Clinical trial NCT06239740: Effects of Electroacupuncture on Cognitive Symptoms in Major Depressive Disorder
Official title: Effects of Electroacupuncture on Cognitive Symptoms in Major Depressive Disorder: A Pilot Study and Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorders
Cognitive Dysfunction
Keywords: Electroacupuncture
Depression
Cognition
Humans
Pilot
Randomized Controlled Trial
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2024-02-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Trail making test B (TMT-B)
timeFrame: Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10)
measure: The Stroop Color and Word Test (SCWT)
timeFrame: Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10)
measure: ADAS-cog category delayed recall
timeFrame: Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10)
measure: Subjective cognitive complaint
timeFrame: Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10)
Secondary outcomes:
measure: Thai Patient Health Questionnaire (PHQ-9)
timeFrame: Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10)
Other outcomes:
Locations:
city: Khlong Luang
country: Thailand
facility: Faculty of Medicine, Thammasat University
state: Pathum Thani
Study officials:
References: