Effects of Mind-body Exercises in a Patient With Mood Disorders: a Case Study.
Primary Purpose
Mood Disorders, Mind-body Exercise
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
interoceptive mind-body exercise
Sponsored by
About this trial
This is an interventional other trial for Mood Disorders
Eligibility Criteria
Inclusion Criteria: Participants with anxiety or/and depression clinical diagnosis Participants who do not do formal meditation practices Exclusion Criteria: Participants with other diagnosis Patients with cognitive conditions
Sites / Locations
- Federal University of Rio de Janeiro
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
mind-body intervention
Arm Description
Outcomes
Primary Outcome Measures
Mnteroceptive capacity
assessed by interoceptive scale named Multidimensional Assessment of Interoceptive Awareness. In this scale, the average of each of the seven dimensions is calculated, the higher the value, the greater the interoceptive capacity.
Anxiety symptoms
To measure the level of anxiety symptoms the Hamilton Anxiety scale was performed. The Hamilton Anxiety Scale has 14 items, each item is scored from 0 (absent symptoms) to 4 (disabling symptoms(, The higher the scores, the greater the levels of anxiety.
Depression symptons
Hamilton Depression was used to measure the level of depression symptons. It has 21 items, where the scores for symptoms from 0 to 5. The higher the scores, the greater the levels of depression.
Secondary Outcome Measures
Full Information
NCT ID
NCT05667844
First Posted
November 29, 2022
Last Updated
December 27, 2022
Sponsor
Universidade Federal do Rio de Janeiro
1. Study Identification
Unique Protocol Identification Number
NCT05667844
Brief Title
Effects of Mind-body Exercises in a Patient With Mood Disorders: a Case Study.
Official Title
Effects of Mind-body Exercises in a Patient With Mood Disorders: a Case Study.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
May 10, 2022 (Actual)
Study Completion Date
August 15, 2022 (Actual)
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
The interoception capacity may be changed with mind-body intervention. This study case investigated the interoceptive capacity, measured by MAIA scale of a pacient with mood disorders and if it can be influenced through of a 7 weeks intervention of interoceptive exercises and the impaction in the patient´s daily life. The aim was analyse the effects of mind-body exercise program with interoceptive approach in the anxiety and depression symptoms, interoceptive capacity, as well your impact in paitient's daily activities. M.S is 47 years old, was forwarded from University Hospital Clementino Fraga Filho to extension project named as "corpo&mente" (body-mind), an anamnesis was performed including patient's life story, interoceptive scale, anxiety and depression scale from Hamilton and a risk stratification to realize physical activities (it was also performed post-intervention). The exercise program lasted 1h 15 min and it was performed once a week.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Disorders, Mind-body Exercise
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Study case
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mind-body intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
interoceptive mind-body exercise
Intervention Description
A interoceptive mind-body exercise program in a patient with Generalized Anxiety Disorder and Major Depressive Disorder based on a Multidimensional Assessment of Interoceptive Awareness. Each session of the body-mind intervention lasts 80 minutes and is supervised by physical education professionals. The intervention is divided in 4 parts, that are: Preparatory phase (reception) the subjects will be welcomed through subjective analyzes of the researcher; Initial phase (preliminares) Mindfulness, grounding, sensory stimulation and joint warm-up exercises are performed; main phase (exercises) stretching, mobility, posture and balance exercises are performed with full attention and listening after each exercise; Final phase (relaxation) breathing exercises, stretching exercises, body scanning and relaxation are performed.
Primary Outcome Measure Information:
Title
Mnteroceptive capacity
Description
assessed by interoceptive scale named Multidimensional Assessment of Interoceptive Awareness. In this scale, the average of each of the seven dimensions is calculated, the higher the value, the greater the interoceptive capacity.
Time Frame
Day 1
Title
Anxiety symptoms
Description
To measure the level of anxiety symptoms the Hamilton Anxiety scale was performed. The Hamilton Anxiety Scale has 14 items, each item is scored from 0 (absent symptoms) to 4 (disabling symptoms(, The higher the scores, the greater the levels of anxiety.
Time Frame
Day 1 and after 7 weeks
Title
Depression symptons
Description
Hamilton Depression was used to measure the level of depression symptons. It has 21 items, where the scores for symptoms from 0 to 5. The higher the scores, the greater the levels of depression.
Time Frame
Day 1 and after 7 weeks
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants with anxiety or/and depression clinical diagnosis
Participants who do not do formal meditation practices
Exclusion Criteria:
Participants with other diagnosis
Patients with cognitive conditions
Facility Information:
Facility Name
Federal University of Rio de Janeiro
City
Rio De Janeiro
ZIP/Postal Code
22290-140
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Mind-body Exercises in a Patient With Mood Disorders: a Case Study.
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