- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05667844
Effects of Mind-body Exercises in a Patient With Mood Disorders: a Case Study.
December 27, 2022 updated by: Karoline Almeida Pereira, Universidade Federal do Rio de Janeiro
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Rio De Janeiro, Brazil, 22290-140
- Federal University of Rio de Janeiro
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: mind-body intervention
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mnteroceptive capacity
Time Frame: Day 1
|
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.
|
Day 1
|
|
Anxiety symptoms
Time Frame: Day 1 and after 7 weeks
|
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.
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Day 1 and after 7 weeks
|
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Depression symptons
Time Frame: Day 1 and after 7 weeks
|
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.
|
Day 1 and after 7 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2022
Primary Completion (Actual)
May 10, 2022
Study Completion (Actual)
August 15, 2022
Study Registration Dates
First Submitted
November 29, 2022
First Submitted That Met QC Criteria
December 27, 2022
First Posted (Estimate)
December 29, 2022
Study Record Updates
Last Update Posted (Estimate)
December 29, 2022
Last Update Submitted That Met QC Criteria
December 27, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IPUBCDA
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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