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

Not Applicable

• Conditions: Insomnia Due to Mental Disorder
• Interventions: Device: Placebo acupuncture; Device: Electroacupuncture(EA); Other: Standard care

• Registration Number: NCT03122080
• Lead Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine

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.

Study Timeline

• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-20
• Study Start: 2017-11-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-07
• Last Update Posted: 2019-04-09
• Primary Completion: 2019-06-01
• Study Completion: 2019-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 270

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control A group	Placebo acupuncture	placebo acupuncture+standard care
Electroacupuncture group	Electroacupuncture(EA)	electroacupuncture+standard care
Control B group	Standard care	standard care

Primary Outcome Measures

Name	Time	Method
Pittsburgh Sleep Quality Index (PSQI)	8 week post-treatment	The Pittsburgh Sleep Quality Index (PSQI) is a widely-used questionnaire to assess one's sleep disorders over one month. It is comprised of 19 self-rated items and 5 other-rated items. The scores include the following indicators: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of medication, and daytime dysfunction. Each indicator is rated from 0 to 3. The accumulated scores of the seven indicators constitute the total score of PSQI (0-21). The higher score indicates the worse sleep quality and severer sleep disorders. The investigators set the PSQI score at 8th week post-treatment as the primary outcome, compared with PSQI scores at other time points, to evaluate the effectiveness of acupuncture for depression related insomnia.

Secondary Outcome Measures

Name	Time	Method
Self-rating Anxiety Scale (SAS)	baseline, 4 week, 8 week post-treatment	The Self-rating Anxiety Scale (SAS) is primarily used as a measure of somatic symptoms associated with anxiety. In using the scale, the participant will be asked to rate each item from 0-3 points according to how it applies to him or her within the past week. The standard score is the sum of the integer part of 1.25 times the raw score of the 20 items. A standard score of more than 50 points means the subject has anxious symptoms. A higher score indicates a more serious case of anxiety.
Actigraphy	baseline, 4 week post-treatment, 8 week post-treatment	Actigraphy (wActiSleep-BT. LLC, Pensacola, USA), which is worn on the patient's wrist, can monitor the quality of sleep, such as sleep onset, sleep latency, total sleep time, sleep awakenings during the night, duration of sleep, and sleep efficiency. The software ActiLife6 (Version 6.8.1, ActiGraph, LLC) will be used to analyze every participant's sleep condition recorded in the actigraphy.
Hamilton Rating Scale for Depression (HAMD)	baseline, 4 week post-treatment, 8 week post-treatment, 1 month, 3 month, 6 month follow-up	The Hamilton Rating Scale for Depression (HAMD), an observer-rating questionnaire with 17 items to describe the severity of cognitive and bodily symptoms of depressive disorders. Each item is rated in 3- or 5-point scales. The higher total score indicates the severer depression.
Changes of PSQI scores from baseline to 6 month follow-up	baseline, 4 week post-treatment, 8 week post-treatment, 1 month,3 month, 6 month follow-up	As is mentioned above, PSQI is a widely-used questionnaire to assess one's sleep disorders over one month. In order to assess the effects of acupuncture on patients' sleep quality during the intervention period, and to assess the durative effects of acupuncture after the intervention ends, the investigators set the changes of PSQI scores between baseline to 6 month follow-up as the secondary outcome.
Dose dairy	baseline, 4 week, 8 week post-treatment, 1 month, 3 month, 6 month follow-up	The dose dairy is a notebook where participants will be required to record their daily dose of antidepressants or sedative-hypnotics from baseline to 6 months follow-up, as well as the dosage time.

Trial Locations

Locations (1)

Shanghai Municipal Hospital of Traditional Chinese Medicine; 🇨🇳 Shanghai, Shanghai, China