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

January 25, 2024 updated by: Yindee Boontra, Thammasat University

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:

  • 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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Pathum Thani
      • Khlong Luang, Pathum Thani, Thailand, 12120
        • Faculty of Medicine, Thammasat University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electroacupuncture group
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.
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.
Other Names:
  • electroacupuncture
Sham Comparator: Sham acupuncture
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
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10)
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.
Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10)
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.
Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10)
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.
Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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."
Pre-intervention at the beginning point (T0) and the endpoint will be the 10th week (T10)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2022

Primary Completion (Actual)

January 24, 2023

Study Completion (Actual)

January 24, 2023

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 25, 2024

First Posted (Actual)

February 2, 2024

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTU-EC-PS-1-304/64
  • Thammasat University (Other Identifier: Faculty of Medicine, Thammasat University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data set will be share on Zenodo

IPD Sharing Time Frame

January 15, 2024 and for 5 years (Jan 14, 2029)

IPD Sharing Access Criteria

no limitation

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Study Data/Documents

  1. Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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