Effects of Electroacupuncture on Cognitive Symptoms in Major Depressive Disorder

NCT ID: NCT06239740

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-24
• Study Completion Date: 2023-01-24

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Electroacupuncture group

Intervention Type: 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.

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

Group Type: SHAM_COMPARATOR

Sham acupuncture

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: PROCEDURE

Other Intervention Names

electroacupuncture

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thammasat University

OTHER

Sponsor Role: lead

Responsible Party

Yindee Boontra

Doctor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine, Thammasat University

Khlong Luang, Changwat Pathum Thani, Thailand

Countries

Thailand

References

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.

Reference Type: DERIVED

PMID: 39620153 (View on PubMed)

Study Documents

Document Type: Study Protocol

View Document

Other Identifiers

Thammasat University

Identifier Type: OTHER

Identifier Source: secondary_id

MTU-EC-PS-1-304/64

Identifier Type: -

Identifier Source: org_study_id