Effects of Electroacupuncture on Cognitive Symptoms in Major Depressive Disorder

Cognitive Dysfunction Clinical Trial

— ELECACU-COG-Pi  

Official title:

Effects of Electroacupuncture on Cognitive Symptoms in Major Depressive Disorder: A Pilot Study and Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06239740
• Other study ID #: MTU-EC-PS-1-304/64
• Secondary ID: Thammasat Univer
• Status: Completed
• Phase: N/A
• Start date: December 24, 2022
• Est. completion date: January 24, 2023

Study information

• Verified date: January 2024
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 24, 2023
• Est. primary completion date: January 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorders
• Neurobehavioral Manifestations

Intervention

Procedure:
• Electroacupuncture group
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 acupuncture
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

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Thammasat University	Khlong Luang	Pathum Thani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Secondary	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)