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

Shanghai Municipal Hospital of Traditional Chinese Medicine

Status: Unknown

Conditions: Insomnia Due to Mental Disorder

Treatments: Device: Placebo acupuncture; Other: Standard care; Device: Electroacupuncture(EA)

Study type: Interventional

Funder types: Other

Identifiers

NCT03122080

SHMHTCM Shifen Xu

Details and patient eligibility

About

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

Full description

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female participants aged 18-70;
2. Participants who meet the diagnostic criteria of depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV);
3. Participants whose HAMD score is 20-35;
4. Participants who have complaint about insomnia at the first visit to the doctor;
5. Participants whose PSQI score is more than 7;
6. Participants who voluntarily agree with the investigation and sign a written informed consent form for the clinical trial.

Exclusion criteria

1. Participants with secondary depressive disorders caused by organic diseases, medicine, or psychotic disorders including schizophrenia, etc;
2. Participants who are in the depressive episode of bipolar disorder, or suffering from dysthymia, reactive depression and depressive syndrome caused by other diseases;
3. Participants with alcohol abuse or drug dependence;
4. Participants who refuse to wear the Actigraphy during the trial;
5. Pregnant or lactating women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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270 participants in 3 patient groups, including a placebo group

Electroacupuncture group

Active Comparator group

Description:

electroacupuncture+standard care

Treatment:

Device: Electroacupuncture(EA)

Control A group

Placebo Comparator group

Description:

placebo acupuncture+standard care

Treatment:

Device: Placebo acupuncture

Control B group

Other group

Description:

standard care

Treatment:

Other: Standard care