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临床试验/NCT07108101
NCT07108101尚未招募不适用

Interactions Between Placebo Effects and Mindful Awareness State

Trustees of Dartmouth College2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
2
主要终点
Pain Ratings

研究概览

简要总结

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).

详细描述

This study aims to investigate the effects of interpersonally induced placebo effects and a mindful awareness induction on negative affect. The study will involve 120 participants recruited from the Dartmouth College community, aged between 18 and 55, with an equal distribution of 60 males and 60 females. Participants will be assigned to the role of "patient" and will undergo fMRI scanning and physiological recording while performing the Multimodal Negative Affect Task (MNAT).

The study design follows a 2 x 2 factorial design, 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. A follow-up transfer assessment (1 week follow-up, session 2) will be conducted to examine the effects of the mindful state on verum motor tDCS stimulation. The participants will be randomly assigned to either the Mindfulness group or the No-mindfulness group, with 60 participants in each group and two sessions for each participant.

In session 1, participants in the Mindfulness group will undergo a Mindful State Induction procedure aimed at promoting safety, relaxation, and receptivity. This induction procedure consists of two stages. In the first stage, participants will receive education about the brain's connection to and regulation of the body, emphasizing the endogenous brain regulatory capacities. The second stage involves a hypnotic induction of a relaxed state of receptivity using the Stanford Hypnotic Induction Profile (HIP) test of hypnotizability. This stage includes reclining the participant, suggesting that they are always in control, and making somatic suggestions to deepen the receptive state. A guided body scan, derived from mindfulness meditation, will further deepen the induced receptive state.

In contrast, 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.

During the transfer test, conducted in a second fMRI session one week later, we will assess transfer to verum, open-label motor-cortex tDCS in an off-on-off design (both groups), with no explicit mindful state induction. No MRI data will be acquired during tDCS to avoid MR artifacts. We will also assess spontaneous use of strategies, including self-regulation and spontaneous adoption of states of mindful acceptance, and test whether these differ across groups.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • No self-reported current or history of depression, bipolar disorder, or other psychiatric diagnosis
  • No self-reported current seizure disorder (i.e., seizure within past 10 years), or history of stroke or other major neurological diagnosis that can cause cognitive impairment
  • No self-reported current chronic pain, or acute pain within three months of the study period
  • No current migraine disorder (i.e., 15 headache days or more in 1 month)
  • No use of central nervous system-effective medication or other medication for neurological/psychiatric treatment
  • No self-reported substance abuse within the last six months
  • No contraindication to MRI or tDCS (e.g., pregnancy, claustrophobia, pacemakers, ear/cochlear implants, shrapnel injuries, clips, or other ferromagnetic/electrical objects/devices, diagnosed brain abnormality such as tumor, or skin lesions on the scalp.)
  • No contraindications for induced pain (e.g., no heart disease, high blood pressure, heart surgery, heart problems of any kind, severe asthma, respiratory problems of any kind, fibromyalgia, Raynaud's Syndrome or Disease, chronic pain, diabetes)
  • Participants must be capable of performing experimental tasks (e.g., are able to read), are fluent or native speakers of English
  • Participants must be able to tolerate the maximum level of thermal pain stimuli (for thermal stimuli)

排除标准

  • 未提供

结局指标

主要结局

Pain Ratings

时间窗: 3-10 sec post-stimulus throughout testing sessions, with all sessions complete within 1 month

Participants report subjective pain experience after each trial on a well-validated Generalized Linear Magnitude scale (GLMS) with anchors of "No pain" and "Most intense pain imaginable". Raw units are on a 0-180 scale.

Subjective fear ratings

时间窗: 3-10 sec post-stimulus throughout testing sessions, with all sessions complete within 1 month

Participants report subjective fear experience after each trial on a well-validated Generalized Linear Magnitude scale (GLMS) with anchors of "No fear" and "Most intense fear imaginable"

Cognitive effort ratings

时间窗: 3-10 sec post-stimulus throughout testing sessions, with all sessions complete within 1 month

Participants report cognitive effort experience after each trial on a well-validated Generalized Linear Magnitude scale (GLMS) with anchors of "No effort" and "Most effort imaginable"

次要结局

  • Electrodermal autonomic responses to painful heat, fear-related images and cognitive effort.(Peri-stimulus throughout testing sessions, with all sessions complete within 1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tor Wager

Diana L. Taylor Distinguished Professor

Trustees of Dartmouth College

研究点 (2)

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