NCT05667844

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 29, 2022

Completed
Last Updated

December 29, 2022

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

November 29, 2022

Last Update Submit

December 27, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    Day 1

  • 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.

    Day 1 and after 7 weeks

  • 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.

    Day 1 and after 7 weeks

Study Arms (1)

mind-body intervention

EXPERIMENTAL
Behavioral: interoceptive mind-body exercise

Interventions

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.

mind-body intervention

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with anxiety or/and depression clinical diagnosis
  • Participants who do not do formal meditation practices

You may not qualify if:

  • Participants with other diagnosis
  • Patients with cognitive conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio de Janeiro

Rio de Janeiro, 22290-140, Brazil

Location

MeSH Terms

Conditions

Mood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Study case
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master of science student

Study Record Dates

First Submitted

November 29, 2022

First Posted

December 29, 2022

Study Start

March 1, 2022

Primary Completion

May 10, 2022

Study Completion

August 15, 2022

Last Updated

December 29, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations