The Effect of a Mind-body Exercise Program on Aspects of Attention in Individuals With Anxiety
Primary Purpose
Anxiety Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental mind-body intervention
Sponsored by
About this trial
This is an interventional other trial for Anxiety Disorder
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of anxiety must be able to understand procedures Exclusion Criteria: Clinical diagnosis of Alzheimer's Disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental mind-body intervention
Control group
Arm Description
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.
This group will be submitted to the same evaluation. However, they will wiat for 15 minutes with no intervention.
Outcomes
Primary Outcome Measures
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
Anxiety symptoms
A 14-item Hamilton anxiety scale will be applied, each item is scored from 0 (absent symptoms) to 4 (disabling symptoms)
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)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05818488
First Posted
March 14, 2023
Last Updated
September 19, 2023
Sponsor
Universidade Federal do Rio de Janeiro
1. Study Identification
Unique Protocol Identification Number
NCT05818488
Brief Title
The Effect of a Mind-body Exercise Program on Aspects of Attention in Individuals With Anxiety
Official Title
The Effect of a Mind-body Exercise Program on Aspects of Attention in Individuals With Anxiety: Protocol for a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental mind-body intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This group will be submitted to the same evaluation. However, they will wiat for 15 minutes with no intervention.
Intervention Type
Other
Intervention Name(s)
Experimental mind-body intervention
Intervention Description
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)
Primary Outcome Measure Information:
Title
interoceptive capacity.
Description
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
Time Frame
15 minutes after the intervention
Title
Anxiety symptoms
Description
A 14-item Hamilton anxiety scale will be applied, each item is scored from 0 (absent symptoms) to 4 (disabling symptoms)
Time Frame
15 minutes after the intervention
Title
Concentrated attention test
Description
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)
Time Frame
15 minutes after the intervention
Title
Digit Span test
Description
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.
Time Frame
15 minutes after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical diagnosis of anxiety
must be able to understand procedures
Exclusion Criteria:
Clinical diagnosis of Alzheimer's Disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Helena s Moraes, Dra
Phone
5521974430407
Email
helenasmoraes@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Érica Simone R Moraes
Phone
5521980873233
Email
ericamoraes.psicologia@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of a Mind-body Exercise Program on Aspects of Attention in Individuals With Anxiety
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