Effects of Electroacupuncture on Cognitive Symptoms in Major Depressive Disorder

NCT06239740 | Completed

• 2 other identifiers: MTU-EC-PS-1-304/64Thammasat University
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorders; Cognitive Dysfunction

Keywords

Electroacupuncture; Depression; Cognition; Humans; Pilot; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (1)

• Thai Patient Health Questionnaire (PHQ-9)

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

Study Arms (2)

Electroacupuncture group

EXPERIMENTAL

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

Sham acupuncture

SHAM COMPARATOR

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

Interventions

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.

Also known as: electroacupuncture

Electroacupuncture group

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

Sham acupuncture

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (1)

Faculty of Medicine, Thammasat University

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

Location

Related Publications (1)

• Boontra Y, Thanetnit C, Phanasathit M. Effects of electroacupuncture on cognitive symptoms in major depressive disorder: a pilot study and randomized controlled trial. F1000Res. 2024 Dec 23;13:479. doi: 10.12688/f1000research.146897.4. eCollection 2024.

  PMID: 39620153 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Cognitive Dysfunction; Depression

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: February 2, 2024
• Study Start: December 24, 2022
• Primary Completion: January 24, 2023
• Study Completion: January 24, 2023
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: January 15, 2024 and for 5 years (Jan 14, 2029)
• Access Criteria: no limitation

Locations

TH (1)