The Effect of a Mind-body Exercise Program on Aspects of Attention in Individuals With Anxiety

NCT05818488 | Unknown DMC

• 1 other identifier: IPUBBM
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

Mind-body exercises is a non-pharmacological intervention to mental health and can improve interoceptive capacity. Interoceptive is linked to the process of sensory information within the body playing an important role in behavior. Consequently, interoceptive can be modulated by mind-body training through sustained attention to breathing signals, certainty of movements, and also related to activation of brain processes. The present study aimed to evaluation the effect of mind-body in interoceptive capacity in individuals with anxiety. An anamnesis will be performed with demographic data, as well as questions about medications and physical and mental health history. After that, subjects will be randomized into an intervention (one session of mind-body exercises) where they will be asked to sit in a comfortable armchair and remain in a comfortable posture with their eyes closed. A meditation will be guided by an audio through headphones. The audio will last 15 minutes with an initial invitation to centering (full attention to the state of the body and the breath, bringing the attention to the present moment), followed by a body scan considering the seven dimensions of interoceptive capacity (noticing, not being distracted, not worrying, attentional regulation, emotional awareness, self-regulation, and trust) and the passive control group (waiting room), after the intervention the same cognitive tests will be reapplied. Then, the groups will be switched for a crossover analysis.

Conditions

Anxiety Disorder

Outcome Measures

Primary Outcomes (4)

• interoceptive capacity.

  Evaluated by the interoceptive awareness multidimensional assessment scale, the average of each of the seven dimensions is calculated, the higher the value, the higher the interoceptive capacity

  15 minutes after the intervention

• Anxiety symptoms

  A 14-item Hamilton anxiety scale will be applied, each item is scored from 0 (absent symptoms) to 4 (disabling symptoms)

  15 minutes after the intervention

• Concentrated attention test

  The D2-R Concentrated Attention Assessment Test evaluates the ability to concentrate attention, realized by the speed and accuracy with which the individual can discriminate symbols. The test is composed of the letters d or p, and 1 to 4 strokes. In total, get 13 different signs, of which three (d with 2 dashes) represent the target objects, the task is to cancel all the target objects of the test (d with 2 dashes)

  15 minutes after the intervention

• Digit Span test

  Assists in measuring the Distraction Resistance Index. The direct order is applied first applied first, followed by the reverse order, which is administered The direct order is applied first, followed by the reverse order, which is administered regardless if the examinee fails the direct order entirely. Each item is made up of two sets of digits constituting two trials, both of which are applied. attempts, both of which are applied. The maximum score on the subtest is 30 points, where the maximum raw score in direct order is 16 points while in reverse order it is 14 points.

  15 minutes after the intervention

Study Arms (2)

Experimental mind-body intervention

EXPERIMENTAL

subjects will be randomized into intervention (one session of mindbody exercise), where they will be asked to sit in a comfortable armchair and remain in a comfortable posture with eyes closed. Cognitive evaluation will be done before and after the intervention.

Other: Experimental mind-body intervention

Control group

NO INTERVENTION

This group will be submitted to the same evaluation. However, they will wiat for 15 minutes with no intervention.

Interventions

Experimental mind-body intervention OTHER

A meditation will be guided by an audio through headphones. The audio will last 15 minutes with an initial invitation to centering (full attention to the state of the body and the breath, bringing the attention to the present moment), followed by body scanning, followed by targeting the seven dimensions of interoceptive capacity (noticing, not being distracted, not worrying, attentional regulation, emotional awareness, self-regulation, and trust), and the passive control group (waiting room)

Experimental mind-body intervention

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of anxiety
• must be able to understand procedures

You may not qualify if:

• Clinical diagnosis of Alzheimer's Disease

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Helena s Moraes, Dra

CONTACT

5521974430407; helenasmoraes@gmail.com

Érica Simone R Moraes

CONTACT

5521980873233; ericamoraes.psicologia@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Student Mental Health

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: April 18, 2023
• Study Start: February 1, 2024
• Primary Completion: July 15, 2024
• Study Completion: December 20, 2024
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share