Major Depressive DisordersELECACU-COG-PiNCT06239740
Effects of Electroacupuncture on Cognitive Symptoms in Major Depressive Disorder
A study testing Electroacupuncture group in people with Major Depressive Disorders and Cognitive Dysfunction, run by Thammasat University at 1 site in Thailand.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Major Depressive Disorders, Cognitive Dysfunction
- What is being tested?
- Electroacupuncture group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 24 Dec 2022to 24 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged between 18 and 55 years
- MDD diagnosed according to the DSM-5 or DSM-IV-TR criteria,
- low suicidal risk
- receiving treatment with antidepressants for at least 3 months from psychiatrists and psychiatric residents.
- Subjective cognitive symptoms from the screening using the Thai version of the Patient Health Questionnaire (Thai-PHQ-9).
Who cannot join
- severe cognitive deficits from traumatic brain injury, delirium, neurodevelopmental disorders, or intellectual disability;
- neurological disorders such as stroke, Parkinson's disease, epilepsy, or other brain lesions;
- severe medical conditions preventing lying down for 20 minutes;
- recent electroconvulsive therapy (ECT) within the last 6 months;
- Individuals with a pacemaker;
- visual or hearing impairment that could not be corrected with eyeglasses or hearing aids;
- severe MDD or scoring 20 points or more on the Thai-PHQ-9.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Thammasat University
Khlong Luang, Changwat Pathum Thani, 12120
About this study
Official title: Effects of Electroacupuncture on Cognitive Symptoms in Major Depressive Disorder: A Pilot Study and Randomized Controlled Trial
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:
Read more
- Primary : electroacupuncture has the potential to treat subjective cognitive complaints and cognitive impairment in MDD outpatients
- Secondary : electroacupuncture has the potential to treat depressive in MDD outpatients The 60 participants will randomly be assigned to either the treatment group or the control group in a 1:1 ratio. The treatment group will undergo electroacupuncture (EA), while the control group will receive sham acupuncture within 10 weeks period.
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.
- Conditions
- Major Depressive Disorders, Cognitive Dysfunction
- Being tested
- Electroacupuncture group, Sham acupuncture
- Keywords
- Electroacupuncture, Depression, Cognition, Humans, Pilot, Randomized Controlled Trial
- Medical subject headings
- Depressive Disorder, Major, Cognitive Dysfunction, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroacupuncture groupProcedure or surgery
Also called electroacupuncture
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.
Sham acupunctureProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Electroacupuncture group |
| 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 Receives: Procedure: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10)
Secondary outcomes (1)
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."
Measured: Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start24 Dec 2022
- Primary completion24 Jan 2023
- Study completion24 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yindee Boontra, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239740
- Sponsor's protocol ID
- MTU-EC-PS-1-304/64
- Other IDs
- Thammasat University
- Acronym
- ELECACU-COG-Pi
- Status last verified
- Jan 2024
- First submitted
- 12 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data set will be share on Zenodo
Publications
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.
PubMed 39620153
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Electroacupuncture on Cognitive Symptoms in Major Depressive Disorder: A Pilot Study and Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06239740
- Acronym / sponsor ID
- ELECACU-COG-Pi / MTU-EC-PS-1-304/64
- Conditions
- Major Depressive Disorders, Cognitive Dysfunction
- Keywords
- Electroacupuncture, Depression, Cognition, Humans, Pilot, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 24 Dec 2022 (actual)
- Primary completion
- 24 Jan 2023 (actual)
- Study completion
- 24 Jan 2023 (actual)
- First posted
- 2 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Primary : electroacupuncture has the potential to treat subjective cognitive complaints and cognitive impairment in MDD outpatients
- Secondary : electroacupuncture has the potential to treat depressive in MDD outpatients The 60 participants will randomly be assigned to either the treatment group or the control group in a 1:1 ratio. The treatment group will undergo electroacupuncture (EA), while the control group will receive sham acupuncture within 10 weeks period.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture group | Experimental | Procedure: Electroacupuncture groupIn 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. |
| Sham acupuncture | Sham comparator | Procedure: Sham acupunctureIn 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- aged between 18 and 55 years
- MDD diagnosed according to the DSM-5 or DSM-IV-TR criteria,
- low suicidal risk
- receiving treatment with antidepressants for at least 3 months from psychiatrists and psychiatric residents.
- Subjective cognitive symptoms from the screening using the Thai version of the Patient Health Questionnaire (Thai-PHQ-9).
Key exclusion criteria (7 listed)
- severe cognitive deficits from traumatic brain injury, delirium, neurodevelopmental disorders, or intellectual disability;
- neurological disorders such as stroke, Parkinson's disease, epilepsy, or other brain lesions;
- severe medical conditions preventing lying down for 20 minutes;
- recent electroconvulsive therapy (ECT) within the last 6 months;
- Individuals with a pacemaker;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electroacupuncture groupAlso: electroacupunctureThe 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. | Procedure or surgery | Electroacupuncture group |
| Sham acupunctureparticipants 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 | Procedure or surgery | Sham acupuncture |
Primary outcome
Trail making test B (TMT-B)
Time frame: Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10)
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.
The Stroop Color and Word Test (SCWT)
Time frame: Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10)
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.
ADAS-cog category delayed recall
Time frame: Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10)
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.
Subjective cognitive complaint
Time frame: Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10)
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.
1 secondary outcome
Thai Patient Health Questionnaire (PHQ-9)
Time frame: Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Derived from this study: PubMed 39620153Boontra 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.
- Individual participant dataSharing planned: Yes. The data set will be share on Zenodo
Related trials for Major Depressive Disorders
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture group in people with Major Depressive Disorders and Cognitive Dysfunction, run by Thammasat University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trail making test B (TMT-B) (time frame: Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06239740, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.