Efficacy of EA on Depression Related Insomnia: Study Protocol for a Multicenter RCT

Summary

The investigators describe a protocol for a multicenter randomized controlled trial to find out the efficacy of electroacupuncture for depression related insomnia.

Conditions

• Insomnia Due to Mental Disorder

Interventions

DEVICE

Electroacupuncture(EA)

Participants in EA group will receive electroacupuncture treatment. Acupuncture will be applied at Baihui (GV20), Shenting (GV24), Yintang (GV29), bilateral Anmian (EX-HN22), Shenmen (HT7), SanYinjiao (SP6) and Neiguan (PC6). After needle insertion, rotating or lifting-thrusting manipulation will be applied for "Deqi" sensation. The EA apparatus (CMNS6-1, Jianjian Medical Device CO., LTD, China) will be connected to the needles at GV20 and GV29 for 30 minutes and deliver a continuous wave. The frequency will be set at about 30 Hz and the amplitude will be less than 20V. Participants can regularly take the antidepressants or sedative-hypnotics as before during the intervention. Besides, the investigators will strengthen health education about insomnia and depression for the patients.

DEVICE

Placebo acupuncture

Participants in the control A group will receive placebo acupuncture treatment with streitberger needles at the same acupoints as the electroacupuncture group. When the tip of the blunt needles touches to the skin, the patient will get a pricking sensation but there is no real needle inserted into the skin. The electroacupuncture apparatus will be set beside the patients, with no connection to the needles. Inform the patients when removing the needles after 30 minutes. Use the dry cotton ball to press the acupoints so that patients can feel the withdrawal of the 'needles'. Same health education and regular administration of antidepressants or sedative-hypnotics will be given to the participants during the intervention.

OTHER

Standard care

Participants in the control B group will keep their standard medical care for the first 8 weeks. Participants will take their regular antidepressants and the sedative-hypnotics during the whole intervention period. Same health education will be conducted as well for the participants. And after waiting for two months, these patients will be treated with the same electroacupuncture treatment as the EA group.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine

  collaborator OTHER

• Changhai Hospital

  collaborator OTHER

• Shanghai Mental Health Center

  collaborator OTHER

• Shanghai Municipal Hospital of Traditional Chinese Medicine

  lead OTHER

Principal Investigators

• Shifen Xu, PhD · Shanghai Municipal Hospital of TCM

• Xia Li · Shanghai Mental Health Center

• Shuang Zhou · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-01

Primary Completion

2019-06-01

Completion

2019-12-30

Countries

• China

Study Locations