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NCT Number: NCT06239740

Effects of Electroacupuncture on Cognitive Symptoms in Major Depressive Disorder

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.

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Key information

Conditions

Major Depressive Disorders Behavior Behavioral Symptoms Cognition Disorders Cognitive Dysfunction Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Neurocognitive Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Thammasat University

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: electroacupuncture

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Thai Patient Health Questionnaire (PHQ-9)

    Time frame: Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10)

    The Thai PHQ-9 (Patient Health Questionnaire-9) objectifies and assesses degree of depression severity via questionnaire. A lower score means better."

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Official study title

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

Acronym: ELECACU-COG-Pi

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 2, 2024
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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