Effect of Electroacupuncture and Counseling on Sub-Threshold Depression: A Study Protocol for a Multicenter Randomized Controlled Trial.
counselling
electroacupuncture
protocol
randomized controlled trial
sub-threshold depression
Journal
Frontiers in psychiatry
ISSN: 1664-0640
Titre abrégé: Front Psychiatry
Pays: Switzerland
ID NLM: 101545006
Informations de publication
Date de publication:
2020
2020
Historique:
received:
25
02
2020
accepted:
06
04
2020
entrez:
16
5
2020
pubmed:
16
5
2020
medline:
16
5
2020
Statut:
epublish
Résumé
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. 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. 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. www.chictr.org.cn/, identifier ChiCTR1900028530.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
UNASSIGNED
www.chictr.org.cn/, identifier ChiCTR1900028530.
Identifiants
pubmed: 32411031
doi: 10.3389/fpsyt.2020.00346
pmc: PMC7198880
doi:
Types de publication
Journal Article
Langues
eng
Pagination
346Informations de copyright
Copyright © 2020 Wang, Lin, Jiang, Ma, Shi, Fan, Shao, Wu, Yu, Li, He and Chen.
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