- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06852417
Qigong and Executive Attention in Older Adults with Depressive Symptoms
February 27, 2025 updated by: LU Yiqing Erin, The Hong Kong Polytechnic University
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).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- (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.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Baduanjin
This arm is for intervention group who will receive health qigong training.
|
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.
|
|
No Intervention: Waitlist control
The arm is for control group who will not receive any training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and post-intervention (12 weeks after baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive symptoms
Time Frame: Baseline and post-intervention (12 weeks after baseline)
|
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.
|
Baseline and post-intervention (12 weeks after baseline)
|
|
Amplitude of N2 component
Time Frame: Baseline and post-intervention (12 weeks after baseline)
|
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).
|
Baseline and post-intervention (12 weeks after baseline)
|
|
Amplitude of P3 component
Time Frame: Baseline and post-intervention (12 weeks after baseline)
|
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).
|
Baseline and post-intervention (12 weeks after baseline)
|
|
Alerting
Time Frame: Baseline and post-intervention (12 weeks after baseline)
|
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.
|
Baseline and post-intervention (12 weeks after baseline)
|
|
Orienting
Time Frame: Baseline and post-intervention (12 weeks after baseline)
|
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.
|
Baseline and post-intervention (12 weeks after baseline)
|
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 (Estimated)
January 1, 2026
Primary Completion (Estimated)
October 31, 2028
Study Completion (Estimated)
December 31, 2028
Study Registration Dates
First Submitted
February 24, 2025
First Submitted That Met QC Criteria
February 24, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 27, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15612625
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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