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

Sponsor
Universidade Federal do Rio de Janeiro (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05818488
Collaborator
(none)
16
2
8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Experimental mind-body intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
The Effect of a Mind-body Exercise Program on Aspects of Attention in Individuals With Anxiety: Protocol for a Randomized Controlled Trial
Anticipated Study Start Date :
Apr 20, 2023
Anticipated Primary Completion Date :
Jul 20, 2023
Anticipated Study Completion Date :
Dec 20, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. interoceptive capacity. [15 minutes after the intervention]

    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

  2. Anxiety symptoms [15 minutes after the intervention]

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

  3. Concentrated attention test [15 minutes after the intervention]

    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)

  4. Digit Span test [15 minutes after the intervention]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • clinical diagnosis of anxiety

  • must be able to understand procedures

Exclusion Criteria:
  • Clinical diagnosis of Alzheimer's Disease

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Universidade Federal do Rio de Janeiro

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Erica Simone Rodrigues Moraes, Master Student Mental Health, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT05818488
Other Study ID Numbers:
  • IPUBBM
First Posted:
Apr 18, 2023
Last Update Posted:
Apr 18, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 18, 2023