Context Interventions: Social Modeling and Initial Treatment Experience
NCT ID: NCT04646460
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2025-12-01
2026-12-01
Brief Summary
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Detailed Description
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Humans are highly social creatures, and others' behavior and experiences can have profound effects on symptoms, physiology, and behavior. Social modeling-watching a similar other experience treatment benefits-may also strongly enhance placebo effects and their durability over time, particularly when combined with other context interventions. Social influences can affect core motivational circuitry (e.g., nAC and amygdala), shape learning trajectories, and appears to have distinct mechanisms from other (e.g., conditioning) manipulations. Their impact on brain mechanisms of placebo has not been studied. Likewise, initial perceived treatment success or failure can powerfully shape learning trajectories and placebo analgesia. Initial failure experiences with a treatment type (e.g., pill) may explain some of the treatment failures in studies that (a) attempt to wash out placebo responses with ineffective pills before starting verum drug, or (b) re-randomize non-responders to different pills, as in the STAR\*D antidepressant study. But the effects of initial success/failure experiences on the brain mechanisms of placebo effects have not been studied.
Design:
In an initial observation phase, participants will watch a video of another participant ("demonstrator") undergoing the baseline assessment and placebo test procedure. Next, participants will undergo a conditioning phase. The intervention is a 2 x 2 factorial between-groups manipulation (N = 30 per group) of social modeling (Observed treatment success vs. failure) and participants' initial success experience (Experienced success vs. failure). Thus, the demonstrator will either show strong signs of pain relief during placebo (Observed-Success condition) or no signs of relief (Observed-Failed treatment). During the conditioning phase, all participants will experience high-intensity heat before placebo treatment and then either low-intensity heat after application of a placebo cream, as in the investigator's and others' past work, creating experience of pain relief (Experienced-Success condition) or they will not experience relief (i.e., temperatures will not be lowered; Experienced-Failed treatment). In a subsequent fMRI test phase, participants experience painful heat and aversive IAPS images (as a transfer/specificity test) during fMRI, on skin sites treated with Control and Placebo creams, in a Control -\> Placebo -\> Control block design as in past research. Finally, a 3-month follow-up fMRI test phase, without additional observation or conditioning, will assess durability of brain and behavioral placebo effects.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
BASIC_SCIENCE
TRIPLE
Study Groups
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Observed Success - Experienced Success
This participant group (N=30) will witness a successful placebo during the "observation phase" (i.e. the demonstrator will display reduced pain expressions after receiving the cream) and experience a successful placebo during the "experience phase" (i.e. the experimenter will reduce the intensity of the pain stimuli after applying the cream).
Observed Success
The demonstrator in video gets a placebo treatment, "Levoderm" analgesic cream, which will be shown to be effective at relieving pain.
Experienced Success
The participant will receive reduced stimulus intensities after the placebo cream treatment to reinforce the effectiveness of the cream.
Observed Failure - Experienced Failure
This participant group (N=30) will witness a failed placebo during the "observation phase" (i.e. the demonstrator will not display reduced pain expressions after receiving the cream) and experience a failed placebo during the "experience phase" (i.e. the experimenter will not reduce the intensity of the pain stimuli after applying the cream).
Observed Failure
The demonstrator in the video gets the same placebo treatment, but shows little to no effectiveness from the placebo for relieving pain.
Experienced Failure
The participant will not receive reduced stimulus intensities after the placebo treatment, so the cream is not reinforced as effective.
Observed Success - Experienced Failure
This participant group (N=30) will witness a successful placebo during the "observation phase" (i.e. the demonstrator will not display reduced pain expressions after receiving the cream) and experience a failed placebo during the "experience phase" (i.e. the experimenter will not reduce the intensity of the pain stimuli after applying the cream).
Observed Success
The demonstrator in video gets a placebo treatment, "Levoderm" analgesic cream, which will be shown to be effective at relieving pain.
Experienced Failure
The participant will not receive reduced stimulus intensities after the placebo treatment, so the cream is not reinforced as effective.
Observed Failure - Experienced Success
This participant group (N=30) will witness a successful placebo during the "observation phase" (i.e. the demonstrator will display reduced pain expressions after receiving the cream) and experience a successful placebo during the "experience phase" (i.e. the experimenter will reduce the intensity of the pain stimuli after applying the cream).
Observed Failure
The demonstrator in the video gets the same placebo treatment, but shows little to no effectiveness from the placebo for relieving pain.
Experienced Success
The participant will receive reduced stimulus intensities after the placebo cream treatment to reinforce the effectiveness of the cream.
Interventions
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Observed Success
The demonstrator in video gets a placebo treatment, "Levoderm" analgesic cream, which will be shown to be effective at relieving pain.
Observed Failure
The demonstrator in the video gets the same placebo treatment, but shows little to no effectiveness from the placebo for relieving pain.
Experienced Success
The participant will receive reduced stimulus intensities after the placebo cream treatment to reinforce the effectiveness of the cream.
Experienced Failure
The participant will not receive reduced stimulus intensities after the placebo treatment, so the cream is not reinforced as effective.
Eligibility Criteria
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Inclusion Criteria
* No reported substance abuse within the last six months
* Capable of performing experimental tasks (e.g., are able to read, able to cooperate with fMRI examination)
* Fluent or native speakers of English
* No current or recent history of pathological pain or reported neurological disorders
* Abstained from alcohol and substance use for 48 hours
* Provided informed consent
* Passed fMRI screening test
Exclusion Criteria
* Current or past history of primary psychiatric disorder
* Current or past history of psychoactive substance abuse or dependence
* Dementias
* Movement disorders except familial tremor
* CNS infection
* CNS vasculitis, inflammatory disease or autoimmune disease
* CNS demyelinating disease (e.g. multiple sclerosis)
* Space occupying lesions (mass lesions, tumors)
* Congenital CNS abnormality (e.g. cerebral palsy)
* Seizure disorder
* History of closed head trauma with loss of consciousness
* History of cerebrovascular disease (stroke, TIAs)
* Abnormal MRI (except changes accounted for by technical factors or UBOs)
* Neuroendocrine disorders (e.g., Cushings disease)
* Uncorrected hypothyroidism or hyperthyroidism
* Current or past history of cancer
* Recent history (within two years) of myocardial infarction, severe cardiovascular disease, or currently active cardiovascular disease (e.g. angina, cardiomyopathy)
* Uncontrolled hypertension or hypotension
* Chronic pain syndromes
* Chronic fatigue syndromes
* Subjects unable to tolerate the scanning procedures (e.g., claustrophobia)
* Prior treatment within the last month with any of the following: antidepressants, mood stabilizers, glucocorticoids, opiates
* Prior treatment with any of the following: antipsychotics, isoniazid, centrally active antihypertensive drugs (e.g. clonidine, reserpine)
* Metal in body or prior history working with metal fragments (e.g., as a machinist)
* Pregnancy
* Any other contraindications for MRI examination (e.g., metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body)
* Claustrophobia
18 Years
55 Years
ALL
Yes
Sponsors
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Trustees of Dartmouth College
OTHER
Responsible Party
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Tor Wager
Diana L. Taylor Distinguished Professor
Principal Investigators
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Tor D Wager, PhD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth College
Locations
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Dartmouth College
Hanover, New Hampshire, United States
Countries
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Central Contacts
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Facility Contacts
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Bethany Hunt, BA
Role: primary
Other Identifiers
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230137
Identifier Type: -
Identifier Source: org_study_id