Mood DisordersNCT05667844
Effects of Mind-body Exercises in a Patient With Mood Disorders: a Case Study.
A study testing interoceptive mind-body exercise in people with Mood Disorders and Mind-body Exercise, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Mood Disorders, Mind-body Exercise
- What is being tested?
- interoceptive mind-body exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2022to 15 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants with anxiety or/and depression clinical diagnosis
- Participants who do not do formal meditation practices
Who cannot join
- Participants with other diagnosis
- Patients with cognitive conditions
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Mood Disorders, Mind-body Exercise
- Being tested
- interoceptive mind-body exercise
- Medical subject headings
- Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interoceptive mind-body exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| mind-body intervention | Experimental | Not described Receives: Behavioral: interoceptive mind-body exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 1 and after 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start1 Mar 2022
- Primary completion10 May 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study case
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karoline Almeida Pereira, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05667844
- Sponsor's protocol ID
- IPUBCDA
- Status last verified
- Dec 2022
- First submitted
- 29 Nov 2022
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mind-body Exercises in a Patient With Mood Disorders: a Case Study.
- ClinicalTrials.gov ID
- NCT05667844
- Acronym / sponsor ID
- IPUBCDA
- Conditions
- Mood Disorders, Mind-body Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 29 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study case
| Arm | Type | Receives |
|---|---|---|
| mind-body intervention | Experimental | Behavioral: interoceptive mind-body exercise |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Participants with anxiety or/and depression clinical diagnosis
- Participants who do not do formal meditation practices
Key exclusion criteria (2 listed)
- Participants with other diagnosis
- Patients with cognitive conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interoceptive mind-body exerciseA 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. | Behavioural | mind-body intervention |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interoceptive mind-body exercise in people with Mood Disorders and Mind-body Exercise, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mnteroceptive capacity (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.