Interactions Between Placebo Effects and Mindful Awareness State
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Pain Ratings
Study Overview
Brief Summary
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).
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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)
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: tDCS stimulation (sham) (Behavioral)
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.
Intervention: tDCS stimulation (real) (Behavioral)
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.
Intervention: Mindful state induction (Behavioral)
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.
Intervention: tDCS stimulation (sham) (Behavioral)
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.
Intervention: tDCS stimulation (real) (Behavioral)
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.
Intervention: tDCS stimulation (real) (Behavioral)
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.
Intervention: Mindful state induction (Behavioral)
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.
Intervention: tDCS stimulation (sham) (Behavioral)
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.
Intervention: tDCS stimulation (real) (Behavioral)
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.
Intervention: No minfulness induction (Behavioral)
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.
Intervention: tDCS stimulation (sham) (Behavioral)
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.
Intervention: No minfulness induction (Behavioral)
Outcomes
Primary Outcomes
Pain Ratings
Time Frame: 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
Time Frame: 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
Time Frame: 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"
Secondary Outcomes
- Electrodermal autonomic responses to painful heat, fear-related images and cognitive effort.(Peri-stimulus throughout testing sessions, with all sessions complete within 1 month)
Investigators
Tor Wager
Diana L. Taylor Distinguished Professor
Trustees of Dartmouth College
