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Published on: February 13, 2020
Protocol for a feasibility trial of digital mindfulness and cognitive-motor exercise for subclinical depression in
Haifeng Zhang1, Caixia Xie1, Mang Zhang1
1Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, China.
Objective:
Subclinical depression in older adults, though below the diagnostic threshold for major depressive disorder (MDD), is associated with an increased risk of progression and functional decline. This study aims to assess the feasibility, safety, and preliminary efficacy of a combined mindfulness-based and cognitive-motor intervention, with a view to future optimization and broader application.
Methods:
This single-arm design study will involve older adults with subclinical depression aged 60 years and above. Participants will undergo an 8-week intervention combining mindfulness practices and cognitive-motor exercises. The primary outcomes will be feasibility and adherence to the intervention, and the secondary outcomes will be depressive and anxiety symptoms, cognitive function, activities of daily living, and safety. Additional secondary outcomes will be brain magnetic resonance imaging (MRI) findings and serum cortisol levels.
Results:
We anticipate high feasibility and adherence, with minimal adverse events. Improvements are expected in depressive and anxiety symptoms, cognition, and function, along with reduced cortisol levels. MRI may reveal structural and functional changes in brain regions associated with emotional regulation and cognition. Findings will inform the development of scalable digital interventions.
Conclusion:
This study will provide initial evidence on the utility of integrating mindfulness and cognitive-motor approaches for older adults with subclinical depression. The results will support the design of accessible, non-pharmacological strategies that can be digitally delivered to enhance mental health in aging populations.
Trial Status:
The study is currently ongoing (identifier: ChiCTR2400087251).
