Well-Being, PsychologicalNCT06351787
Project Soma: Cortical Activity of a Body Scan Meditation and Yoga Practice in Healthy Yogis
A study testing Resting and movement-based focused awareness meditations in people with Well-Being, Psychological, run by Ohio University at 1 site in United States.
Trial summary
In this 2-armed randomized cross-sectional experimental study of healthy participants with yoga experience, we will examine the relationship between 4 self-reported enhancing psychological factors, cortical activity captured with functional near-infrared spectroscopy (fNIRS), and pain sensitivity (mechanical pressure… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Well-Being, Psychological
- What is being tested?
- Resting and movement-based focused awareness meditations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2022to 28 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults currently engaged in yoga
Who cannot join
- History of any neurological disorder that could impair brain function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cortical Activity of a Body Scan Meditation and Yoga Practice in Healthy Adults: Correlates With Interoceptive Awareness, Healthy Emotionality, and Pain Perception
In this 2-armed randomized cross-sectional experimental study of healthy participants with yoga experience, we will examine the relationship between 4 self-reported enhancing psychological factors, cortical activity captured with functional near-infrared spectroscopy (fNIRS), and pain sensitivity (mechanical pressure pain tolerance) captured with algometry.
Specifically, we will examine the correlates of interoceptive awareness and mindful awareness with cortical activity (Aim 1a) and pain tolerance (Aim 1b); determine cortical activity responsiveness of two brief awareness-focused meditations - a resting-based body scan practice and yoga practice (Aim 2a); characterize cortical activity profiles with sequentially delivered body scan and yoga practices (Aim 2b); and elucidate the relationship between interoceptive awareness with healthy emotionality and psychological wellbeing (Aim 3).
Our central hypotheses are that (Aim 1a) higher interoceptive awareness and mindful awareness will moderately correlate with higher cortical activity for both awareness-focused meditation practices; (Aim 1b) individuals sub-grouped into the 'acceptance in action cluster' based on 2 self-report measures will exhibit higher pain tolerance; (Aim 2a) cortical activity will be higher in the yoga practice compared to the body scan practice; and (Aim 2b) higher cortical activity will be observed in the body scan->yoga intervention sequence compared to the yoga->body scan intervention sequence. Furthermore, (Aim 3) we predict that interoceptive awareness will moderately correlate with healthy emotionality and psychological well-being.
Read the detailed description
In Aim 1a, we will use self-report measures of interoception and awareness, using the Multidimensional Assessment of Interoceptive Awareness (MAIA) and the Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF), and fNIRS to capture cortical activity during brief exposures to resting (Body scan) and movement-based (yoga) practices. We predict that self-reported interoception and awareness will moderately, and directly correlate with prefrontal cortical activity during the Body Scan and Yoga practices. In other words, we expect that higher levels of self-reported interoception and awareness will be positively associated with higher levels of prefrontal cortical activity for both awareness-focused practices.
In Aim 1b, we will use (i) the self-report measures (MAIA and FFMQ-SF) to identify a 'regulatory awareness' cluster and 'acceptance in action' cluster, and (ii) the quantitative sensory test of pressure pain tolerance. We will test the hypothesis that individuals categorized into the 'acceptance in action' cluster will demonstrate higher pressure pain threshold and tolerance compared to the 'regulatory awareness' cluster.
In Aim 2, we will use cortical activity levels captured using fNIRS during two awareness-based practices - Body Scan and Yoga. We expect that cortical activity will be higher during Yoga compared to Body Scan (Aim 2a). We further expect that individuals who initially receive the resting-based meditation and then progress to receive the active-based meditation (Body Scan->Yoga) will at a group level demonstrate higher levels of cortical activity in comparison to individuals who receive Yoga->Body Scan (Aim 2b).
In Aim 3, we will use self-report measures of interoception (MAIA) and self-report measures of healthy emotionality (Emotional Styles Questionnaire, ESQ) and psychological well-being (Scales of Psychological Well-Being, PWB). We predict that interoception will be moderately correlated with healthy emotionality and psychological well-being.
Our contribution will be significant because elucidating cognitive and affective processes of awareness-based practices will help inform who may more favorably respond to different awareness-based practices aimed at cultivating well-being. Our proposed research is innovative because it seeks to advance a sensorimotor and psychological mechanistic understanding of meditation practices that will elucidate the 'active ingredients' responsible for its therapeutic effect.
- Conditions
- Well-Being, Psychological
- Being tested
- Resting and movement-based focused awareness meditations
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resting and movement-based focused awareness meditationsBehavioural
Resting and movement-based focused awareness meditations
| Study group | Role | What they receive |
|---|---|---|
| Body scan | Experimental | Participants will follow an audio-guided meditation in the sitting posture, which provides systematic verbal cues to draw their attention to different body parts to cultivate non-judgmental awareness. This will be performed in blocks of 2-minute increments, for up to 10 minutes, interspersed with 30-second periods of rest - where the participant will allow their mind to wander freely. Receives: Behavioral: Resting and movement-based focused awareness meditations |
| Yoga | Experimental | Participants will follow a video-guided yoga session in the standing posture, which provides verbal and visual cues to draw their attention to their body and breath during upright yoga postures. This practice occurs in 2-minute active intervals for up to 10 minutes, interspersed with 30-second rest to be consistent with the experimental block design. Receives: Behavioral: Resting and movement-based focused awareness meditations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical activity
Oxy-Hb and De-Oxy-Hb
Measured: Baseline (T0)
Interoceptive awareness
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Measured: Baseline (T0)
Mindful awareness
Five Facet Mindfulness Questionnaire - Short form (FFMQ-SF)
Measured: Baseline (T0)
Pressure pain threshold and tolerance
Computerized pressure pain algometry applied over the ventral thenar eminence, 3 series of ascending stimulus intensities, applied as a slowly increasing ramp of 50 kPa/s. Pain threshold is defined as the first perception or detection of pain, or a numeric rating of 2 on a scale of 0 to 10, where 0 = no sensation and 10 = worst imaginable pain. Pain tolerance is defined as the point of maximum tolerable pain, a numeric pain rating of 8 on a scale of 0 to 10.
Measured: Baseline (T0)
Secondary outcomes (2)
Healthy emotionality
Emotional Styles Questionnaire (ESQ)
Measured: Baseline (T0)
Well-being
Scales of Psychological Well-Being (SPWB)
Measured: Baseline (T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start31 Oct 2022
- Primary completion28 Jun 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-Being, PsychologicalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A 2-armed randomized cross-sectional experimental study with 20 healthy participants who hold yoga experience.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas Karayannis, Principal investigator, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351787
- Sponsor's protocol ID
- 22-X-97
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Activity of a Body Scan Meditation and Yoga Practice in Healthy Adults: Correlates With Interoceptive Awareness, Healthy Emotionality, and Pain Perception
- ClinicalTrials.gov ID
- NCT06351787
- Acronym / sponsor ID
- 22-X-97
- Conditions
- Well-Being, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 8 Apr 2024 (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 2-armed randomized cross-sectional experimental study of healthy participants with yoga experience, we will examine the relationship between 4 self-reported enhancing psychological factors, cortical activity captured with functional near-infrared spectroscopy (fNIRS), and pain sensitivity (mechanical pressure pain tolerance) captured with algometry.
Specifically, we will examine the correlates of interoceptive awareness and mindful awareness with cortical activity (Aim 1a) and pain tolerance (Aim 1b); determine cortical activity responsiveness of two brief awareness-focused meditations - a resting-based body scan practice and yoga practice (Aim 2a); characterize cortical activity profiles with sequentially delivered body scan and yoga practices (Aim 2b); and elucidate the relationship between interoceptive awareness with healthy emotionality and psychological wellbeing (Aim 3).
Our central hypotheses are that (Aim 1a) higher interoceptive awareness and mindful awareness will moderately correlate with higher cortical activity for both awareness-focused meditation practices; (Aim 1b) individuals sub-grouped into the 'acceptance in action cluster' based on 2 self-report measures will exhibit higher pain tolerance; (Aim 2a) cortical activity will be higher in the yoga practice compared to the body scan practice; and (Aim 2b) higher cortical activity will be observed in the body scan->yoga intervention sequence compared to the yoga->body scan intervention sequence. Furthermore, (Aim 3) we predict that interoceptive awareness will moderately correlate with healthy emotionality and psychological well-being.
Detailed description
In Aim 1a, we will use self-report measures of interoception and awareness, using the Multidimensional Assessment of Interoceptive Awareness (MAIA) and the Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF), and fNIRS to capture cortical activity during brief exposures to resting (Body scan) and movement-based (yoga) practices. We predict that self-reported interoception and awareness will moderately, and directly correlate with prefrontal cortical activity during the Body Scan and Yoga practices. In other words, we expect that higher levels of self-reported interoception and awareness will be positively associated with higher levels of prefrontal cortical activity for both awareness-focused practices.
In Aim 1b, we will use (i) the self-report measures (MAIA and FFMQ-SF) to identify a 'regulatory awareness' cluster and 'acceptance in action' cluster, and (ii) the quantitative sensory test of pressure pain tolerance. We will test the hypothesis that individuals categorized into the 'acceptance in action' cluster will demonstrate higher pressure pain threshold and tolerance compared to the 'regulatory awareness' cluster.
In Aim 2, we will use cortical activity levels captured using fNIRS during two awareness-based practices - Body Scan and Yoga. We expect that cortical activity will be higher during Yoga compared to Body Scan (Aim 2a). We further expect that individuals who initially receive the resting-based meditation and then progress to receive the active-based meditation (Body Scan->Yoga) will at a group level demonstrate higher levels of cortical activity in comparison to individuals who receive Yoga->Body Scan (Aim 2b).
In Aim 3, we will use self-report measures of interoception (MAIA) and self-report measures of healthy emotionality (Emotional Styles Questionnaire, ESQ) and psychological well-being (Scales of Psychological Well-Being, PWB). We predict that interoception will be moderately correlated with healthy emotionality and psychological well-being.
Our contribution will be significant because elucidating cognitive and affective processes of awareness-based practices will help inform who may more favorably respond to different awareness-based practices aimed at cultivating well-being. Our proposed research is innovative because it seeks to advance a sensorimotor and psychological mechanistic understanding of meditation practices that will elucidate the 'active ingredients' responsible for its therapeutic effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A 2-armed randomized cross-sectional experimental study with 20 healthy participants who hold yoga experience.
| Arm | Type | Receives |
|---|---|---|
| Body scan | Experimental | Behavioral: Resting and movement-based focused awareness meditationsParticipants will follow an audio-guided meditation in the sitting posture, which provides systematic verbal cues to draw their attention to different body parts to cultivate non-judgmental awareness. This will be performed in blocks of 2-minute increments, for up to 10 minutes, interspersed with 30-second periods of rest - where the participant will allow their mind to wander freely. |
| Yoga | Experimental | Behavioral: Resting and movement-based focused awareness meditationsParticipants will follow a video-guided yoga session in the standing posture, which provides verbal and visual cues to draw their attention to their body and breath during upright yoga postures. This practice occurs in 2-minute active intervals for up to 10 minutes, interspersed with 30-second rest to be consistent with the experimental block design. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults currently engaged in yoga
Key exclusion criteria (1 listed)
- History of any neurological disorder that could impair brain function
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 |
|---|---|---|
| Resting and movement-based focused awareness meditationsResting and movement-based focused awareness meditations | Behavioural | Body scan, Yoga |
Primary outcome
Cortical activity
Time frame: Baseline (T0)
Oxy-Hb and De-Oxy-Hb
Interoceptive awareness
Time frame: Baseline (T0)
Multidimensional Assessment of Interoceptive Awareness (MAIA)
Mindful awareness
Time frame: Baseline (T0)
Five Facet Mindfulness Questionnaire - Short form (FFMQ-SF)
Pressure pain threshold and tolerance
Time frame: Baseline (T0)
Computerized pressure pain algometry applied over the ventral thenar eminence, 3 series of ascending stimulus intensities, applied as a slowly increasing ramp of 50 kPa/s. Pain threshold is defined as the first perception or detection of pain, or a numeric rating of 2 on a scale of 0 to 10, where 0 = no sensation and 10 = worst imaginable pain. Pain tolerance is defined as the point of maximum tolerable pain, a numeric pain rating of 8 on a scale of 0 to 10.
2 secondary outcomes
Healthy emotionality
Time frame: Baseline (T0)
Well-being
Time frame: Baseline (T0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Nicholas Karayannis principal investigator
Ohio University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resting and movement-based focused awareness meditations in people with Well-Being, Psychological, run by Ohio University 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 8 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortical activity (time frame: Baseline (T0)). The study lists 4 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 8 Apr 2024.