Effects of Electroacupuncture on Cognitive Symptoms in Major Depressive Disorder (ELECACU-COG-Pi)

Thammasat University

Status: Completed

Conditions: Cognitive Dysfunction; Major Depressive Disorders

Treatments: Procedure: Electroacupuncture group; Procedure: Sham acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06239740

Thammasat University

MTU-EC-PS-1-304/64

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Electroacupuncture group

Experimental group

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.

Treatment:

Procedure: Electroacupuncture group

Sham acupuncture

Sham Comparator group

Description:

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

Treatment:

Procedure: Sham acupuncture