Interoception and Body Scan

Healthy Clinical Trial

Official title:

Exploring Visceral Body Scan, Somatosensory Body Scan, and External Meditation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06237530
• Other study ID #: 2569173
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 26, 2023
• Est. completion date: August 21, 2023

Study information

• Verified date: January 2024
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 21, 2023
• Est. primary completion date: August 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• 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)
• 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).
• 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.

Locations

Country	Name	City	State
Spain	Faculty of Psychology and Speech Therapy, University of Valencia	Valencia	Comunidad Valenciana

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence assessed by completed intervention sessions	Percentage of completed daily sessions during the 7-day intervention	Through study completion, a total of 7 days
Primary	Meditation-related adverse effects assessed by a self-report questionnaire	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
Primary	Acceptability assessed by a satisfaction questionnaire	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
Primary	Self-reported quality of the mindfulness practice	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	Adaptive interoceptive sensibility style assessed by a questionnaire	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
Secondary	Sensitivity and attention to interoceptive signals assessed by a questionnaire	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
Secondary	Perceived Body Boundaries in bodily self-awareness assessed by a VAS	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
Secondary	Spatial Frame of Reference in bodily self-awareness assessed by a VAS	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
Secondary	Mindfulness trait assessed by a self-report questionnaire	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
Secondary	Alexithymia assessed by a self-report questionnaire	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	Immediately pre-intervention and immediately post-intervention
Secondary	Negative emotion regulation assessed by a self-report questionnaire	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.	Immediately pre-intervention and immediately post-intervention
Secondary	Positive emotion regulation assessed by a self-report questionnaire	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
Secondary	Depressive symptomatology assessed by a self-report questionnaire	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.	Immediately pre-intervention and immediately post-intervention
Secondary	Qualitative feedback assessed by several open-ended questions	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?".	Immediately pre-intervention and immediately post-intervention