POWER project is a randomized, controlled, non-profit study with the primary objective of testing the effectiveness of non-pharmacological interventions-such as physical activity, cognitive training, and dietary supplementation-in reducing depressive symptoms and preventing or delaying cognitive impairments that frequently co-occur in individuals with Major Depressive Disorder (MDD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
3g/day of Soybean Oil
3 grams/day
Mind Body Interface Research Center (MBI Lab & Care)
Taichung, Taichung, Taiwan
RECRUITINGDepressive Symptoms
The 17-item version (HAMD-17) is used to quantify the severity of depression. A score of ≥18 shows a significant depression level.
Time frame: Weeks 0, 4, 8, 12, 16, 24
Depressive Symptoms
The GDS-15 (15-item Geriatric Depression Scale), a score of 5 or higher (≥5) indicates the presence of depression, or "clinically relevant" depressive symptoms.
Time frame: Weeks 0, 4, 8, 12, 16, 24
Depressive Symptoms
The 20-item Center for Epidemiological Studies Depression Scale (CES-D) to indicate significant, or "clinical," depressive symptoms is a total score higher than or equal to 16.
Time frame: Weeks 0, 4, 8, 12, 16, 24
Depressive Symptoms
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale with a total score range of 0 to 60, where higher scores indicate more severe depression.
Time frame: Weeks 0, 4, 8, 12, 16, 24
Executive Functioning
The Trail Making Test (TMT) evaluates cognitive impairment by measuring the time (in seconds) to complete tasks. Higher scores indicate slower, more impaired performance.
Time frame: Weeks 0, 4, 12, 24
Executive Functioning
Based on clinical literature, the Reliable Digit Span (RDS)-a raw score sum of the longest string of digits recalled forward and backward-is a common embedded measure of executive functioning and performance validity. Below 7 indicates a need for caution regarding the validity of the patient's cognitive effort or indicates a potential decline in working memory/attention.
Time frame: Weeks 0, 4, 12, 24
Executive Functioning
The Modified Wisconsin Card Sorting Test (M-WCST) assesses executive functioning, with higher scores indicating greater dysfunction or impairment.
Time frame: Weeks 0, 4, 12, 24
General Cognitive Ability and Memory & Attention
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) uses age-corrected index scores (Mean=100, SD=15) to identify cognitive impairment. Cutoff points for identifying impairment are set at 1 or 1.5 standard deviations (SD) below the mean.
Time frame: Weeks 0, 4, 12, 24
Processing Speed
Commonly used cut-off points for identifying cognitive impairment using the Digit Symbol Substitution Test (DSST) often fall within the range of lower than or equal to 25-35 points.
Time frame: Weeks 0, 4, 12, 24
Gut microbiome composition
Gut microbiota composition is primarily measured by analyzing microbial DNA extracted from fecal (stool) samples.
Time frame: Weeks 0 and 24
Fatty Acids Profiles in Blood
Fatty acid (FA) profiles in blood (red blood cells) are primarily measured using gas chromatography (GC).
Time frame: Weeks 0 and 24
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