Interactions Between Placebo Effects and Mindful Awareness State

Part of paid clinical trials in Hanover, New Hampshire.

Sponsor
Trustees of Dartmouth College
Study ID
NCT07108101
Status
Not Yet Recruiting

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Conditions

  • Mindfulness
  • Pain
  • Placebo Effect
  • Transcranial Direct Current Stimulation (tDCS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • tDCS stimulation (sham) — BEHAVIORAL
    Participants will receive sham tDCS stimulation in a 20 minute long task. Targets will be fitted with the tDCS stimulation electrode cap and instructed that they will receive 20 minutes of tDCS stimulation for the task. Sham tDCS will target the motor cortex at 2mA for 15 sec at the beginning of the session, and then the stimulator will turn off. The participant will then sit for the remaining time of the session with the electrode cap on their heads but turned off and not delivering stimulation. All participants will receive sham tDCS stimulation (n=120).
  • tDCS stimulation (real) — BEHAVIORAL
    In their second session, participants will receive real tDCS stimulation in a 20 minute long task. Targets will be fitted with the tDCS stimulation electrode cap and instructed that they will receive 20 minutes of tDCS stimulation for the task. Real tDCS stimulation will target the motor cortex at 2mA for 20 minutes (full duration of task). All participants will receive real tDCS stimulation (n=120).
  • Mindful state induction — BEHAVIORAL
    Experimenters trained in high-competence and high-warmth will train Group 1 participants on mindful state induction (n=60). Participants will undergo two stages for this training: 1) pain education to increase beliefs in endogenous brain regulatory capacities; and 2) the Stanford Hypnotic Induction Profile (HIP) test of hypnotizability and hypnotic induction of a relaxed state receptive to suggestion. In Stage 1, participants will receive education that pain and affect are processes designed to protect the body from danger, which are transmitted rapidly and automatically to the brain. In Stage 2, participants are (a) seated in an upright, alert posture; and (b) receive suggestions that the ability to attend to and discriminate affective perceptions is achievable and that suppressing attention to the body and focusing on the task will allow them to perform optimally under pressure. Mindful state induction will only be explicitly instructed during session 1 for Group 1 participants.
  • No minfulness induction — BEHAVIORAL
    Participants in the No-mindfulness group will go through comparable stages but with different instructions. In the first stage, they will receive education about pain and affect as protective processes of the body. In the second stage, they will be seated in an upright, alert posture and receive suggestions to focus on the task and suppress attention to the body.

Study Details

In this experiment,the investigators study the effects of interpersonally induced placebo effects and a mindful awareness induction on negative affect. Specifically, it will be examining the effects of interpersonally induced placebo effects (sham tDCS vs. control) and a mindful awareness induction (mindful state vs. control), as well as their interaction. Each group will undergo fMRI scanning and physiological recording will performing the Multimodal Negative Affect Task (MNAT).

Key Dates

Start date
Jun 1, 2026
Status verified
Jul 2025
Primary completion
Jun 1, 2028
Completion
Nov 30, 2028

Study Design

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

Arms

  • Experimental: mindfulness (session 1)+ real tdcs, sham tdcs (session 2)
    Assigned to the mindfulness group in session 1. Will experience real tdcs, followed by sham tdcs for session 2.
  • Experimental: mindfulness (session 1) + sham tcds, real tdcs (session 2)
    Assigned to the mindfulness group in session 1. Will experience sham tdcs, followed by real tdcs for session 2.
  • Experimental: no mindfulness (session 1) + real tdcs, sham tcds (session 2)
    Assigned to the no-mindfulness control group in session 1. Will experience real tdcs, followed by sham tdcs for session 2.
  • Experimental: no mindfulness (session 1) + sham tdcs, real tdcs (session 2)
    Assigned to the no-mindfulness control group in session 1. Will experience sham tdcs, followed by real tdcs for session 2.

Primary Outcome Measure

Pain Ratings [ Time Frame: 3-10 sec post-stimulus throughout testing sessions, with all sessions complete within 1 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dartmouth CollegeHanoverNew Hampshire03755
Tor Wager, Ph.D.
603-646-2196

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