Mental Health Wellness 1NCT05081297
Qigong and Social Isolation: Mental Health Benefits
A study testing Qigong in people with Mental Health Wellness 1, run by Universidade do Porto at 1 site in Portugal.
Trial summary
The objective of the study is to understand if Qigong may be useful in controlling the psychological state of participants in relative social isolation (during Covid-19 governmental imposed isolation procedures) The sessions are conducted live by the internet by a professional instructor-therapist with the duration of… Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness 1
- What is being tested?
- Qigong
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePortugal
- Study dates
- 2 Jul 2020to 31 Oct 2020
- 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 16 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- -
Who cannot join
- Physical or mental disabilities or conditions that may aggravate when performing semi-supervised physical activity
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Instituto Português de Taichi e Chikung
Maia, Porto District, 4470-765
About this study
Official title: Qigong Effects on Mental Health of People Under Relative Isolation
The objective of the study is to understand if Qigong may be useful in controlling the psychological state of participants in relative social isolation (during Covid-19 governmental imposed isolation procedures) The sessions are conducted live by the internet by a professional instructor-therapist with the duration of 2 months and a regular minimum of 2 sessions a week.
Read the detailed description
The study's objective is to understand if Qigong may be helpful on the psychological state control of the participants in a relative state of isolation imposed by the government on the fight against Covid-19.
Data is gathered via the Mental Health Inventory (MHI) adapted to the Portuguese population to assess quantitative mental health scores and a simple structured interview to assess qualitative mental health benefits of Chikung (Qigong).
Qigong was the chosen technique to be studied as an intervention. Qigong is a Traditional Chinese Medicine therapeutic tool that has been studied for its several health benefits. As a traditional vegetative biofeedback therapy, Qigong can be useful for the maintenance of mental health of people with several conditions such as anxiety and depression, autism spectrum disorder and even conditions related to behavioral control.
- Group 1 was composed of Qigong practitioners (for at least 3 months).
- Group 2 was composed of participants who would receive the Qigong intervention (never practiced Qigong).
- Group 3 was composed of control participants (who would not receive the intervention).
- Conditions
- Mental Health Wellness 1
- Being tested
- Qigong
- Keywords
- Qigong, Mental health, social isolation, Traditional vegetative biofeedback therapy
- Medical subject headings
- Psychological Well-Being, Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QigongOther
Also called Traditional vegetative biofeedback therapy, Chikung, Taichi
Qigong as a traditional chinese medicine technique, composed of several types of exercises: Baduanjin, taijiquan, yijinjing, baojiangong.
| Study group | Role | What they receive |
|---|---|---|
| Qigong practitioner group | Experimental | This arm is the experimental group where qigong intervention is going to be applied to practitioners with experience Receives: Other: Qigong |
| No practice | No intervention | This group has no intervention and acts as control |
| Beginner Qigong practitioner group | Experimental | This arm is the experimental group where qigong intervention is going to be applied to practitioners with no experience. Receives: Other: Qigong |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Well-being (Mental health Inventory (MHI) dimension)
A higher score means a higher Psychological Well-being (0-100 score)
Measured: T0 - Baseline week 0
Psychological Well-being (Mental health Inventory (MHI) dimension)
A higher score means a higher Psychological Well-being (0-100 score)
Measured: T1 - 8 weeks
Psychological Distress (Mental health Inventory (MHI) dimension)
A higher score means a higher Psychological Distress (0-100 score)
Measured: T0 - Baseline week 0
Psychological Distress (Mental health Inventory (MHI) dimension)
A higher score means a higher Psychological Distress (0-100 score)
Measured: T1 - 8 weeks
Secondary outcomes (10)
Positive Affect (Mental health Inventory (MHI) dimension)
A higher score means a higher Positive Affect (0-100 score)
Measured: T0 - Baseline week 0
Positive Affect (Mental health Inventory (MHI) dimension)
A higher score means a higher Positive Affect (0-100 score)
Measured: T1 - 8 weeks
Emotional Ties (Mental health Inventory (MHI) dimension)
A higher score means higher Emotional Ties (0-100 score)
Measured: T0 - Baseline week 0
Emotional Ties (Mental health Inventory (MHI) dimension)
A higher score means higher Emotional Ties (0-100 score)
Measured: T1 - 8 weeks
Loss of emotional or behavioral control (Mental health Inventory (MHI) dimension)
A higher score means a higher Loss of emotional or behavioral control (0-100 score)
Measured: T0 - Baseline week 0
Loss of emotional or behavioral control (Mental health Inventory (MHI) dimension)
A higher score means a higher Loss of emotional or behavioral control (0-100 score)
Measured: T1 - 8 weeks
Anxiety (Mental health Inventory (MHI) dimension)
A higher score means higher Anxiety levels (0-100 score)
Measured: T0 - Baseline week 0
Anxiety (Mental health Inventory (MHI) dimension)
A higher score means higher Anxiety levels (0-100 score)
Measured: T1 - 8 weeks
Depression (Mental health Inventory (MHI) dimension)
A higher score means higher Depression levels (0-100 score)
Measured: T0 - Baseline week 0
Depression (Mental health Inventory (MHI) dimension)
A higher score means higher Depression levels (0-100 score)
Measured: T1 - 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start2 Jul 2020
- Primary completion30 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health Wellness 1Studies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jorge Pereira Machado, Universidade do Porto
- Investigators
- Jorge Machado, PhD, Study director, ICBAS - Instituto de Ciências Biomédicas Abel SalazarLara Lopes, MSc, Principal investigator, ICBAS - Instituto de Ciências Biomédicas Abel SalazarJorge M Rodrigues, BSc, Principal investigator, ICBAS - Instituto de Ciências Biomédicas Abel Salazar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081297
- Sponsor's protocol ID
- QgIsolationMentalHealth
- Status last verified
- Jan 2022
- First submitted
- 23 Sep 2021
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qigong Effects on Mental Health of People Under Relative Isolation
- ClinicalTrials.gov ID
- NCT05081297
- Acronym / sponsor ID
- QgIsolationMentalHealth
- Conditions
- Mental Health Wellness 1
- Keywords
- Qigong, Mental health, social isolation, Traditional vegetative biofeedback therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 18 Oct 2021 (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 objective of the study is to understand if Qigong may be useful in controlling the psychological state of participants in relative social isolation (during Covid-19 governmental imposed isolation procedures) The sessions are conducted live by the internet by a professional instructor-therapist with the duration of 2 months and a regular minimum of 2 sessions a week.
Detailed description
The study's objective is to understand if Qigong may be helpful on the psychological state control of the participants in a relative state of isolation imposed by the government on the fight against Covid-19.
Data is gathered via the Mental Health Inventory (MHI) adapted to the Portuguese population to assess quantitative mental health scores and a simple structured interview to assess qualitative mental health benefits of Chikung (Qigong).
Qigong was the chosen technique to be studied as an intervention. Qigong is a Traditional Chinese Medicine therapeutic tool that has been studied for its several health benefits. As a traditional vegetative biofeedback therapy, Qigong can be useful for the maintenance of mental health of people with several conditions such as anxiety and depression, autism spectrum disorder and even conditions related to behavioral control.
- Group 1 was composed of Qigong practitioners (for at least 3 months).
- Group 2 was composed of participants who would receive the Qigong intervention (never practiced Qigong).
- Group 3 was composed of control participants (who would not receive the intervention).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Qigong practitioner group | Experimental | Other: QigongThis arm is the experimental group where qigong intervention is going to be applied to practitioners with experience |
| No practice | No intervention | –This group has no intervention and acts as control |
| Beginner Qigong practitioner group | Experimental | Other: QigongThis arm is the experimental group where qigong intervention is going to be applied to practitioners with no experience. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- Physical or mental disabilities or conditions that may aggravate when performing semi-supervised physical activity
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 |
|---|---|---|
| QigongAlso: Traditional vegetative biofeedback therapy, Chikung, TaichiQigong as a traditional chinese medicine technique, composed of several types of exercises: Baduanjin, taijiquan, yijinjing, baojiangong. | Other | Beginner Qigong practitioner group, Qigong practitioner group |
Primary outcome
Psychological Well-being (Mental health Inventory (MHI) dimension)
Time frame: T0 - Baseline week 0
A higher score means a higher Psychological Well-being (0-100 score)
Psychological Well-being (Mental health Inventory (MHI) dimension)
Time frame: T1 - 8 weeks
A higher score means a higher Psychological Well-being (0-100 score)
Psychological Distress (Mental health Inventory (MHI) dimension)
Time frame: T0 - Baseline week 0
A higher score means a higher Psychological Distress (0-100 score)
Psychological Distress (Mental health Inventory (MHI) dimension)
Time frame: T1 - 8 weeks
A higher score means a higher Psychological Distress (0-100 score)
10 secondary outcomes
Positive Affect (Mental health Inventory (MHI) dimension)
Time frame: T0 - Baseline week 0
Positive Affect (Mental health Inventory (MHI) dimension)
Time frame: T1 - 8 weeks
Emotional Ties (Mental health Inventory (MHI) dimension)
Time frame: T0 - Baseline week 0
Emotional Ties (Mental health Inventory (MHI) dimension)
Time frame: T1 - 8 weeks
Loss of emotional or behavioral control (Mental health Inventory (MHI) dimension)
Time frame: T0 - Baseline week 0
Loss of emotional or behavioral control (Mental health Inventory (MHI) dimension)
Time frame: T1 - 8 weeks
Anxiety (Mental health Inventory (MHI) dimension)
Time frame: T0 - Baseline week 0
Anxiety (Mental health Inventory (MHI) dimension)
Time frame: T1 - 8 weeks
Depression (Mental health Inventory (MHI) dimension)
Time frame: T0 - Baseline week 0
Depression (Mental health Inventory (MHI) dimension)
Time frame: T1 - 8 weeks
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 11 Feb 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.
Jorge Machado, PhD study director
ICBAS - Instituto de Ciências Biomédicas Abel Salazar
Lara Lopes, MSc principal investigator
ICBAS - Instituto de Ciências Biomédicas Abel Salazar
Jorge M Rodrigues, BSc principal investigator
ICBAS - Instituto de Ciências Biomédicas Abel Salazar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qigong in people with Mental Health Wellness 1, run by Universidade do Porto at 1 site in Portugal.
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 1 inclusion and 1 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 11 Feb 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 Portugal. 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?
Psychological Well-being (Mental health Inventory (MHI) dimension) (time frame: T0 - Baseline week 0). The study lists 4 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 11 Feb 2022.