Effect of Electroacupuncture and Counseling on Sub-Threshold Depression: A Study Protocol for a Multicenter Randomized Controlled Trial

Xiaotong Wang; Haixiong Lin; Xiumin Jiang; Minna Ma; Dandan Shi; Chun Fan; Yin Shao; Shengwei Wu; Lin Yu; Danian Li; Jun He; Yongjun Chen

doi:10.3389/fpsyt.2020.00346

Effect of Electroacupuncture and Counseling on Sub-Threshold Depression: A Study Protocol for a Multicenter Randomized Controlled Trial

Front Psychiatry. 2020 Apr 28:11:346. doi: 10.3389/fpsyt.2020.00346. eCollection 2020.

Authors

Xiaotong Wang¹, Haixiong Lin², Xiumin Jiang¹, Minna Ma³, Dandan Shi³, Chun Fan¹, Yin Shao¹, Shengwei Wu⁴, Lin Yu⁴, Danian Li⁵, Jun He^{1

5}, Yongjun Chen^{1

6}

Affiliations

¹ South China Research Center for Acupuncture and Moxibustion, Clinical Medical College of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China.
² The First School of Clinical Medicine, Guangzhou University of Chinese Medicine, Guangzhou, China.
³ Student Mental Health Counseling Center, Guangzhou University of Chinese Medicine, Guangzhou, China.
⁴ Department of Traditional Chinese Medicine, Affiliated Brain Hospital of Guangzhou Medical University, Guangzhou, China.
⁵ Rehabilitation Center, Counseling Department, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
⁶ Guangdong-Hong Kong-Macao Greater Bay Area Center for Brain Science and Brain-Inspired Intelligence, Guangdong Province Key Laboratory of Psychiatric Disorders, Guangzhou, China.

Abstract

Background: Sub-threshold depression is common and could impair function, as well as increase the risk of developing major depression. Despite evidence of efficacy for electroacupuncture (EA) and counseling in the treatment of sub-threshold depression, the sample size is insufficient and the level of evidence remains low. This study aims to evaluate the effectiveness of sub-threshold depression treatments by comparing the treatment effects among EA, counseling, and combination therapy, as well as to further study their mechanism.

Methods: This study is a multicenter, randomized, single blind clinical trial that will be conducted in settings at four clinical centers in China. The randomized controlled trial (RCT) will examine the effectiveness of EA intervention, compared with counseling and combination therapy. A total of 138 sub-threshold depression patients (18 to 55 years of age with Beck Depression Inventory (BDI-II) score ≥ 14 points and Hamilton Depression Scale (HAMD-17) score: 7 points ≤ HAMD total score <17 points) will be recruited. The participants will be randomly assigned to receive the above treatments. The interventions will be delivered over a 6-week period (EA: 3 times a week for 6 weeks; 30 min a session. Counseling: once a week for 6 weeks; 50-60 min a session). The primary outcome measure will be the HAMD-17; BDI-II. The secondary outcome measures will be: Self-rating Depression Scale (SDS), Self-rating Anxiety Scale (SAS), and Pittsburgh Sleep Quality Index (PSQI). The assessments will occur at baseline, 2, 4, and 6 weeks and a follow-up period. Recruitment will commence in March 2020 and is anticipated to occur over a 2-year period.

Discussion: This study intends to conduct a multicenter randomized controlled trial to compare the effectiveness among EA, counseling and the combined therapy in the treatment of patients with sub-threshold depression, and to further study the mechanisms of effect.

Chinese clinical trial registry registration: www.chictr.org.cn/, identifier ChiCTR1900028530.

Keywords: counselling; electroacupuncture; protocol; randomized controlled trial; sub-threshold depression.