Insomnia Due to Mental Disorder Clinical Trial
Official title:
Efficacy and Safety of Electroacupuncture on Treating Depression Related Insomnia: Study Protocol for a Multicenter Randomized Controlled Trial
The investigators describe a protocol for a multicenter randomized controlled trial to find out the efficacy of electroacupuncture for depression related insomnia.
Sleep difficulties are among the main symptoms presented by depressed patients, and they can
profoundly impact course of illness. Acupuncture is a widely recognized therapy to treat
depressive disorders and sleep disturbances in clinical practice. This multicenter randomized
placebo-controlled trial is aimed to investigate the efficacy and safety of
electroacupuncture, sham acupuncture and standard medical care, administrated by professional
acupuncturists and psychiatrists, in depression patients with insomnia.
The investigators describe a protocol for a multicenter randomized controlled trial. Two
hundred seventy eligible patients in 3 different health-care centers in Shanghai will be
randomly assigned to one of 3 treatment groups: EA group (electroacupuncture+standard medical
care), Control A group (sham acupuncture+standard medical care) and Control B group (standard
medical care). Treatment will be given 3 times per week for 8 weeks. The primary outcomes is
the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes are sleep parameters
recorded in the Actigraphy, Hamilton Rating Scale for Depression (HAMD) score and Self-rating
Anxiety Scale (SAS) score. Daily dose of patients' antidepressant and sedative-hypnotic
medication will be recorded in the dairy. All adverse effects will be assessed by the
Treatment Emergent Symptom Scale (TESS). Outcomes will be evaluated at baseline, 4 weeks
post-treatment and 8 weeks post-treatment, as well as at 1 month, 3 months and 6 months
follow-up.
The findings from this trial will help further about the efficacy and safety of acupuncture
for depression related insomnia, as well as determine the differences between
electroacupuncture, sham acupuncture and standard medical care for treating insomnia and
depression.
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