- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06237530
Interoception and Body Scan
January 30, 2024 updated by: Rosa M. Baños Rivera, University of Valencia
Exploring Visceral Body Scan, Somatosensory Body Scan, and External Meditation
Body scan meditation has been assumed to be an interoceptive intervention, and the evidence for its effects on interoceptive processes is unclear.
Although this mindfulness based exercise typically involves focusing on some interoceptive signals such as breath, it also involves other bodily cues, such as somatosensory cues.
The present study aimed to (1) investigate the feasibility of three online delivered mindfulness practices that differ in the signals targeted: visceral body scan (VBS), somatosensory body scan (SBS), and external (non body) meditation (ECM), and (2) gain insight into the potentially different effects of these interventions on interoceptive and other psychological outcomes in order to inform future full scale randomized controlled trials (RCT).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Comunidad Valenciana
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Valencia, Comunidad Valenciana, Spain, 46010
- Faculty of Psychology and Speech Therapy, University of Valencia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Age over 18
- being Spanish or English speakers
- Ability to use a computer or smartphone
- Daily access to computer or smartphone with an Internet connection
Exclusion Criteria:
- Being diagnosed with a severe psychiatric disorder (e.g., substance abuse, eating disorder, psychotic disorder)
- Severe visual or auditory difficulties that cannot be corrected with glasses or auditory aids
- Having a medical condition that prevents participation in this study
- Changes in psychotropic medication during the study
- Having been exposed to any extremely traumatic event that is being re-experienced or interfering during the last month
- Body image-related difficulties as indicated by scores above 3 on the Body Image as Source of Shame questionnaire.
- Regular meditation practice in the current moment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Visceral Body Scan (VBS)
The VBS consisted of a mindfulness exercise designed to bring awareness to visceral sensations in the cardiac, respiratory, gastrointestinal, and urinary systems.
These physiological systems were chosen because most of the paradigms developed in the literature to assess interoception focus on them (Khalsa et al., and they are widely recognized in the literature as interoceptive senses (Nord & Garfinkel, 2022)
|
The VBS consisted of a mindfulness exercise designed to bring awareness to visceral sensations in the cardiac, respiratory, gastrointestinal, and urinary systems.
These physiological systems were chosen because most of the paradigms developed in the literature to assess interoception focus on them (Khalsa et al., and they are widely recognized in the literature as interoceptive senses (Nord & Garfinkel, 2022)
Other Names:
|
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Active Comparator: Somatosensory body scan (SBS)
The SBS consisted of a mindfulness exercise designed to bring awareness to tactile (e.g., itching) and musculoskeletal (e.g.
g., tension) sensations in different parts of the body, namely, the head and neck, back, arms, and legs.
Body scan exercises typically focus on these types of bodily cues (in addition to breathing) (Williams, 2010).
|
The SBS consisted of a mindfulness exercise designed to bring awareness to tactile (e.g., itching) and musculoskeletal (e.g.
g., tension) sensations in different parts of the body, namely, the head and neck, back, arms, and legs.
Body scan exercises typically focus on these types of bodily cues (in addition to breathing) (Williams, 2010).
Other Names:
|
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Sham Comparator: External control meditation (ECM)
The ECM consisted of a mindfulness exercise designed to bring awareness to external stimuli, including sounds and visual properties of the environment
|
The ECM consisted of a mindfulness exercise designed to bring awareness to external stimuli, including sounds and visual properties of the environment.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence assessed by completed intervention sessions
Time Frame: Through study completion, a total of 7 days
|
Percentage of completed daily sessions during the 7-day intervention
|
Through study completion, a total of 7 days
|
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Meditation-related adverse effects assessed by a self-report questionnaire
Time Frame: Immediately post-intervention
|
Meditation-Related Adverse Effect Scale - Mindfulness-Based Program.
It includes 11 dichotomic items (yes/no questions), so scores ranges from 0 to 11, with higher scores indicating more adverse effects
|
Immediately post-intervention
|
|
Acceptability assessed by a satisfaction questionnaire
Time Frame: Immediately post-intervention
|
Treatment Satisfaction Scale.
It includes 5 items rated on Likert-point scale ranging from 0 to 10.
Thus, total scores range from 0 to 50, with higher scores indicating greater acceptability of the intervention
|
Immediately post-intervention
|
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Self-reported quality of the mindfulness practice
Time Frame: Immediately post-intervention
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Practice Quality-Mindfulness.
It consists of 6 items rated on a visual analogue scale ranging from 0 to 100, with higher scores reflecting a higher level of practice quality.
|
Immediately post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adaptive interoceptive sensibility style assessed by a questionnaire
Time Frame: Immediately pre-intervention and immediately post-intervention
|
Multidimensional Assessment of Interoceptive Awareness-2.
It consists of 37 items rated on a 6-point Likert scale, with higher values indicating a more adaptive and healthier interoceptive sensibility style (healthier approach to internal bodily signals).
|
Immediately pre-intervention and immediately post-intervention
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Sensitivity and attention to interoceptive signals assessed by a questionnaire
Time Frame: Immediately pre-intervention and immediately post-intervention
|
Interoceptive Sensitivity and Attention Questionnaire.
It consists of 17 items rated on a 5-point Likert scale, ranging from 1 (totally disagree) to 5 (totally agree).
Higher scores reflect greater sensitivity to bodily sensations
|
Immediately pre-intervention and immediately post-intervention
|
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Perceived Body Boundaries in bodily self-awareness assessed by a VAS
Time Frame: Immediately pre-intervention and immediately post-intervention
|
Perceived Body Boundaries Scale.
It is visual analogue scale that depicts seven human bodies, ranging from almost imperceptible at the left pole (labeled "my body boundaries are almost imperceptible") to extremely salient at the right pole (labeled my body boundaries are extremely salient").
Scores can range from 0 to 15.5, with higher scores indicating greater salience in perceiving body boundaries.
|
Immediately pre-intervention and immediately post-intervention
|
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Spatial Frame of Reference in bodily self-awareness assessed by a VAS
Time Frame: Immediately pre-intervention and immediately post-intervention
|
Spatial Frame of Reference Continuum.
It is a visual analogue scale depicting five concentric circles surrounding the outline of a human figure, and individuals are asked to indicate how far they feel that their self extends beyond their physical body.
Scores range from 1 to 6, with higher scores reflecting a more allocentric (vs.
egocentric) frame of reference.
|
Immediately pre-intervention and immediately post-intervention
|
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Mindfulness trait assessed by a self-report questionnaire
Time Frame: Immediately pre-intervention and immediately post-intervention
|
Short form of the Five Facet Mindfulness Questionnaire.
It is a 15-item instrument that measures the tendency to be mindful in daily life.
Items are rated on a 5-point Likert scale, from 1 (never or very rarely true) to 5 (very often or always true).
It includes the following dimensions: observing, describing, acting with awareness, non judging internal experience, and non reactivity to internal experience.
Higher scores indicate higher levels of the corresponding mindfulness dimension.
|
Immediately pre-intervention and immediately post-intervention
|
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Alexithymia assessed by a self-report questionnaire
Time Frame: Immediately pre-intervention and immediately post-intervention
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The Perth Alexithymia Questionnaire Questionnaire-Short Form.
It includes 7 items rated on a 7-point Likert scale (1=strongly disagree; 7=strongly agree), with higher scores indicating higher levels of alexithymia
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Immediately pre-intervention and immediately post-intervention
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Negative emotion regulation assessed by a self-report questionnaire
Time Frame: Immediately pre-intervention and immediately post-intervention
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Short-form version of the Difficulties in Emotion Regulation Scale.
It is an 18 item questionnaire that measures the degree of difficulty in regulating emotions.
Items are rated on a 5 point Likert scale, ranging from 1 (almost never) to 5 almost always).
It includes the following dimensions: (1) lack of emotional awareness of one's own emotions; (2) self reported difficulty in completing tasks and concentrating in the presence of negative emotions; (3) limited access to regulatory strategies that the in dividual perceives as effective; (4) nonacceptance of negative emotional states; (5) self reported difficulty in controlling one's behavior in the presence of negative emotional states, and (6) lack of emotional clarity, i.e., limited knowledge and clarity about one's emotional states.
Higher scores indicate higher difficulties in regulating emotions.
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Immediately pre-intervention and immediately post-intervention
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Positive emotion regulation assessed by a self-report questionnaire
Time Frame: Immediately pre-intervention and immediately post-intervention
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Responses to Positive Affect Questionnaire.
It is a 16 item questionnaire that measures responses to positive moods, including dampening (i.e., thoughts that are likely to dampen positive emotional states), self focused positive rumination (i.e., rumination on aspects of the self and the pursuit of goals relevant to the self), and emotion focused positive rumination (i.e., rumination on positive mood).
Items are rated on a 4 point Likert scale, ranging from 1 almost never ) to 4 almost always ), with higher scores reflecting a greater use of such strategy.
|
Immediately pre-intervention and immediately post-intervention
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Depressive symptomatology assessed by a self-report questionnaire
Time Frame: Immediately pre-intervention and immediately post-intervention
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Patient Health Questionnaire-9.
It consists of 9 items, which are rated on a 4-point Likert scale, ranging from 0 (never) to 4 (almost every day).
Higher scores indicate greater severity of depressive symptoms.
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Immediately pre-intervention and immediately post-intervention
|
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Qualitative feedback assessed by several open-ended questions
Time Frame: Immediately pre-intervention and immediately post-intervention
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Ad-hoc open-ended questions: ended questions: (1) "Do you think that participating in this study has helped you learn something or become aware of something?
If so, what did you learn?"; (2) Do you think that doing the meditation practice has helped you improve anything?
If so, what benefits have you noticed noticed?"; (3) Does this practice make sense to you, and why? "; (4) Please describe the sensations, thoughts and/or feelings you have had while doing the meditation practice "; (5) What difficulties have you found when doing the meditation practice?";
(6) What did you like most about the meditation practice?
And what did you like the least?", and (7) What do you think is the objective or hypothesis of the study?".
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Immediately pre-intervention and immediately post-intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rosa M Baños, PhD, Univeristy of Valencia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 26, 2023
Primary Completion (Actual)
August 21, 2023
Study Completion (Actual)
August 21, 2023
Study Registration Dates
First Submitted
December 4, 2023
First Submitted That Met QC Criteria
January 30, 2024
First Posted (Estimated)
February 1, 2024
Study Record Updates
Last Update Posted (Estimated)
February 1, 2024
Last Update Submitted That Met QC Criteria
January 30, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 2569173
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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