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

The Effect of a Mind-body Exercise Program on Aspects of Attention in Individuals With Anxiety: Protocol for a Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety Disorder
• Intervention / Treatment: Other: Experimental mind-body intervention

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Helena s Moraes, Dra; Phone Number: 5521974430407; Email: helenasmoraes@gmail.com
• Study Contact Backup: Name: Érica Simone R Moraes; Phone Number: 5521980873233; Email: ericamoraes.psicologia@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Clinical diagnosis of Alzheimer's Disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental mind-body intervention; 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; 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)
No Intervention: Control group; This group will be submitted to the same evaluation. However, they will wiat for 15 minutes with no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio de Janeiro

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): July 15, 2024
• Study Completion (Estimated): December 20, 2024

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: April 5, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: IPUBBM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No