title: Efficacy and Safety of Electroacupuncture on Treating Depression Related Sleep Disorders: Study Protocol of a Randomized Controlled Trial.
abstract: Background. Depression is frequently accompanied by sleep disturbances including insomnia. Insomnia may persist even after mood symptoms have been adequately treated. Acupuncture is considered to be beneficial to adjust the state of body and mind and restore the normal sleep-awake cycle. This trial is aimed at evaluating the efficacy and safety of electroacupuncture on treating insomnia in patients with depression.Methods. We describe a protocol for a randomized, single-blinded, sham controlled trial. Ninety eligible patients will be randomly assigned to one of 3 treatment groups: treatment group (acupuncture), control A group (superficial acupuncture at sham points), and control B group (sham acupuncture). All treatment will be given 3 times per week for 8 weeks. The primary outcome is the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes are sleep parameters recorded in the Actigraphy, Hamilton Rating Scale for Depression (HAMD), and Self-Rating Depression Scale (SDS). All adverse effects will be accessed by the Treatment Emergent Symptom Scale (TESS). Outcomes will be evaluated at baseline, 4 weeks after treatment, 8 weeks after treatment, and 4 weeks of follow-up.Ethics. This trial has been approved by the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine (2015SHL-KY-21) and is registered with ChiCTR-IIR-16008058.
authors.affiliation: Shanghai Municipal Hospital of Traditional Chinese Medicine Shanghai, Shanghai University of TCM, Shanghai 200071, China.
authors.forename: Xuan
authors.initials: X
authors.lastname: Yin
authors.affiliation: Shanghai Municipal Hospital of Traditional Chinese Medicine Shanghai, Shanghai University of TCM, Shanghai 200071, China.
authors.forename: Jian
authors.initials: J
authors.lastname: Xu
authors.affiliation: Shanghai Municipal Hospital of Traditional Chinese Medicine Shanghai, Shanghai University of TCM, Shanghai 200071, China.
authors.forename: Bo
authors.initials: B
authors.lastname: Dong
authors.affiliation: Shanghai Municipal Hospital of Traditional Chinese Medicine Shanghai, Shanghai University of TCM, Shanghai 200071, China.
authors.forename: Jie
authors.initials: J
authors.lastname: Ma
authors.affiliation: Shanghai Municipal Hospital of Traditional Chinese Medicine Shanghai, Shanghai University of TCM, Shanghai 200071, China.
authors.forename: Zeqin
authors.initials: Z
authors.lastname: Chen
authors.affiliation: Shanghai Municipal Hospital of Traditional Chinese Medicine Shanghai, Shanghai University of TCM, Shanghai 200071, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Yin
authors.affiliation: Shanghai Municipal Hospital of Traditional Chinese Medicine Shanghai, Shanghai University of TCM, Shanghai 200071, China.
authors.forename: Junyi
authors.initials: J
authors.lastname: Wu
authors.affiliation: Shanghai Municipal Hospital of Traditional Chinese Medicine Shanghai, Shanghai University of TCM, Shanghai 200071, China.
authors.forename: Bochang
authors.initials: B
authors.lastname: Zhu
authors.affiliation: Shanghai Municipal Hospital of Traditional Chinese Medicine Shanghai, Shanghai University of TCM, Shanghai 200071, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Cao
authors.affiliation: Shanghai Municipal Hospital of Traditional Chinese Medicine Shanghai, Shanghai University of TCM, Shanghai 200071, China.
authors.forename: Huimin
authors.initials: H
authors.lastname: Zheng
authors.affiliation: School of Chinese Medicine, The University of Hong Kong, 10 Sassoon Road, Pokfulam, Hong Kong; Center for Integrative Medicine, School of Medicine, University of Maryland, Baltimore, MD 21201, USA.
authors.forename: Lixing
authors.initials: L
authors.lastname: Lao
authors.affiliation: Shanghai Municipal Hospital of Traditional Chinese Medicine Shanghai, Shanghai University of TCM, Shanghai 200071, China.
authors.forename: Shifen
authors.identifier: 0000-0001-5595-3480
authors.initials: S
authors.lastname: Xu