Clinical trial NCT03122080: Efficacy of EA on Depression Related Insomnia: Study Protocol for a Multicenter RCT
Official title: Efficacy and Safety of Electroacupuncture on Treating Depression Related Insomnia: Study Protocol for a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia Due to Mental Disorder
Keywords: acupuncture
insomnia
depression
antidepressants
Lead sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai University of Traditional Chinese Medicine
name: Changhai Hospital
name: Shanghai Mental Health Center
First posted: 2017-04-20
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 8 week post-treatment
Secondary outcomes:
measure: Changes of PSQI scores from baseline to 6 month follow-up
timeFrame: baseline, 4 week post-treatment, 8 week post-treatment, 1 month,3 month, 6 month follow-up
measure: Actigraphy
timeFrame: baseline, 4 week post-treatment, 8 week post-treatment
measure: Hamilton Rating Scale for Depression (HAMD)
timeFrame: baseline, 4 week post-treatment, 8 week post-treatment, 1 month, 3 month, 6 month follow-up
measure: Self-rating Anxiety Scale (SAS)
timeFrame: baseline, 4 week, 8 week post-treatment
measure: Dose dairy
timeFrame: baseline, 4 week, 8 week post-treatment, 1 month, 3 month, 6 month follow-up
Other outcomes:
measure: Adverse effects
timeFrame: baseline, 4 week post-treatment, 8 week post-treatment, 1 month, 3 month, 6 month follow-up.
Locations:
city: Shanghai
country: China
facility: Shanghai Municipal Hospital of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Municipal Hospital of TCM
name: Shifen Xu, PhD
role: STUDY_DIRECTOR
affiliation: Shanghai Mental Health Center
name: Xia Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Shuang Zhou
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yin X, Li W, Liang T, Lu B, Yue H, Li S, Zhong VW, Zhang W, Li X, Zhou S, Mi Y, Wu H, Xu S. Effect of Electroacupuncture on Insomnia in Patients With Depression: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2220563. doi: 10.1001/jamanetworkopen.2022.20563.
citation: Yin X, Dong B, Liang T, Yin P, Li X, Lin X, Zhou S, Qian X, Lao L, Xu S. Efficacy and safety of electroacupuncture on treating depression-related insomnia: a study protocol for a multicentre randomised controlled trial. BMJ Open. 2019 Apr 20;9(4):e021484. doi: 10.1136/bmjopen-2018-021484.