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Not yet recruiting NCT06852417

Qigong and Executive Attention in Older Adults with Depressive Symptoms

No phase Interventional Intervention Waitlist Control

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Health qigong training.
Who it may be relevant to
Registry conditions: Intervention, Waitlist Control. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Health Qigong Alleviates Depressive Symptoms in Older Adults Through Enhanced Executive Attention: a Randomized Controlled Trial

Overview

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.

Interventions

  • Behavioral 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,

Primary outcome measures

  • Executive attention [Time frame: Baseline and post-intervention (12 weeks after baseline)]
Secondary outcome measures (5)
  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06852417 · 15612625

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗