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Trial · NCT05595421

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryThe change over time in the score of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups)Six weeks
The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is a 10-item scale designed to measure the severity and type of symptoms in people with obsessive-compulsive disorder (OCD) over the past seven days. The symptoms assessed are obsessions and compulsions. Total Y-BOCS scores range from 0 to 40, with higher scores indicating greater severity of OCD symptoms. Scores on the obsession and compulsion subscales range from 0 to 20, but only the total Y-BOCS score is interpreted.
SecondaryThe change over time in the score of self-reporting OCD Visual Analog Scale (OCD-VAS) (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups)Six weeksThe participants use the self-reporting OCD Visual Analog Scale (OCD-VAS) to rate on a 10-point scale the current obsessive and compulsive symptoms (0 = Feel Worst Ever to 10 = Feel Best Ever).
Secondary
The change over time in the score of the Clinical Global Impression improvement (CGI-I) subscales of the CGI-S (severity scale) (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups)
Six weeks
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Clinicians ask: "Compared to the patient's condition at baseline, this patient's average condition is rated as from 1 (Very much improved) to 7 (Very much worse).
SecondaryThe change over time in the score of Hamilton Depression Rating Scale (HAM-D) (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups)Six weeks
The HAMD is designed to be administered by a trained clinician, and it contains 17 items rated on either a 3- or 5-point scale, with the sum of all items making up the total score. Low scores indicate less depression severity and greater function.
SecondaryThe change over time in the score of Hamilton Anxiety Rating Scale (HAM-A) (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups)Six weeksThe total score of HAMA ranges from 0-56, with each of the 14 items being scored on a severity scale of 0 to 4. Low scores indicate less anxiety severity and greater function.
Secondary
The change over time in the score of the Taiwanese version of World Health Organization Quality of Life-BREF (from baseline to the timepoints immediately after intervention, at one-week and one-month follow-ups)
Six weeks
The Taiwanese version of World Health Organization Quality of Life-BREF is a self-report 28 items (2 generic, 7 Physical, 6 Psychological, 4 Social, and 9 Environment items) questionnaire. Item scores range from 1 (the worst condition) to 5 (the best condition), except for 3 items (Ph1, Ph2, and Ps6), which are reverse coded. A higher score indicates better quality of Life.
SecondaryThe changes over time in the results of Continuous Performance (CPT, version 2.0) (from baseline to the end of intervention)Two weeksA neuropsychological test that examines the performance of prefrontal-mediated task
SecondaryThe changes over time in the results of Color Trails Test (CTT) (from baseline to the end of intervention)Two weeks
The CTT, a culture-neutral version of the Trail Making Test, was selected to measure sustained visual attention. The CTT consists of two parts (CTT-1 and CTT-2). The CTT-1 requires participants to connect a series of numbered circles that are randomly printed on a sheet of paper. In the CTT-2, numbered circles of 1 to 25 are shown twice (printed in pink and in yellow) randomly on a sheet of paper. Participants are asked to connect the numbers from 1 to 25 alternating between the two colors.
SecondaryThe changes over time in the results of Stroop Color Word Test (SCWT) (from baseline to the end of intervention)Two weeksStroop Color Word Test (SCWT), Chinese version; was administered to measure selective attention and cognitive flexibility. SCWT is composed of three parts, each lasting for 45 seconds.
SecondaryThe changes over time in the results of Tower of London test (from baseline to the end of intervention)Two weeksA neuropsychological test for the assessment of executive functioning specifically to detect deficits in planning, which may occur due to a variety of medical and neuropsychiatric conditions.
SecondaryThe change over time in the score of the Digit Symbol Substitution Test (DSST) (from baseline to the end of intervention)Two weeks
DSST is a performance based test of cognitive performance tapping into processing speed, executive function, and attention, with 90 s test period and possible score range 0 133 (See detail in the DSST manual attached).
SecondaryThe changes over time in indices of heart rate variability (HRV) (from baseline to the end of intervention)Two weeks
HRV indices represent autonomic functioning. ECG electrodes were placed on bilateral arms just below the elbows, with a ground electrode placed just above the right wrist bone. Lead I electrocardiogram of each patient was taken for 5 min after sitting and having a rest for 20 min in a soundproof, dim-lighted room with thermostatic control. At baseline and the end of intervention, HRV will be collected during rest. The ECG signals were acquired, stored, pre-processed according to the recommended procedures and processed by an HRV analyser (LR8Z11, Yangyin Corp., Taipei, Taiwan). The time domain of HRV is obtained: Standard deviation of NN intervals (SDNN). Power spectrum of HRV is quantified into the standard frequency-domain measurements including low-frequency power (LF, 0.04-0.15 Hz), high-frequency power (HF, 0.15- 0.40 Hz).
SecondaryThe changes over time in EEG absolute power and coherence (from baseline to the end of intervention)Two weeks
In a recliner in a dimly lit, electrically shielded room, patients' EEGs were recorded at baseline and the end of intervention by using the Neuro Prax® TMS/tDCS full-band DC-EEG system with 32 EEG Ag/AgCl electrodes in the standard 10-20 International placement. EEG will be collected during resting eye-opened (5min) and eye-closed (5min) conditions. Signals will be amplified in the dynamic input range of ± 140 mV at a resolution of 0.5 μV by using EEG amplifiers and stored for offline analyses. Eye or muscle artifacts were automatically detected and removed using NeuroPrax's built-in software.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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