Placebo EffectNCT07108101
Interactions Between Placebo Effects and Mindful Awareness State
A study testing tDCS stimulation (real), Mindful state induction and No minfulness induction in people with Placebo Effect and Mindfulness, run by Trustees of Dartmouth College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Placebo Effect, Mindfulness, Pain
- What is being tested?
- tDCS stimulation (real), Mindful state induction and No minfulness induction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2027to 30 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Dartmouth College
Hanover, New Hampshire, 03755
Tor Wager, Ph.D., 603-646-2196, tor.d.wager@dartmouth.edu
About this study
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).
Read the 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.
The analysis will involve assessing self-report measures, fMRI signatures, and autonomic reactivity to cues and task stimuli, similar to Experiment 1. The analysis will also explore the mediating role of interpersonal response (IPIX scores) and participants' initial responses to placebo.
The researchers plan to control for sex, age, and experimenter effects in all analyses and will test for potential biological sex differences, disaggregating the data if necessary. MRI data will not be acquired during tDCS to avoid artifacts, and the study is not designed to directly compare placebo tDCS with verum tDCS. However, it aims to investigate interpersonal and suggestion-related contributions to open-label treatment responses, providing a foundation for future studies on tDCS and its interactions with placebo effects.
- Being tested
- tDCS stimulation (sham), tDCS stimulation (real), Mindful state induction, No minfulness induction
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS stimulation (sham)Behavioural
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)Behavioural
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 inductionBehavioural
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 inductionBehavioural
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 group | Role | What they receive |
|---|---|---|
| mindfulness (session 1)+ real tdcs, sham tdcs (session 2) | Experimental | Assigned to the mindfulness group in session 1. Will experience real tdcs, followed by sham tdcs for session 2. Receives: Behavioral: tDCS stimulation (sham); Behavioral: tDCS stimulation (real); Behavioral: Mindful state induction |
| mindfulness (session 1) + sham tcds, real tdcs (session 2) | Experimental | Assigned to the mindfulness group in session 1. Will experience sham tdcs, followed by real tdcs for session 2. Receives: Behavioral: tDCS stimulation (sham); Behavioral: tDCS stimulation (real); Behavioral: Mindful state induction |
| no mindfulness (session 1) + real tdcs, sham tcds (session 2) | Experimental | Assigned to the no-mindfulness control group in session 1. Will experience real tdcs, followed by sham tdcs for session 2. Receives: Behavioral: tDCS stimulation (sham); Behavioral: tDCS stimulation (real); Behavioral: No minfulness induction |
| no mindfulness (session 1) + sham tdcs, real tdcs (session 2) | Experimental | Assigned to the no-mindfulness control group in session 1. Will experience sham tdcs, followed by real tdcs for session 2. Receives: Behavioral: tDCS stimulation (sham); Behavioral: tDCS stimulation (real); Behavioral: No minfulness induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Ratings
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.
Measured: 3-10 sec post-stimulus throughout testing sessions, with all sessions complete within 1 month
Subjective fear ratings
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"
Measured: 3-10 sec post-stimulus throughout testing sessions, with all sessions complete within 1 month
Cognitive effort ratings
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"
Measured: 3-10 sec post-stimulus throughout testing sessions, with all sessions complete within 1 month
Secondary outcomes (1)
Electrodermal autonomic responses to painful heat, fear-related images and cognitive effort.
Skin conductance (EDA) is recorded continuously throughout test sessions and per-stimulus amplitude of canonical stimulus-locked EDA responses is reported in microsiemens (uS). Higher values indicate a higher EDA response.
Measured: Peri-stimulus throughout testing sessions, with all sessions complete within 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Jun 2027 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placebo EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trustees of Dartmouth College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tor Wager, Trustees of Dartmouth College
- Investigators
- Tor Wager, Ph.D., Principal investigator, Dartmouth College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108101
- Sponsor's protocol ID
- 467254
- Status last verified
- Oct 2026
- First submitted
- 25 May 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactions Between Placebo Effects and Mindful Awareness State
- ClinicalTrials.gov ID
- NCT07108101
- Acronym / sponsor ID
- 467254
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Trustees of Dartmouth CollegeUniversity, hospital or other
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 6 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The analysis will involve assessing self-report measures, fMRI signatures, and autonomic reactivity to cues and task stimuli, similar to Experiment 1. The analysis will also explore the mediating role of interpersonal response (IPIX scores) and participants' initial responses to placebo.
The researchers plan to control for sex, age, and experimenter effects in all analyses and will test for potential biological sex differences, disaggregating the data if necessary. MRI data will not be acquired during tDCS to avoid artifacts, and the study is not designed to directly compare placebo tDCS with verum tDCS. However, it aims to investigate interpersonal and suggestion-related contributions to open-label treatment responses, providing a foundation for future studies on tDCS and its interactions with placebo effects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| mindfulness (session 1)+ real tdcs, sham tdcs (session 2) | Experimental | Behavioral: tDCS stimulation (sham), Behavioral: tDCS stimulation (real), Behavioral: Mindful state inductionAssigned to the mindfulness group in session 1. Will experience real tdcs, followed by sham tdcs for session 2. |
| mindfulness (session 1) + sham tcds, real tdcs (session 2) | Experimental | Behavioral: tDCS stimulation (sham), Behavioral: tDCS stimulation (real), Behavioral: Mindful state inductionAssigned to the mindfulness group in session 1. Will experience sham tdcs, followed by real tdcs for session 2. |
| no mindfulness (session 1) + real tdcs, sham tcds (session 2) | Experimental | Behavioral: tDCS stimulation (sham), Behavioral: tDCS stimulation (real), Behavioral: No minfulness inductionAssigned to the no-mindfulness control group in session 1. Will experience real tdcs, followed by sham tdcs for session 2. |
| no mindfulness (session 1) + sham tdcs, real tdcs (session 2) | Experimental | Behavioral: tDCS stimulation (sham), Behavioral: tDCS stimulation (real), Behavioral: No minfulness inductionAssigned to the no-mindfulness control group in session 1. Will experience sham tdcs, followed by real tdcs for session 2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS stimulation (sham)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). | Behavioural | mindfulness (session 1) + sham tcds, real tdcs (session 2), mindfulness (session 1)+ real tdcs, sham tdcs (session 2), no mindfulness (session 1) + real tdcs, sham tcds (session 2), no mindfulness (session 1) + sham tdcs, real tdcs (session 2) |
| tDCS stimulation (real)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). | Behavioural | mindfulness (session 1) + sham tcds, real tdcs (session 2), mindfulness (session 1)+ real tdcs, sham tdcs (session 2), no mindfulness (session 1) + real tdcs, sham tcds (session 2), no mindfulness (session 1) + sham tdcs, real tdcs (session 2) |
| Mindful state inductionExperimenters 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. | Behavioural | mindfulness (session 1) + sham tcds, real tdcs (session 2), mindfulness (session 1)+ real tdcs, sham tdcs (session 2) |
| No minfulness inductionParticipants 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. | Behavioural | no mindfulness (session 1) + real tdcs, sham tcds (session 2), no mindfulness (session 1) + sham tdcs, real tdcs (session 2) |
Primary outcome
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"
1 secondary outcome
Electrodermal autonomic responses to painful heat, fear-related images and cognitive effort.
Time frame: Peri-stimulus throughout testing sessions, with all sessions complete within 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tor Wager, Ph.D. principal investigator
Dartmouth College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS stimulation (real), Mindful state induction and No minfulness induction in people with Placebo Effect and Mindfulness, run by Trustees of Dartmouth College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tor Wager, Ph.D. (6036462196, tor.d.wager@dartmouth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Ratings (time frame: 3-10 sec post-stimulus throughout testing sessions, with all sessions complete within 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.