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| ID | Type | Description | Link |
|---|---|---|---|
| Thammasat University | Other Identifier | Faculty of Medicine, Thammasat University |
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The goal of this pilot Study and Randomized Controlled Trial is to investigate the impact of electroacupuncture on cognitive function, quality of life (QoL), and depression severity in patients with major depressive disorder (MDD).
The main question[s] it aims to answer are:
Both groups will receive antidepressants with adjunctive medication (i.e., benzodiazepines, tricyclics, or antipsychotics) as the standard treatment. All participants will be assessed for executive functions and memory using specific cognitive tests, including the Trail Making Test B (TMT-B), Stroop Color and Word Test (SCWT), category delayed recall in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), and subjective reports of concern regarding concentration, memory, problem-solving, learning, communication, and quality of life (QoL) concerns using the WHO Disability Assessment Schedule (WHODAS 2.0; sections D1.1-1.6 and H1-3), and depressive symptoms were assessed using the Thai-PHQ-9.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroacupuncture group | Experimental | In the electroacupuncture group (EG), participants received acupuncture at 10 scalp points (Baihui [GV20], Ex-hn 1, 3 points of intelligence [Shenting [GV24], Benshen [GB13] on both sides, Touwei [ST8] on both sides). Electroacupuncture was applied for 20 minutes at Benshen [GB13] and Touwei [ST8] on both sides. They also received acupuncture at Tai chong [LV3], Tai Yuan [LU9], and Tai Xi [KI3] on both sides, as shown in picture 1. Acupuncture sessions were weekly for 10 weeks.](streamdown:incomplete-link) |
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| Sham acupuncture | Sham Comparator | In the sham acupuncture control group (CG), participants received acupress or a brief needle insertion at He gu on both hands during the first and 10th weeks, marking the endpoint of the study |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroacupuncture group | Procedure | The acupuncture needle was placed on the scalp at a Chinese traditional acupuncture point. Subsequently, a small electrode was attached to the needle. A minor amount of electricity runs through the electrode, producing a slight vibration or soft hum during the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Trail making test B (TMT-B) | The TMT- B is scored based on the time (in seconds) it takes to complete the test, including corrections for errors prompted by the examiner. A shorter time implies better performance. | Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10) |
| The Stroop Color and Word Test (SCWT) | SCWT used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute."Score" refers to the number of words achieved, and a higher number of words indicates a better score. | Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10) |
| ADAS-cog category delayed recall | ADAS-cog category delayed recall is used to assess memory. The score reflects the number of words that can be remembered. The more words remembered, the better the score. | Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10) |
| Subjective cognitive complaint | WHODAS 2.0; sections D1.1-1.6 and H1-3, which is a questionnaire asking about the number of days in the past 30 days when participants experienced difficulties with attention, understanding, and initiating conversation. "Score" is the rating of the number of days with issues, and a decrease in score indicates improvement or a better outcome. | Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10) |
| Measure | Description | Time Frame |
|---|---|---|
| Thai Patient Health Questionnaire (PHQ-9) | The Thai PHQ-9 (Patient Health Questionnaire-9) objectifies and assesses degree of depression severity via questionnaire. A lower score means better." | Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Thammasat University | Khlong Luang | Changwat Pathum Thani | 12120 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39620153 | Derived | Boontra Y, Thanetnit C, Phanasathit M. Effects of electroacupuncture on cognitive symptoms in major depressive disorder: a pilot study and randomized controlled trial. F1000Res. 2024 Dec 23;13:479. doi: 10.12688/f1000research.146897.4. eCollection 2024. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
The data set will be share on Zenodo
January 15, 2024 and for 5 years (Jan 14, 2029)
no limitation
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D060825 | Cognitive Dysfunction |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
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In the electroacupuncture group (EG), participants received acupuncture at 10 scalp points (Baihui [GV20], Ex-hn 1, 3 points of intelligence [Shenting [GV24], Benshen [GB13] on both sides, Touwei [ST8] on both sides). Electroacupuncture was applied for 20 minutes at Benshen [GB13] and Touwei [ST8] on both sides. They also received acupuncture at Tai chong [LV3], Tai Yuan [LU9], and Tai Xi [KI3] on both sides, as shown in picture 1. Acupuncture sessions were weekly for 10 weeks.
In the sham acupuncture control group (CG), participants received acupress or a brief needle insertion at He gu on both hands during the first and 10th weeks, marking the endpoint of the study.](streamdown:incomplete-link)
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In the sham acupuncture control group (CG), participants received acupress or a brief needle insertion at He gu on both hands during the first and 10th weeks, marking the endpoint of the study.
|
|
| Sham acupuncture | Procedure | participants received acupress or a brief needle insertion at He gu on both hands during the first and 10th weeks, marking the endpoint of the study |
|
| D019965 |
| Neurocognitive Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D004599 |
| Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |