InterventionNCT06852417
Qigong and Executive Attention in Older Adults with Depressive Symptoms
A study testing Health qigong training in people with Intervention and Waitlist Control, run by The Hong Kong Polytechnic University.
Trial summary
The goal of this randomized controlled trial is to test whether executive attention unpacks the antidepressant effect of Baduanjin (a form of health qigong) in older adults. The main questions it aims to answer are: Is Baduanjin an effective treatment to enhance executive attention in older adults with depressive… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intervention, Waitlist Control
- What is being tested?
- Health qigong training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- have mild or severer levels of depressive symptoms, as indicated by Geriatric Depression Scale scores of 5 or above or Depression Anxiety and Stress Scale-21 depression subscale scores of 4 or above
- self-identified as physically stable and without life-threatening diseases
- be able to communicate in Cantonese or Mandarin.
Who cannot join
- (have a history of practicing or receiving training in any form of mind-body or regular exercises (including tai chi, yoga, and qigong or regular physical activity > 3 times/week) during the month prior to recruitment
- have changed medications or the dose of medications prescribed for their health condition in the month prior to study enrollment
- have a severe cognitive or language impairment, as indicated by a score of less than 21 on the Montreal Cognitive Assessment
- receiving pharmacological treatment, electroconvulsive therapy, psychotherapy, or psychoeducation for any psychological or psychiatric condition upon the time of recruitment
- be unable to demonstrate satisfactory standing balance.
About this study
Official title: Health Qigong Alleviates Depressive Symptoms in Older Adults Through Enhanced Executive Attention: a Randomized Controlled Trial
The goal of this randomized controlled trial is to test whether executive attention unpacks the antidepressant effect of Baduanjin (a form of health qigong) in older adults.
The main questions it aims to answer are:
- Is Baduanjin an effective treatment to enhance executive attention in older adults with depressive symptoms?
- Does Baduanjin work through enhanced executive attention to alleviate depressive symptoms in older adults? Researchers will compare Baduanjin with waitlist control. Participants will receive 12-week Baduanjin training (two sessions per week and 60 min per session).
Read the detailed description
Baduanjin is a type of health qigong that has been shown to effectively reduce depressive symptoms in older adults. However, the cognitive mechanism that explains such antidepressant effect remains unclear. Executive attention represents the cognitive processing that deals with interference and conflict, and it is likely to be a mechanism to unpack Baduanjin's treatment effect on depressive symptoms. There is also a lack of understanding of Badunajin's effects on brain activation in depressed older adults. To address these knowledge gaps, we propose a fully powered randomized controlled trial (RCT) with 198 older adults with at least mild depressive symptoms. They will be randomly assigned to either the active intervention group (12-week Baduanjin training) or the waitlist control group. The primary outcome is executive attention. Secondary outcomes include depressive symptoms, amplitudes of N2 and P3 components (i.e., components of event-related potentials in brain) during attention tasks, and alerting and orienting networks of attention. These outcomes will be assessed at baseline and post-intervention (12 weeks after baseline). Repeated measures ANOVA will be used to test for treatment effects on the primary outcome. Executive attention's mediation effect on the linkage between group (intervention vs waitlist control) and depressive symptoms will be tested with SPSS Macro PROCESS. The Baduanjin-related enhancement in N2 amplitude, P3 amplitude, alerting, and orienting will be explored with repeated measures ANOVA, respectively. Correlation analyses will be used to evaluate the association (i) between changes in N2 and P3 amplitudes and changes in executive attention and (ii) between changes in N2 and P3 amplitudes and changes in depressive symptoms.
- Conditions
- Intervention, Waitlist Control
- Being tested
- Health qigong training
- Keywords
- Health qigong, Baduanjin, executive attention, depressive symptoms
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health qigong trainingBehavioural
Participants will receive two 60-minute Baduanjin qigong training sessions every week under the instruction and supervision of qualified qigong instructors over 12 weeks (i.e., 24 sessions in total). Baduanjin qigong consists of eight forms of gentle movements, and it takes about 10 to 15 minutes to complete a full cycle. Participants will learn to practice each form gradually over the first 12 sessions. In the remaining 12 sessions, the participants will go through all the movements 2-3 times, with guided practice on rhythmic breathing and mind regulation (attention to body and breathing) to be performed in coordination with the movements. Instructions on each movement, voice-guide audios, and demonstration videos will be provided for participants' daily self-practice. They will be advised to practice Baduanjin for at least 10 minutes every day.
| Study group | Role | What they receive |
|---|---|---|
| Baduanjin | Experimental | This arm is for intervention group who will receive health qigong training. Receives: Behavioral: Health qigong training |
| Waitlist control | No intervention | The arm is for control group who will not receive any training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive attention
The Attention Network Test (ANT) will be used to assess executive attention. The ANT is a computer-based test based on a combination of Posner's cueing task and the Flanker task. Executive attention will be operationalized as the difference in reaction time (measured in ms) in congruent and incongruent trials.
Measured: Baseline and post-intervention (12 weeks after baseline)
Secondary outcomes (5)
Depressive symptoms
The 8-item Patient Health Questionnaire (PHQ) will be used to assess depressive symptoms. It includes eight items assessing the frequency of depressive symptoms over the previous two weeks on a 4-point scale (0 = never, 3 = almost every day). The total score ranges from 0 to 24, with a higher score indicating a greater severity of depressive symptoms.
Measured: Baseline and post-intervention (12 weeks after baseline)
Amplitude of N2 component
Participants' neurophysiological activity during The Attention Network Test (ANT) will be recorded with a dry electroencephalography (EEG) device, DSI-24 with 21 electrodes. N2 amplitude will be calculated by averaging the amplitudes recorded at the selected electrodes and time windows (210-350 ms).
Measured: Baseline and post-intervention (12 weeks after baseline)
Amplitude of P3 component
Participants' neurophysiological activity during The Attention Network Test (ANT) will be recorded with a dry electroencephalography (EEG) device, DSI-24 with 21 electrodes. P3 amplitude will be calculated by averaging the amplitudes recorded at the selected electrodes and time windows (350-550 ms).
Measured: Baseline and post-intervention (12 weeks after baseline)
Alerting
The Attention Network Test (ANT) will be used to assess alerting. The ANT is a computer-based test based on a combination of Posner's cueing task and the Flanker task. Alerting will be operationalized as the difference in reaction time in no cue trials and center cue trials.
Measured: Baseline and post-intervention (12 weeks after baseline)
Orienting
The Attention Network Test (ANT) will be used to assess orienting. The ANT is a computer-based test based on a combination of Posner's cueing task and the Flanker task. Orienting will be operationalized as the difference in reaction time in center cue trials and spatial cue trials.
Measured: Baseline and post-intervention (12 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InterventionStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LU Yiqing Erin, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852417
- Sponsor's protocol ID
- 15612625
- Status last verified
- Feb 2025
- First submitted
- 24 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Qigong Alleviates Depressive Symptoms in Older Adults Through Enhanced Executive Attention: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06852417
- Acronym / sponsor ID
- 15612625
- Conditions
- Intervention, Waitlist Control
- Keywords
- Health qigong, Baduanjin, executive attention, depressive symptoms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Feb 2025 (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 goal of this randomized controlled trial is to test whether executive attention unpacks the antidepressant effect of Baduanjin (a form of health qigong) in older adults.
The main questions it aims to answer are:
- Is Baduanjin an effective treatment to enhance executive attention in older adults with depressive symptoms?
- Does Baduanjin work through enhanced executive attention to alleviate depressive symptoms in older adults? Researchers will compare Baduanjin with waitlist control. Participants will receive 12-week Baduanjin training (two sessions per week and 60 min per session).
Detailed description
Baduanjin is a type of health qigong that has been shown to effectively reduce depressive symptoms in older adults. However, the cognitive mechanism that explains such antidepressant effect remains unclear. Executive attention represents the cognitive processing that deals with interference and conflict, and it is likely to be a mechanism to unpack Baduanjin's treatment effect on depressive symptoms. There is also a lack of understanding of Badunajin's effects on brain activation in depressed older adults. To address these knowledge gaps, we propose a fully powered randomized controlled trial (RCT) with 198 older adults with at least mild depressive symptoms. They will be randomly assigned to either the active intervention group (12-week Baduanjin training) or the waitlist control group. The primary outcome is executive attention. Secondary outcomes include depressive symptoms, amplitudes of N2 and P3 components (i.e., components of event-related potentials in brain) during attention tasks, and alerting and orienting networks of attention. These outcomes will be assessed at baseline and post-intervention (12 weeks after baseline). Repeated measures ANOVA will be used to test for treatment effects on the primary outcome. Executive attention's mediation effect on the linkage between group (intervention vs waitlist control) and depressive symptoms will be tested with SPSS Macro PROCESS. The Baduanjin-related enhancement in N2 amplitude, P3 amplitude, alerting, and orienting will be explored with repeated measures ANOVA, respectively. Correlation analyses will be used to evaluate the association (i) between changes in N2 and P3 amplitudes and changes in executive attention and (ii) between changes in N2 and P3 amplitudes and changes in depressive symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baduanjin | Experimental | Behavioral: Health qigong trainingThis arm is for intervention group who will receive health qigong training. |
| Waitlist control | No intervention | –The arm is for control group who will not receive any training. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- have mild or severer levels of depressive symptoms, as indicated by Geriatric Depression Scale scores of 5 or above or Depression Anxiety and Stress Scale-21 depression subscale scores of 4 or above
- self-identified as physically stable and without life-threatening diseases
- be able to communicate in Cantonese or Mandarin.
Key exclusion criteria (5 listed)
- (have a history of practicing or receiving training in any form of mind-body or regular exercises (including tai chi, yoga, and qigong or regular physical activity > 3 times/week) during the month prior to recruitment
- have changed medications or the dose of medications prescribed for their health condition in the month prior to study enrollment
- have a severe cognitive or language impairment, as indicated by a score of less than 21 on the Montreal Cognitive Assessment
- receiving pharmacological treatment, electroconvulsive therapy, psychotherapy, or psychoeducation for any psychological or psychiatric condition upon the time of recruitment
- be unable to demonstrate satisfactory standing balance.
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 |
|---|---|---|
| Health qigong trainingParticipants will receive two 60-minute Baduanjin qigong training sessions every week under the instruction and supervision of qualified qigong instructors over 12 weeks (i.e., 24 sessions in total). Baduanjin qigong consists of eight forms of gentle movements, and it takes about 10 to 15 minutes to complete a full cycle. Participants will learn to practice each form gradually over the first 12 sessions. In the remaining 12 sessions, the participants will go through all the movements 2-3 times, with guided practice on rhythmic breathing and mind regulation (attention to body and breathing) to be performed in coordination with the movements. Instructions on each movement, voice-guide audios, and demonstration videos will be provided for participants' daily self-practice. They will be advised to practice Baduanjin for at least 10 minutes every day. | Behavioural | Baduanjin |
Primary outcome
Executive attention
Time frame: Baseline and post-intervention (12 weeks after baseline)
The Attention Network Test (ANT) will be used to assess executive attention. The ANT is a computer-based test based on a combination of Posner's cueing task and the Flanker task. Executive attention will be operationalized as the difference in reaction time (measured in ms) in congruent and incongruent trials.
5 secondary outcomes
Depressive symptoms
Time frame: Baseline and post-intervention (12 weeks after baseline)
Amplitude of N2 component
Time frame: Baseline and post-intervention (12 weeks after baseline)
Amplitude of P3 component
Time frame: Baseline and post-intervention (12 weeks after baseline)
Alerting
Time frame: Baseline and post-intervention (12 weeks after baseline)
Orienting
Time frame: Baseline and post-intervention (12 weeks after baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Health qigong training in people with Intervention and Waitlist Control, run by The Hong Kong Polytechnic University.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Executive attention (time frame: Baseline and post-intervention (12 weeks after baseline)). 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 3 Mar 2025.