State-dependent Interoception, Value-based Decision-making, and Introspection

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Mental Health (NIMH)
Study ID
NCT05666726
Status
Recruiting
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Conditions

  • Craving
  • Emotions
  • Frustration
  • Pain
  • Stress

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Pain — OTHER
    Thermal pain
  • Stress — OTHER
    Stress state induction
  • Craving — BEHAVIORAL
    Snack craving induction
  • Frustration — BEHAVIORAL
    Real effort task
  • Negative valence emotion — BEHAVIORAL
    Passive video watching with emotional valence

Study Details

Background: Negative emotional states can affect a person s behavior as they make decisions. For example, hunger may make people more impatient; they may then make riskier choices. Other negative emotional states that can change behavior include stress, pain, and sadness. By learning more about how emotions affect thinking and behavior in healthy people, researchers hope to better understand how to identify and treat people with mental disorders. Objective: To learn how negative emotions affect the brain and decision-making behavior. Eligibility: Healthy people aged 18 to 55 years. Design: Participants will have 3 clinic visits in 3 weeks. Participants will fill out questionnaires. They will be asked about their personal history, their personality, and state of mind. For 2 visits, participants will be assigned to different groups. Each group will experience 1 type of emotional stressor: Some participants will watch a video. Some will have to do arithmetic problems. Some will have heat applied to an arm or leg. Some will experience cold by immersing their hand in ice water. For a snack craving test, some will be tempted by food after a 4-hour fast. During these tests, participants will have sensors attached to their bodies. They will be videotaped. Saliva samples will be collected. After the stressors, participants will do tasks on a computer. They will need to make choices. Some participants will perform these decision-making tasks while lying in a brain scanner for functional magnetic resonance imaging. The brain scan involves lying on a table that slides into a cylinder that takes images of the brain. ...

Key Dates

Start date
Jul 25, 2023
Status verified
Jan 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
900 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 1
    within-subjects experimental study, where each subject will receive a neutral state and a negative state induction intervention in a cross-over design (counterbalanced order across participants).
  • Experimental: 2
    within-subjects experimental study, where each subject will receive a neutral state and a negative state induction intervention in a cross-over design (counterbalanced order across participants).
  • Experimental: 3
    within-subjects experimental study, where each subject will receive a neutral state and a negative state induction intervention in a cross-over design (counterbalanced order across participants).
  • Experimental: 4
    within-subjects experimental study, where each subject will receive a neutral state and a negative state induction intervention in a cross-over design (counterbalanced order across participants).
  • Experimental: 5
    within-subjects experimental study, where each subject will receive a neutral state and a negative state induction intervention in a cross-over design (counterbalanced order across participants).

Primary Outcome Measure

Value-based decision-making metrics [ Time Frame: Right after intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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