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.
Highlights
Depression is frequently accompanied by sleep disturbances including insomnia
Except depressive disorders including negative emotions, anxiety, agitation, low self-esteem, and suicidal tendencies [3], major depressive disorder (MDD) is frequently accompanied by sleep disturbances such as insomnia or hypersomnia [4]
The relationship between insomnia and mood symptoms is bidirectional in that poor sleep can precede an episode of major depressive disorder, and depressive mood can disrupt normal sleep patterns [4]
Summary
Previous study identified major depressive disorder (MDD) as the second leading cause of disability worldwide and results in an enormous public health burden [1]. Acupuncture, as a widely recognized alternative therapy in clinical practice, has been used to treat depressive disorders and related sleep disturbances recently. To study the clinical effects of electroacupuncture on treating insomnia and alleviating depression and to resolve some logic problems of present acupuncture researches, we design this randomized, parallel-group, and single-blinded clinical trial with a sufficient follow-up period. The results will be helpful to demonstrate if EA is an effective and safe therapy for improving sleep quality and mental health for patients with depression. The findings will be shared with the healthcare professionals, general public, and relevant organizations through publication of manuscripts and conference presentations
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
