120 Participants Needed

Social Modeling Interventions for Enhancing Placebo Effect

TD
Overseen ByTor D Wager, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of 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.

Do I need to stop taking my current medications for the trial?

The trial requires that you have not taken antidepressants, mood stabilizers, glucocorticoids, or opiates in the last month. If you are currently on these medications, you may need to stop taking them before participating.

What data supports the effectiveness of the treatment Social Modeling Interventions for Enhancing Placebo Effect?

Research shows that the placebo effect, which is the improvement of symptoms due to the belief in treatment rather than the treatment itself, can be powerful in conditions like pain, depression, and neurological disorders. This suggests that enhancing the placebo effect through social modeling interventions could potentially improve outcomes by leveraging patient expectations and perceptions.12345

Is the Social Modeling Intervention for Enhancing Placebo Effect safe for humans?

Research on psychological interventions to influence placebo effects suggests they are generally safe, as they focus on changing expectations rather than using active medications. However, the quality of evidence is low, and more detailed studies are needed to confirm safety across different conditions.26789

How does the treatment in the Social Modeling Interventions for Enhancing Placebo Effect trial differ from other treatments?

This treatment is unique because it focuses on enhancing the placebo effect through social modeling, which involves using interpersonal and contextual factors to improve patient outcomes. Unlike traditional treatments that rely on direct pharmacological or mechanical interventions, this approach leverages the power of expectations and social interactions to achieve therapeutic benefits.310111213

Research Team

TD

Tor D Wager, PhD

Principal Investigator

Dartmouth College

Eligibility Criteria

This trial is for English-speaking individuals without psychiatric/neurological disorders, substance abuse history, or pathological pain. They must be able to perform tasks and undergo fMRI scans, not have metal implants, and abstain from alcohol/substances before the study.

Inclusion Criteria

I can read and cooperate with an fMRI exam.
No reported substance abuse within the last six months
I am a fluent or native English speaker.
See 5 more

Exclusion Criteria

I have metal in my body or have worked with metal fragments.
You were born with a brain condition like cerebral palsy.
I have a neuroendocrine disorder like Cushing's disease.
See 25 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Observation

Participants watch a video of another participant undergoing the baseline assessment and placebo test procedure

1 session
1 visit (in-person)

Conditioning

Participants undergo a conditioning phase experiencing high-intensity heat before placebo treatment and then either low-intensity heat after application of a placebo cream

1 session
1 visit (in-person)

fMRI Test

Participants experience painful heat and aversive IAPS images during fMRI, on skin sites treated with Control and Placebo creams

1 session
1 visit (in-person)

Follow-up

A 3-month follow-up fMRI test phase to assess durability of brain and behavioral placebo effects

3 months
1 visit (in-person)

Treatment Details

Interventions

  • Experienced Failure
  • Experienced Success
  • Observed Failure
  • Observed Success
Trial Overview The study examines how social modeling (observing treatment outcomes in others) and personal treatment experiences affect placebo effects on pain relief. Participants are divided into four groups to observe these effects using behavioral tests and fMRI scans over three months.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Observed Success - Experienced SuccessExperimental Treatment2 Interventions
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).
Group II: Observed Success - Experienced FailureExperimental Treatment2 Interventions
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).
Group III: Observed Failure - Experienced SuccessExperimental Treatment2 Interventions
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).
Group IV: Observed Failure - Experienced FailureExperimental Treatment2 Interventions
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).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Trustees of Dartmouth College

Lead Sponsor

Trials
32
Recruited
14,500+

Findings from Research

The placebo effect is linked to the brain's dopaminergic reward systems and is influenced by patients' expectations of treatment benefits, suggesting a biological basis for this phenomenon.
Evidence indicates that the placebo effect can be observed in various conditions, including Parkinson's disease, depression, and pain, highlighting its potential role in treatment strategies, even in long-term addiction recovery programs.
The placebo effect in neurological disorders.de la Fuente-Fernández, R., Schulzer, M., Stoessl, AJ.[2022]
The placebo effect can significantly relieve pain and improve affective disorders, indicating that inert medications can have real therapeutic benefits for patients.
Despite its potential, the placebo effect is often underutilized in clinical practice and inadequately assessed in clinical trials, highlighting the need for greater recognition and understanding of its mechanisms and impact.
A guide to the pharmacology of placebos.Gowdey, CW.[2022]
A review of 27 randomized controlled trials found that brief psychological interventions can influence how patients report side effects from active medications, suggesting that managing expectations may help reduce perceived side effects.
The most effective strategy identified was omitting side-effect information, while other techniques like distraction and altering branding perceptions showed inconsistent results, indicating a need for further research to refine these interventions.
Influencing Side-Effects to Medicinal Treatments: A Systematic Review of Brief Psychological Interventions.Webster, RK., Rubin, GJ.[2020]

References

The nature and power of the placebo effect. [2007]
Lessons to be learned from placebo arms in psychopharmacology trials. [2014]
Placebo interventions, placebo effects and clinical practice. [2021]
The placebo effect in neurological disorders. [2022]
A guide to the pharmacology of placebos. [2022]
Influencing Side-Effects to Medicinal Treatments: A Systematic Review of Brief Psychological Interventions. [2020]
["Placebo effect", from personal convictions to collective representations: A psychosocial reading of a pharmacodynamic phenomenon]. [2017]
Accounting for perception, placebo and unmasking effects in estimating treatment effects in randomised clinical trials. [2022]
Nonspecific medication side effects and the nocebo phenomenon. [2022]
Placebo effects: a new paradigm and relevance to psychiatry. [2023]
The placebo effect revisited: lessons learned to date. [2013]
12.United Statespubmed.ncbi.nlm.nih.gov
Conditioned placebo responses. [2019]
Optimizing Expectations via Mobile Apps: A New Approach for Examining and Enhancing Placebo Effects. [2023]
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