Context Interventions: Social Modeling and Initial Treatment Experience
1 other identifier
interventional
120
1 country
1
Brief Summary
In this experiment, the investigators study the brain pathways underlying several promising context interventions that enhance the strength of placebo effects. Specifically, the investigators examine the separate and joint effects of two of the most powerful context interventions: Social modeling-observing someone else being effectively treated-and prior treatment success or failure experiences. Participants will be randomized into 4 groups (Social modeling: observed success vs. observed failure and Conditioning: experienced success vs. experienced failure). The objectives are to investigate the placebo effect on pain relief and aversive image stimuli between and within-subjects. Each group will undergo a behavioral induction phase, fMRI placebo test phase, and an identical 3-month follow up fMRI placebo test phase. Follow-up assessment will provide some of the first evidence on predictors of the durability of placebo and context interventions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2020
CompletedFirst Posted
Study publicly available on registry
November 30, 2020
CompletedStudy Start
First participant enrolled
December 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
Study Completion
Last participant's last visit for all outcomes
December 1, 2028
January 16, 2026
January 1, 2026
1 year
November 13, 2020
January 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Intervention effects on pain ratings
Pain ratings will be given on a 0-100 scale. 0 being "no pain at all" and 100 being "most pain imaginable in the context of this study."
Immediately after pain stimuli
Intervention effects on aversive image ratings
Aversive ratings will be given on a 0-100 scale. 0 being "not unpleasant at all" and 100 being "very unpleasant."
Immediately after aversive image stimuli
Brain: signature responses to pain and aversive images
A priori regions of interest response from the brain (fMRI) patterns to the pain and aversive images.
Immediately after pain/image stimuli
Secondary Outcomes (5)
Skin conductance
Immediately after pain stimuli
Heart rate
Immediately after pain stimuli
Whole-brain maps of intervention effects
Immediately after pain stimuli
CliexaEase App ratings
Daily for: 2 weeks before scan, 2 weeks after last scan. Weekly for 1 year after last session.
Interpersonal Reactivity Index
Within two weeks before first fMRI scan
Study Arms (4)
Observed Success - Experienced Success
EXPERIMENTALThis 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 - Experienced Failure
EXPERIMENTALThis 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 Success - Experienced Failure
EXPERIMENTALThis 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 Failure - Experienced Success
EXPERIMENTALThis 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).
Interventions
The participant will not receive reduced stimulus intensities after the placebo treatment, so the cream is not reinforced as effective.
The demonstrator in video gets a placebo treatment, "Levoderm" analgesic cream, which will be shown to be effective at relieving pain.
The demonstrator in the video gets the same placebo treatment, but shows little to no effectiveness from the placebo for relieving pain.
The participant will receive reduced stimulus intensities after the placebo cream treatment to reinforce the effectiveness of the cream.
Eligibility Criteria
You may qualify if:
- No current psychiatric or major neurological diagnosis
- 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
You may not qualify if:
- Current presence of pain
- 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)
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dartmouth College
Hanover, New Hampshire, 03755, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tor D Wager, PhD
Dartmouth College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Diana L. Taylor Distinguished Professor
Study Record Dates
First Submitted
November 13, 2020
First Posted
November 30, 2020
Study Start (Estimated)
December 1, 2026
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2028
Last Updated
January 16, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- All data will be de-identified prior to sharing. Raw data will be submitted to NDA 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 NDA/OpenFMRI when the primary study manuscript is accepted.
- Access Criteria
- These data would generally be made available to any qualified investigator for neuroimaging studies only including: i. Research on any brain phenomenon; ii. Neuroimaging research on non-disease traits (intelligence, behavioral traits); iii. Methods development research. The requesting investigator must provide documentation of local IRB approval. These data would not be made available to: i. Any criminal justice organization, because data may not be used for any criminal justice applications; ii. Any commercial entity, because use of the data is limited to not-for-profit organizations and data may not be used for any commercial purposes.
The investigators are strongly committed to contributing to open and reproducible science. All MRI and behavioral data will be submitted to the NIMH Data Archive (NDA) according to the terms and conditions outlined on their website (https://ndar.nih.gov/contribute\_data\_sharing\_regimen.html ) and with OpenFMRI. The investigators will ensure that our IRB has approved our Data Sharing Plan. The investigators will use an informed consent document that permits subjects to allow sharing of de-identified (face removed) MRI and fMRI data with open-sharing repositories, including the NDA and OpenFMRI databases. The consent form will stipulate that: "Scientists can use my information, without personal identifiers, for any kind of genetic research."