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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
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anxiety Disorder

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    March 14, 2023
    Last Updated
    September 19, 2023
    Sponsor
    Universidade Federal do Rio de Janeiro
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    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

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

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