain: p = 0.043, t-test, 1 sided

Primary outcome: Within Participant Subjective Ratings of Acute Thermal Pain Following High Compared to Low Cues (Learned Via Conditioning)

Measure	N-of-few Study of Pain n = 8
Value	13.21 (17.72)

N-of-few Study of Pain: p = 0.036, t-test, 1 sided

Primary outcome: Within Participant Subjective Ratings of Acute Thermal Pain Following High Compared to Low Cues (Learned Via Instructions Only)

Measure	N-of-few Study of Pain n = 8
Value	13.76 (13.51)

N-of-few Study of Pain: p = 0.012, t-test, 1 sided

Primary outcome: Within Participant Subjective Ratings of Acute Thermal Pain, When it is the Worse vs. the Better Alternative

Time frame: Measured repeatedly during pain tasks, in each of the last 4 sessions of the experiment, immediately after thermal stimuli. Averaged across sessions and compared across conditions.. Mean (Standard Deviation). Unit: score on a scale

Measure	Main Arm n = 8
Value	-2.06 (5.57)

Main Arm: p = 0.835, t-test, 1 sided

Adverse events

Time frame: Adverse events were monitored for each participant until the end of their participation (i.e., their last session). Participants had 10 sessions of the experiment each, up to 3 sessions per week, depending on the participants' availability. Participants were instructed to report any unusual events happening shortly after the experiment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
N-of-few Study of Pain	0 of 8 (0%)	0 of 8 (0%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. All de-identified data will be publicly shared via public online platforms such as the Open Science Framework (OSF) and Github, and the NIMH Data Archive (NDA), according to the terms and conditions outlined on their website (https://ndar.nih.gov/contribute_data_sharing_regimen.html). Identifying information will not be released, including the facial videos, of which only non-identifiable features will be extracted and shared.

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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 Symbolic conditioning, Conditioning and Instructions in people with Healthy, 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 1 inclusion and 1 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 18 Apr 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 18 Nov 2022). 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?

Within Participant Subjective Ratings of Acute Thermal Pain Following High Compared to Low Cues (Learned Via Symbolic Learning) (time frame: Measured repeatedly during pain tasks, in each of the 10 sessions of the experiment (up to 3 sessions per week, depending on the participants' availability), immediately after thermal stimuli. Averaged across sessions and compared across conditions.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04664400.

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 18 Apr 2023.