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NCT04646460

Context Interventions: Social Modeling and Initial Treatment Experience

Sponsor: Trustees of Dartmouth College

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-12-01

Completion Date

2028-12-01

Last Updated

2026-01-16

Healthy Volunteers

Yes

Conditions

Placebo Effect Pain

Interventions

BEHAVIORAL

Observed Success

The demonstrator in video gets a placebo treatment, "Levoderm" analgesic cream, which will be shown to be effective at relieving pain.

BEHAVIORAL

Observed Failure

The demonstrator in the video gets the same placebo treatment, but shows little to no effectiveness from the placebo for relieving pain.

BEHAVIORAL

Experienced Success

The participant will receive reduced stimulus intensities after the placebo cream treatment to reinforce the effectiveness of the cream.

BEHAVIORAL

Experienced Failure

The participant will not receive reduced stimulus intensities after the placebo treatment, so the cream is not reinforced as effective.

Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 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

Locations (1)

Dartmouth College

Hanover, New Hampshire, United States

Clinical Research Directory

Context Interventions: Social Modeling and Initial Treatment Experience

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (1)