Context Interventions: Social Modeling and Initial Treatment Experience
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorTrustees of Dartmouth College
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Current presence of pain
Current or past history of primary psychiatric disorder
Current or past history of psychoactive substance abuse or dependence
Dementias
Trial design
Design model
Factorial
Treatments tested in this trial
Observed Success
BehavioralThe demonstrator in video gets a placebo treatment, "Levoderm" analgesic cream, which will be shown to be effective at relieving pain.
Observed Failure
BehavioralThe demonstrator in the video gets the same placebo treatment, but shows little to no effectiveness from the placebo for relieving pain.
Experienced Success
BehavioralThe participant will receive reduced stimulus intensities after the placebo cream treatment to reinforce the effectiveness of the cream.
Experienced Failure
BehavioralThe participant will not receive reduced stimulus intensities after the placebo treatment, so the cream is not reinforced as effective.
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: Observed Success - Experienced SuccessExperimental treatment 2 interventions
Group B: Observed Failure - Experienced FailureExperimental treatment 2 interventions
Group C: Observed Success - Experienced FailureExperimental treatment 2 interventions
Group D: Observed Failure - Experienced SuccessExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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."
Time frame
Immediately after pain stimuli2
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."
Time frame
Immediately after aversive image stimuli3
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.
Time frame
Immediately after pain/image stimuliSecondary outcomes
1
Skin conductance
Skin conductance response (SCR) will be recorded during the task.
Time frame
Immediately after pain stimuli2
Heart rate
Heart rate will be recorded during the task.
Time frame
Immediately after pain stimuli3
Whole-brain maps of intervention effects
Exploratory brain analysis will include univariate voxel-wise maps comparing participant groups with a threshold of q \< 0.05, False Discovery Rate (FDR)-corrected.
Time frame
Immediately after pain stimuli4
CliexaEase App ratings
Participants click an "I feel" button to display a list of feelings (i.e., happiness, sadness, pain, fear, stress, etc.), and then can drag a feeling bubble to a bodily location (or to a location indicating "not felt in the body"), and then rate the intensity of the feeling on a visual analog scale. This assessment is open-ended to minimize demand characteristics.
Time frame
Daily for: 2 weeks before scan, 2 weeks after last scan. Weekly for 1 year after last session.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: